Type 2 Diabetes Mellitus
Conditions
Brief summary
An overall study of the cardiovascular outcomes following treatment with ertugliflozin in participants with type 2 diabetes mellitus (T2DM) and established vascular disease. The main objective of this study is to assess the cardiovascular safety of ertugliflozin. This trial includes 3 pre-defined glycemic sub-studies; 1. In participants receiving background insulin with or without metformin, 2. In participants receiving background sulfonylurea monotherapy, and 3. In participants receiving background metformin with sulfonylurea (all fully-enrolled). Participants enrolled prior to Amendment 1 were in the overall study as well as a sub-study, if they met certain entry criteria. Participants enrolled following the start of Amendment 1 were only enrolled in the overall study. The sub-studies were the initial 18 weeks of the overall study period.
Detailed description
The primary hypotheses for the 4 studies are: 1. Overall Cardiovascular Study: The time to first occurrence of the composite endpoint of MACE: cardiovascular death, non-fatal myocardial infarction \[MI\] or non-fatal stroke in participants treated with ertugliflozin is non-inferior compared to that in participants treated with placebo. 2. The 3 Glycemic Sub-studies: 1. The mean reduction from baseline in hemoglobin A1c (A1C) for 15 mg ertugliflozin is greater than that for placebo. 2. The mean reduction from baseline in A1C for 5 mg ertugliflozin is greater than that for placebo.
Interventions
DRUGErtugliflozin
Oral, once daily, for up to approximately 6 years
DRUGPlacebo
Matching placebo to ertugliflozin administered orally, once daily, for up to approximately 6 years
DRUGGlycemic Rescue
Doses of background anti-hyperglycemic agents (AHA), medications will be required to be held constant in all participants enrolled for the initial 18 weeks of the trial with 2 exceptions: First, participant will be prescribed glycemic rescue therapy if they meet specific, progressively more stringent, glycemic thresholds based on repeated, confirmed fasting plasma glucose (FPG) measured at a central laboratory. Second, a participant experiencing clinically significant hypoglycemia according to the investigator at any time during the trial is permitted to have the dose of appropriate background AHA (e.g., insulin, sulfonylurea \[SU\], glinide) reduced or discontinued as per the judgment of the investigator or the treating physician. Choice and dosing of glycemic rescue will be at the discretion of the investigator or the treating physician consistent with standards of care for management of patients with Type 2 diabetes mellitus (T2DM) within the country of the investigational site.
Sponsors
Pfizer
Merck Sharp & Dohme LLC
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE (Subject, Investigator)
Eligibility
Sex/Gender
ALL
Age
40 Years to No maximum
Healthy volunteers
No
Inclusion criteria
(Overall Cardiovascular Study): * Diagnosis of T2DM in accordance with American Diabetes Association (ADA) guidelines * Hemoglobin A1c (A1C) at the start of study participation of 7.0-10.5% (53-91 mmol/mol) * On stable allowable anti-hyperglycemic agents (AHA) or on no background AHA for at least 8 weeks prior to the study participation * Body Mass Index (BMI) \> or = to 18.0 kg/m\^2 * Evidence or a history of atherosclerosis involving the coronary, cerebral or peripheral vascular systems * There is adequate documentation of the objective evidence that the participant has established vascular disease such as investigational site's medical records, copies of such records from other institutions, or a letter from a referring physician that specifically states the diagnosis and date of the most recent occurrence of the qualifying event(s) or procedure(s). * Male, female not or reproductive potential, or female of reproductive potential who agrees to be abstinent from heterosexual activity or agrees to use or have their partner use 2 acceptable methods of contraception
Exclusion criteria
(Overall Cardiovascular Study): * Previous randomization into this trial * Experiencing a cardiovascular event (myocardial infarction or stroke) or undergoing coronary angioplasty or peripheral intervention procedure between the Screening Visit and randomization * Undergoing any cardiovascular surgery (valvular surgery) within 3 months of study participation * Planned revascularization or peripheral intervention procedure or other cardiovascular surgery * New York Heart Association (NYHA) IV heart failure at study participation * History of type 1 diabetes mellitus or a history of ketoacidosis Key Inclusion Criteria for the 3 Glycemic Sub-studies: 1. Insulin With or Without Metformin Sub-study: Stable doses of insulin (\>=20 units/day, with variations up to 10% in the daily dose permitted) with or without metformin (\>=1500 mg/day) for at least 8 weeks prior to the time of the Screening Visit (V1) and during the period between the Screening Visit (V1) and randomization. 2. Sulfonylurea (SU) Monotherapy Sub-study: Participants receiving a stable dose of SU monotherapy for at least 8 weeks prior to the time of the Screening Visit (V1) and during the period between the Screening Visit (V1) and randomization. 3. Metformin with SU Sub-study: Participants receiving a stable dose metformin (≥1500 mg/day) with a SU for at least 8 weeks prior to the time of the Screening Visit (V1) and during the period between the Screening Visit (V1) and randomization.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Time to First Occurrence of MACE (Composite Endpoint of Major Adverse Cardiovascular Events [Cardiovascular Death, Non-fatal Myocardial Infarction or Non-fatal Stroke]) (On-Treatment + 365-day Approach) (Overall Cardiovascular Study) | Up to approximately 6 years | Time to the first occurrence of any of the following adjudicated components of the primary composite endpoint (3-point major adverse cardiovascular events (MACE)): cardiovascular (CV) death (including fatal stroke and fatal myocardial infarction (MI)), non-fatal MI, and non-fatal stroke. The on-treatment approach included confirmed events that occurred between the date of first dose of study medication and the on-treatment censor date. Person-years was calculated as the sum of participants' time to first event or time to censoring (the earliest of participants' end of study date, death date, last contact date, or 365 days after the last dose). |
| Baseline Hemoglobin A1C (A1C) (Insulin With or Without Metformin Add-on Glycemic Sub-study) | Baseline | A1C is a blood marker used to report average blood glucose levels over prolonged periods of time and is reported as a percentage (%). A1C represents the percentage of glycated hemoglobin. This baseline reflects the Week 0 A1C. |
| Change From Baseline in Hemoglobin A1C (A1C) at Week 18 - Excluding Rescue Approach (Insulin With or Without Metformin Add-on Glycemic Sub-study) | Baseline and Week 18 | A1C is a blood marker used to report average blood glucose levels over prolonged periods of time and is reported as a percentage (%). A1C represents the percentage of glycated hemoglobin. This change from baseline reflects the Week 18 A1C minus the Week 0 A1C. A negative number indicates a reduction in A1C level. Participants who met glycemic rescue criteria received glycemic rescue medication. Excluding Rescue excluded all data following the initiation of rescue in order to avoid the confounding influence of the rescue therapy. |
| Baseline Hemoglobin A1C (A1C) (Sulfonylurea Monotherapy Add-on Glycemic Sub-Study) | Baseline | A1C is a blood marker used to report average blood glucose levels over prolonged periods of time and is reported as a percentage (%). A1C represents the percentage of glycated hemoglobin. This baseline reflects the Week 0 A1C. |
| Change From Baseline in Hemoglobin A1C (A1C) at Week 18 - Excluding Rescue Approach (Sulfonylurea Monotherapy Add-on Glycemic Sub-Study) | Baseline and Week 18 | A1C is a blood marker used to report average blood glucose levels over prolonged periods of time and is reported as a percentage (%). A1C represents the percentage of glycated hemoglobin. This change from baseline reflects the Week 18 A1C minus the Week 0 A1C. A negative number indicates a reduction in A1C level. Participants who met glycemic rescue criteria received glycemic rescue medication. Excluding Rescue excluded all data following the initiation of rescue in order to avoid the confounding influence of the rescue therapy. |
| Baseline Hemoglobin A1C (A1C) (Metformin With Sulfonylurea Add-on Glycemic Sub-study) | Baseline | A1C is a blood marker used to report average blood glucose levels over prolonged periods of time and is reported as a percentage (%). A1C represents the percentage of glycated hemoglobin. This baseline reflects Week 0 A1C. |
| Change From Baseline in Hemoglobin A1C (A1C) at Week 18 - Excluding Rescue Approach (Metformin With Sulfonylurea Add-on Glycemic Sub-study) | Baseline and Week 18 | A1C is a blood marker used to report average blood glucose levels over prolonged periods of time and is reported as a percentage (%). A1C represents the percentage of glycated hemoglobin. This change from baseline reflects the Week 18 A1C minus the Week 0 A1C. A negative number indicates a reduction in A1C level. Participants who met glycemic rescue criteria received glycemic rescue medication. Excluding Rescue excluded all data following the initiation of rescue in order to avoid the confounding influence of the rescue therapy. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Time to First Occurrence of Hospitalization for Heart Failure (HHF) (On-Study Approach) (Overall Cardiovascular Study) | Up to approximately 6 years | Time to the first occurrence of heart failure requiring hospitalization (adjudicated). The on-study approach included confirmed events that occurred between the randomization date and the on-study censor date. Person-years was calculated as the sum of participants' time to first event or time to censoring (the earliest of participants' end of study date, death date, or last contact date). The on-study approach included events that occurred between the randomization date and the on-study censor date. |
| Time to Occurrence of Death From Any Cause (On-Study Approach) (Overall Cardiovascular Study) | Up to approximately 6 years | Time to the occurrence of death from any cause. The on-study approach included confirmed events that occurred between the randomization date and the on-study censor date. Person-years was calculated as the sum of participants' time to event or time to censoring (the earliest of participants' end of study date, death date, last contact date, or date last known to be alive. The on-study approach included events that occurred between the randomization date and the on-study censor date. |
| Andersen-Gill Model for Total MACE (On-Study Approach) (Overall Cardiovascular Study) | Up to approximately 6 years | All events (first and recurrent) of the composite of MACE (3-point major adverse cardiovascular events: cardiovascular (CV) death (including fatal stroke and fatal myocardial infarction (MI)), non-fatal MI, and non-fatal stroke) were assessed using Andersen-Gill model. The on-study approach included events that occurred between the randomization date and the on-study censor date. |
| Andersen-Gill Model for All Cardiovascular Death (CV Death) or Hospitalizations for Heart Failure (HFF) (On-Study Approach) (Overall Cardiovascular Study) | Up to approximately 6 years | All events (first and recurrent) of the composite of CV death and HHF were assessed using an Andersen-Gill model. Person-years were calculated as the sum of time from randomization to end of follow-up. The on-study approach included events that occurred between the randomization date and the on-study censor date. |
| Change From Baseline in Hemoglobin A1C (A1C) at Week 18 - Excluding Rescue Approach (Overall Cardiovascular Study) | Baseline and Week 18 | A1C is a blood marker used to report average blood glucose levels over prolonged periods of time and is reported as a percentage (%). A1C represents the percentage of glycated hemoglobin. This change from baseline reflects the Week 18 A1C minus the Week 0 A1C. A negative number indicates a reduction in A1C level. Participants who met glycemic rescue criteria received glycemic rescue medication. Excluding Rescue excluded all data following the initiation of rescue in order to avoid the confounding influence of the rescue therapy. |
| Change From Baseline in A1C at Week 52 (Overall Cardiovascular Study) | Baseline and Week 52 | A1C is a blood marker used to report average blood glucose levels over prolonged periods of time and is reported as a percentage (%). A1C represents the percentage of glycated hemoglobin. This change from baseline reflects the Week 52 A1C minus the Week 0 A1C. A negative number indicates a reduction in A1C level. Participants who met glycemic rescue criteria received glycemic rescue medication. |
| Change From Baseline in Body Weight at Month 72 (Overall Cardiovascular Study) | Baseline and Month 72 | This change from baseline reflects the Month 72 body weight minus the Week 0 body weight. A negative number indicates a reduction in body weight. Participants who met glycemic rescue criteria received glycemic rescue medication. |
| Change From Baseline in A1C at Month 36 (Overall Cardiovascular Study) | Baseline and Month 36 | A1C is a blood marker used to report average blood glucose levels over prolonged periods of time and is reported as a percentage (%). A1C represents the percentage of glycated hemoglobin. This change from baseline reflects the Month 36 A1C minus the Week 0 A1C. A negative number indicates a reduction in A1C level. Participants who met glycemic rescue criteria received glycemic rescue medication. |
| Change From Baseline in A1C at Month 48 (Overall Cardiovascular Study) | Baseline and Month 48 | A1C is a blood marker used to report average blood glucose levels over prolonged periods of time and is reported as a percentage (%). A1C represents the percentage of glycated hemoglobin. This change from baseline reflects the Month 48 A1C minus the Week 0 A1C. A negative number indicates a reduction in A1C level. Participants who met glycemic rescue criteria received glycemic rescue medication. |
| Change From Baseline in A1C at Month 60 (Overall Cardiovascular Study) | Baseline and Month 60 | A1C is a blood marker used to report average blood glucose levels over prolonged periods of time and is reported as a percentage (%). A1C represents the percentage of glycated hemoglobin. This change from baseline reflects the Month 60 A1C minus the Week 0 A1C. A negative number indicates a reduction in A1C level. Participants who met glycemic rescue criteria received glycemic rescue medication. |
| Change From Baseline in A1C at Month 72 (Overall Cardiovascular Study) | Baseline and Month 72 | A1C is blood marker used to report average blood glucose levels over prolonged periods of time and is reported as a percentage (%). A1C represents the percentage of glycated hemoglobin. This change from baseline reflects the Month 72 A1C minus the Week 0 A1C. A negative number indicates a reduction in A1C level. Participants who met glycemic rescue criteria received glycemic rescue medication. |
| Percentage of Participants With an A1C <7% (<53 mmol/Mol) at Week 18 (Overall Cardiovascular Study) | Week 18 | A1C is a blood marker used to report average blood glucose levels over prolonged periods of time and is reported as a percentage (%). A1C represents the percentage of glycated hemoglobin. Participants who met glycemic rescue criteria received glycemic rescue medication. |
| Percentage of Participants With an A1C <7% (<53 mmol/Mol) at Week 52 (Overall Cardiovascular Study) | Week 52 | A1C is a blood marker used to report average blood glucose levels over prolonged periods of time and is reported as a percentage (%). A1C represents the percentage of glycated hemoglobin. Participants who met glycemic rescue criteria received glycemic rescue medication. |
| Percentage of Participants With an A1C <7% (<53 mmol/Mol) at Month 24 (Overall Cardiovascular Study) | Month 24 | A1C is a blood marker used to report average blood glucose levels over prolonged periods of time and is reported as a percentage (%). A1C represents the percentage of glycated hemoglobin. Participants who met glycemic rescue criteria received glycemic rescue medication. |
| Percentage of Participants With an A1C <7% (<53 mmol/Mol) at Month 36 (Overall Cardiovascular Study) | Month 36 | A1C is a blood marker used to report average blood glucose levels over prolonged periods of time and is reported as a percentage (%). A1C represents the percentage of glycated hemoglobin. Participants who met glycemic rescue criteria received glycemic rescue medication. |
| Percentage of Participants With an A1C <7% (<53 mmol/Mol) at Month 48 (Overall Cardiovascular Study) | Month 48 | A1C is a blood marker used to report average blood glucose levels over prolonged periods of time and is reported as a percentage (%). A1C represents the percentage of glycated hemoglobin. Participants who met glycemic rescue criteria received glycemic rescue medication. |
| Percentage of Participants With an A1C <7% (<53 mmol/Mol) at Month 60 (Overall Cardiovascular Study) | Month 60 | A1C is a blood marker used to report average blood glucose levels over prolonged periods of time and is reported as a percentage (%). A1C represents the percentage of glycated hemoglobin. Participants who met glycemic rescue criteria received glycemic rescue medication. |
| Percentage of Participants With an A1C <6.5% (<48 mmol/Mol) at Week 18 (Overall Cardiovascular Study) | Week 18 | A1C is a blood marker used to report average blood glucose levels over prolonged periods of time and is reported as a percentage (%). A1C represents the percentage of glycated hemoglobin. Participants who met glycemic rescue criteria received glycemic rescue medication. |
| Percentage of Participants With an A1C <6.5% (<48 mmol/Mol) at Week 52 (Overall Cardiovascular Study) | Week 52 | A1C is a blood marker used to report average blood glucose levels over prolonged periods of time and is reported as a percentage (%). A1C represents the percentage of glycated hemoglobin. Participants who met glycemic rescue criteria received glycemic rescue medication. |
| Percentage of Participants With an A1C <6.5% (<48 mmol/Mol) at Month 24 (Overall Cardiovascular Study) | Month 24 | A1C is a blood marker used to report average blood glucose levels over prolonged periods of time and is reported as a percentage (%). A1C represents the percentage of glycated hemoglobin. Participants who met glycemic rescue criteria received glycemic rescue medication. |
| Percentage of Participants With an A1C <6.5% (<48 mmol/Mol) at Month 36 (Overall Cardiovascular Study) | Month 36 | A1C is a blood marker used to report average blood glucose levels over prolonged periods of time and is reported as a percentage (%). A1C represents the percentage of glycated hemoglobin. Participants who met glycemic rescue criteria received glycemic rescue medication. |
| Percentage of Participants With an A1C <6.5% (<48 mmol/Mol) at Month 48 (Overall Cardiovascular Study) | Month 48 | A1C is a blood marker used to report average blood glucose levels over prolonged periods of time and is reported as a percentage (%). A1C represents the percentage of glycated hemoglobin. Participants who met glycemic rescue criteria received glycemic rescue medication. |
| Percentage of Participants With an A1C <6.5% (<48 mmol/Mol) at Month 60 (Overall Cardiovascular Study) | Month 60 | A1C is a blood marker used to report average blood glucose levels over prolonged periods of time and is reported as a percentage (%). A1C represents the percentage of glycated hemoglobin. Participants who met glycemic rescue criteria received glycemic rescue medication. |
| Change From Baseline in Fasting Plasma Glucose (FPG) at Week 18 (Excluding Rescue Approach) (Overall Cardiovascular Study) | Baseline and Week 18 | FPG was analyzed after an overnight fast. This change from baseline reflects the Week 18 FPG minus the Week 0 FPG. A negative number indicates a reduction in FPG. Participants who met glycemic rescue criteria received glycemic rescue medication. Excluding rescue, excluded all data following the initiation of rescue in order to avoid the confounding influence of the rescue therapy. |
| Change From Baseline in Fasting Plasma Glucose (FPG) at Week 52 (Overall Cardiovascular Study) | Baseline and Week 52 | FPG was analyzed after an overnight fast. This change from baseline reflects the Week 52 FPG minus the Week 0 FPG. A negative number indicates a reduction in FPG. Participants who met glycemic rescue criteria received glycemic rescue medication. |
| Change From Baseline in Fasting Plasma Glucose (FPG) at Month 24 (Overall Cardiovascular Study) | Baseline and Month 24 | FPG was analyzed after an overnight fast. This change from baseline reflects the Month 24 FPG minus the Week 0 FPG. A negative number indicates a reduction in FPG. Participants who met glycemic rescue criteria received glycemic rescue medication. |
| Change From Baseline in Fasting Plasma Glucose (FPG) at Month 36 (Overall Cardiovascular Study) | Baseline and Month 36 | FPG was analyzed after an overnight fast. This change from baseline reflects the Month 36 FPG minus the Week 0 FPG. A negative number indicates a reduction in FPG. Participants who met glycemic rescue criteria received glycemic rescue medication. |
| Change From Baseline in Fasting Plasma Glucose (FPG) at Month 48 (Overall Cardiovascular Study) | Baseline and Month 48 | FPG was analyzed after an overnight fast. This change from baseline reflects the Month 48 FPG minus the Week 0 FPG. A negative number indicates a reduction in FPG. Participants who met glycemic rescue criteria received glycemic rescue medication. |
| Change From Baseline in Fasting Plasma Glucose (FPG) at Month 60 (Overall Cardiovascular Study) | Baseline and Month 60 | FPG was analyzed after an overnight fast. This change from baseline reflects the Month 60 FPG minus the Week 0 FPG. A negative number indicates a reduction in FPG. Participants who met glycemic rescue criteria received glycemic rescue medication. |
| Change From Baseline in Fasting Plasma Glucose (FPG) at Month 72 (Overall Cardiovascular Study) | Baseline and Month 72 | FPG was analyzed after an overnight fast. This change from baseline reflects the Month 72 FPG minus the Week 0 FPG. A negative number indicates a reduction in FPG. Participants who met glycemic rescue criteria received glycemic rescue medication. |
| Time to the First Occurrence of a Participant Receiving Glycemic Rescue Therapy Through Week 18 (Overall Cardiovascular Study) | Up to 18 weeks | Participants who met glycemic rescue criteria received open-label sitagliptin glycemic rescue medication. |
| Time to Initiation of Insulin for Participants Not on Insulin at Baseline (Overall Cardiovascular Study) | Up to approximately 6 years | Participants who were not on insulin therapy at the start of study medication. |
| Baseline Insulin Dose for Participants Who Were on Insulin at Baseline (Overall Cardiovascular Study) | Baseline | Baseline reflects Week 0 insulin dose. |
| Change From Baseline in Insulin Dose at Week 18 for Participants Who Were on Insulin at Baseline (Overall Cardiovascular Study) | Baseline and Week 18 | This change from baseline reflects the Week 18 insulin dose minus the Week 0 insulin dose. A negative number indicates a reduction in the insulin dose. |
| Change From Baseline in Insulin Dose at Week 52 for Participants Who Were on Insulin at Baseline (Overall Cardiovascular Study) | Baseline and Week 52 | This change from baseline reflects the Week 52 insulin dose minus the Week 0 insulin dose. A negative number indicates a reduction in the insulin dose. |
| Change From Baseline in Insulin Dose at Month 24 for Participants Who Were on Insulin at Baseline (Overall Cardiovascular Study) | Baseline and Month 24 | This change from baseline reflects the Month 24 insulin dose minus the Week 0 insulin dose. A negative number indicates a reduction in the insulin dose. |
| Change From Baseline in Insulin Dose at Month 36 for Participants Who Were on Insulin at Baseline (Overall Cardiovascular Study) | Baseline and Month 36 | This change from baseline reflects the Month 36 insulin dose minus the Week 0 insulin dose. A negative number indicates a reduction in the insulin dose. |
| Change From Baseline in Insulin Dose at Month 48 for Participants Who Were on Insulin at Baseline (Overall Cardiovascular Study) | Baseline and Month 48 | This change from baseline reflects the Month 48 insulin dose minus the Week 0 insulin dose. A negative number indicates a reduction in the insulin dose. |
| Change From Baseline in Insulin Dose at Month 60 for Participants Who Were on Insulin at Baseline (Overall Cardiovascular Study) | Baseline and Month 60 | This change from baseline reflects the Month 60 insulin dose minus the Week 0 insulin dose. A negative number indicates a reduction in the insulin dose. |
| Change From Baseline in Sitting Systolic Blood Pressure (SBP) at Week 18 (Excluding Rescue Approach) (Overall Cardiovascular Study) | Baseline and Week 18 | This change from baseline reflects the Week 18 SBP minus the Week 0 SBP. A negative number indicates a reduction in SBP. Participants who met glycemic rescue criteria received glycemic rescue medication. Excluding rescue, excluded all data following the initiation of rescue in order to avoid the confounding influence of the rescue therapy. |
| Change From Baseline in Sitting Systolic Blood Pressure (SBP) at Week 52 (Overall Cardiovascular Study) | Baseline and Week 52 | This change from baseline reflects the Week 52 sitting SBP minus the Week 0 SBP. A negative number indicates a reduction in SBP. Participants who met glycemic rescue criteria received glycemic rescue medication. |
| Change From Baseline in Sitting Systolic Blood Pressure (SBP) at Month 24 (Overall Cardiovascular Study) | Baseline and Month 24 | This change from baseline reflects the Month 24 SBP minus the Week 0 SBP. A negative number indicates a reduction in SBP. Participants who met glycemic rescue criteria received glycemic rescue medication. |
| Change From Baseline in Sitting Systolic Blood Pressure (SBP) at Month 36 (Overall Cardiovascular Study) | Baseline and Month 36 | This change from baseline reflects the Month 36 SBP minus the Week 0 SBP. A negative number indicates a reduction in SBP. Participants who met glycemic rescue criteria received glycemic rescue medication. |
| Change From Baseline in Sitting Systolic Blood Pressure (SBP) at Month 48 (Overall Cardiovascular Study) | Baseline and Month 48 | This change from baseline reflects the Month 48 SBP minus the Week 0 SBP. A negative number indicates a reduction in SBP. Participants who met glycemic rescue criteria received glycemic rescue medication. |
| Change From Baseline in Sitting Systolic Blood Pressure (SBP) at Month 60 (Overall Cardiovascular Study) | Baseline and Month 60 | This change from baseline reflects the Month 60 SBP minus the Week 0 SBP. A negative number indicates a reduction in SBP. Participants who met glycemic rescue criteria received glycemic rescue medication. |
| Change From Baseline in Sitting Systolic Blood Pressure (SBP) at Month 72 (Overall Cardiovascular Study) | Baseline and Month 72 | This change from baseline reflects the Month 72 SBP minus the Week 0 SBP. A negative number indicates a reduction in SBP. Participants who met glycemic rescue criteria received glycemic rescue medication. |
| Change From Baseline in Sitting Diastolic Blood Pressure (DBP) at Week 18 (Excluding Rescue Approach) (Overall Cardiovascular Study) | Baseline and Week 18 | This change from baseline reflects the Week 18 DBP minus the Week 0 DBP. A negative number indicates a reduction in DBP. Participants who met glycemic rescue criteria received glycemic rescue medication. Excluding rescue, excluded all data following the initiation of rescue in order to avoid the confounding influence of the rescue therapy. |
| Change From Baseline in Sitting Diastolic Blood Pressure (DBP) at Week 52 (Overall Cardiovascular Study) | Baseline and Week 52 | This change from baseline reflects the Week 52 DBP minus the Week 0 DBP. A negative number indicates a reduction in DBP. Participants who met glycemic rescue criteria received glycemic rescue medication. |
| Change From Baseline in Sitting Diastolic Blood Pressure (DBP) at Month 24 (Overall Cardiovascular Study) | Baseline and Month 24 | This change from baseline reflects the Month 24 DBP minus the Week 0 DBP. A negative number indicates a reduction in DBP. Participants who met glycemic rescue criteria received glycemic rescue medication. |
| Change From Baseline in Sitting Diastolic Blood Pressure (DBP) at Month 36 (Overall Cardiovascular Study) | Baseline and Month 36 | This change from baseline reflects the Month 36 DBP minus the Week 0 DBP. A negative number indicates a reduction in DBP. Participants who met glycemic rescue criteria received glycemic rescue medication. |
| Change From Baseline in Sitting Diastolic Blood Pressure (DBP) at Month 48 (Overall Cardiovascular Study) | Baseline and Month 48 | This change from baseline reflects the Month 48 DBP minus the Week 0 DBP. A negative number indicates a reduction in DBP. Participants who met glycemic rescue criteria received glycemic rescue medication. |
| Change From Baseline in Sitting Diastolic Blood Pressure (DBP) at Month 60 (Overall Cardiovascular Study) | Baseline and Month 60 | This change from baseline reflects the Month 60 DBP minus the Week 0 DBP. A negative number indicates a reduction in DBP. Participants who met glycemic rescue criteria received glycemic rescue medication. |
| Change From Baseline in Sitting Diastolic Blood Pressure (DBP) at Month 72 (Overall Cardiovascular Study) | Baseline and Month 72 | This change from baseline reflects the Month 72 DBP minus the Week 0 DBP. A negative number indicates a reduction in DBP. Participants who met glycemic rescue criteria received glycemic rescue medication. |
| Change From Baseline in Body Weight at Week 18 (Excluding Rescue Approach) (Overall Cardiovascular Study) | Baseline and Week 18 | This change from baseline reflects the Week 18 body weight minus the Week 0 body weight. A negative number indicates a reduction in body weight. Participants who met glycemic rescue criteria received glycemic rescue medication. Excluding Rescue excluded all data following the initiation of rescue in order to avoid the confounding influence of the rescue therapy. |
| Change From Baseline in Body Weight at Week 52 (Overall Cardiovascular Study) | Baseline and Week 52 | This change from baseline reflects the Week 52 body weight minus the Week 0 body weight. A negative number indicates a reduction in body weight. Participants who met glycemic rescue criteria received glycemic rescue medication. |
| Change From Baseline in Body Weight at Month 24 (Overall Cardiovascular Study) | Baseline and Month 24 | This change from baseline reflects the Month 24 body weight minus the Week 0 body weight. A negative number indicates a reduction in body weight. Participants who met glycemic rescue criteria received glycemic rescue medication. |
| Change From Baseline in Body Weight at Month 36 (Overall Cardiovascular Study) | Baseline and Month 36 | This change from baseline reflects the Month 36 body weight minus the Week 0 body weight. A negative number indicates a reduction in body weight. Participants who met glycemic rescue criteria received glycemic rescue medication. |
| Change From Baseline in Body Weight at Month 48 (Overall Cardiovascular Study) | Baseline and Month 48 | This change from baseline reflects the Month 48 body weight minus the Week 0 body weight. A negative number indicates a reduction in body weight. Participants who met glycemic rescue criteria received glycemic rescue medication. |
| Change From Baseline in Body Weight at Month 60 (Overall Cardiovascular Study) | Baseline and Month 60 | This change from baseline reflects the Month 60 body weight minus the Week 0 body weight. A negative number indicates a reduction in body weight. Participants who met glycemic rescue criteria received glycemic rescue medication. |
| Change From Baseline in Estimated Glomerular Filtration Rate (eGFR) at Week 18 (Overall Cardiovascular Study) | Baseline and Week 18 | This change from baseline reflects the Week 18 eGFR minus the Week 0 eGFR. A negative number indicates a reduction in the eGFR level. |
| Change From Baseline in Estimated Glomerular Filtration Rate (eGFR) at Week 52 (Overall Cardiovascular Study) | Baseline and Week 52 | This change from baseline reflects the Week 52 eGFR minus the Week 0 eGFR. A negative number indicates a reduction in eGFR level. |
| Change From Baseline in Estimated Glomerular Filtration Rate (eGFR) at Month 24 (Overall Cardiovascular Study) | Baseline and Month 24 | This change from baseline reflects the Month 24 eGFR minus the Week 0 eGFR. A negative number indicates a reduction in the eGFR level. |
| Change From Baseline in Estimated Glomerular Filtration Rate (eGFR) at Month 36 (Overall Cardiovascular Study) | Baseline and Month 36 | This change from baseline reflects the Month 36 eGFR minus the Week 0 eGFR. A negative number indicates a reduction in the eGFR level. |
| Change From Baseline in Estimated Glomerular Filtration Rate (eGFR) at Month 48 (Overall Cardiovascular Study) | Baseline and Month 48 | This change from baseline reflects the Month 48 eGFR minus the Week 0 eGFR. A negative number indicates a reduction in eGFR level. |
| Change From Baseline in Estimated Glomerular Filtration Rate (eGFR) at Month 60 (Overall Cardiovascular Study) | Baseline and Month 60 | This change from baseline reflects the Month 60 eGFR minus the Week 0 eGFR. A negative number indicates a reduction in the eGFR level. |
| Change From Baseline in Estimated Glomerular Filtration Rate (eGFR) at Month 72 (Overall Cardiovascular Study) | Baseline and Month 72 | This change from baseline reflects the Month 72 eGFR minus the Week 0 eGFR. A negative number indicates a reduction in the eGFR level. |
| Baseline Serum Creatinine (Overall Cardiovascular Study) | Baseline | Baseline reflects Week 0 serum creatinine. |
| Change From Baseline in Serum Creatinine at Week 18 (Overall Cardiovascular Study) | Baseline and Week 18 | This change from baseline reflects the Week 18 serum creatinine minus the Week 0 serum creatinine. Participants who met glycemic rescue criteria received glycemic rescue medication. |
| Change From Baseline in Serum Creatinine at Week 52 (Overall Cardiovascular Study) | Baseline and Week 52 | This change from baseline reflects the Week 52 serum creatinine minus the Week 0 serum creatinine. Participants who met glycemic rescue criteria received glycemic rescue medication. |
| Change From Baseline in Serum Creatinine at Month 24 (Overall Cardiovascular Study) | Baseline and Month 24 | This change from baseline reflects the Month 24 serum creatinine minus the Week 0 serum creatinine. Participants who met glycemic rescue criteria received glycemic rescue medication. |
| Change From Baseline in Serum Creatinine at Month 36 (Overall Cardiovascular Study) | Baseline and Month 36 | This change from baseline reflects the Month 36 serum creatinine minus the Week 0 serum creatinine. Participants who met glycemic rescue criteria received glycemic rescue medication. |
| Change From Baseline in Serum Creatinine at Month 48 (Overall Cardiovascular Study) | Baseline and Month 48 | This change from baseline reflects the Month 48 serum creatinine minus the Week 0 serum creatinine. Participants who met glycemic rescue criteria received glycemic rescue medication. |
| Change From Baseline in Serum Creatinine at Month 60 (Overall Cardiovascular Study) | Baseline and Month 60 | This change from baseline reflects the Month 60 serum creatinine minus the Week 0 serum creatinine. Participants who met glycemic rescue criteria received glycemic rescue medication. |
| Change From Baseline in Serum Creatinine at Month 72 (Overall Cardiovascular Study) | Baseline and Month 72 | This change from baseline reflects the Month 72 serum creatinine minus the Week 0 serum creatinine. Participants who met glycemic rescue criteria received glycemic rescue medication. |
| Baseline Urinary Albumin/Creatinine Ratio (Overall Cardiovascular Study) | Baseline | Baseline reflects Week 0 albumin/creatinine ratio. |
| Percent Change From Baseline in Urinary Albumin/Creatinine Ratio at Week 18 (Overall Cardiovascular Study) | Baseline and Week 18 | This percent change relative to baseline reflects the Week 18 albumin/creatinine ratio minus the Week 0 albumin/creatinine ratio. This difference was divided by the baseline to obtain the percent change. A negative number indicates a reduction in the urinary albumin/creatinine ratio. Participants who met glycemic rescue criteria received glycemic rescue medication. |
| Percent Change From Baseline in Urinary Albumin/Creatinine Ratio at Week 52 (Overall Cardiovascular Study) | Baseline and Week 52 | This percent change relative to baseline reflects the Week 52 albumin/creatinine ratio minus the Week 0 albumin/creatinine ratio. This difference was divided by the baseline to obtain the percent change. A negative number indicates a reduction in the albumin/creatinine ratio. Participants who met glycemic rescue criteria received glycemic rescue medication. |
| Percent Change From Baseline in Urinary Albumin/Creatinine Ratio at Month 24 (Overall Cardiovascular Study) | Baseline and Month 24 | This percent change relative to baseline reflects the Month 24 albumin/creatinine ratio minus the Week 0 albumin/creatinine ratio. This difference was divided by the baseline to obtain the percent change. A negative number indicates a reduction in urinary albumin/creatinine ratio. Participants who met glycemic rescue criteria received glycemic rescue medication. |
| Percent Change From Baseline in Urinary Albumin/Creatinine Ratio at Month 36 (Overall Cardiovascular Study) | Baseline and Month 36 | This percent change relative to baseline reflects the Month 36 albumin/creatinine ratio minus the Week 0 albumin/creatinine ratio. This difference was divided by the baseline to obtain the percent change. A negative number indicates a reduction in urinary albumin/creatinine ratio. Participants who met glycemic rescue criteria received glycemic rescue medication. |
| Percent Change From Baseline in Urinary Albumin/Creatinine Ratio at Month 48 (Overall Cardiovascular Study) | Baseline and Month 48 | This percent change relative to baseline reflects the Month 48 albumin/creatinine ratio minus the Week 0 albumin/creatinine ratio. This difference was divided by the baseline to obtain the percent change. A negative number indicates a reduction in albumin/creatinine ratio. Participants who met glycemic rescue criteria received glycemic rescue medication. |
| Percent Change From Baseline in Urinary Albumin/Creatinine Ratio at Month 60 (Overall Cardiovascular Study) | Baseline and Month 60 | This percent change relative to baseline reflects the Month 60 albumin/creatinine ratio minus the Week 0 albumin/creatinine ratio. This difference was divided by the baseline to obtain the percent change. A negative number indicates a reduction in albumin/creatinine ratio. Participants who met glycemic rescue criteria received glycemic rescue medication. |
| Percentage of Participants With Albuminuria Progression or Regression at Week 18 (Overall Cardiovascular Study) | Week 18 | Albuminuria progression and regression were assessed relative to the baseline albuminuria category. Progression was defined as either a change from having normal-albuminuria at baseline to micro-albuminuria at the respective visit, or micro-albuminuria at baseline to macro-albuminuria at the respective visit, or normal albuminuria at baseline to macro-albuminuria at the respective visit. Regression was defined as either a change from having micro-albuminuria at baseline to normal albuminuria at the respective visit, or macro-albuminuria at baseline to micro-albuminuria at the respective visit, or macro-albuminuria at baseline to normal albuminuria at the respective visit. Normal albuminuria: urine albumin to urinary creatinine ratio (UACR) \<30 (mg/g); Micro-albuminuria: UACR ≥30 and ≤300 (mg/g); Macro-albuminuria: UACR\>300 (mg/g). |
| Percentage of Participants With Albuminuria Progression or Regression at Week 52 (Overall Cardiovascular Study) | Week 52 | Albuminuria progression and regression were assessed relative to the baseline albuminuria category. Progression was defined as either a change from having normal albuminuria at baseline to micro-albuminuria at the respective visit, or micro-albuminuria at baseline to macro-albuminuria at the respective visit, or normal albuminuria at baseline to macro-albuminuria at the respective visit. Regression was defined as either a change from having micro-albuminuria at baseline to normal albuminuria at the respective visit, or macro-albuminuria at baseline to micro-albuminuria at the respective visit, or macro-albuminuria at baseline to normal albuminuria at the respective visit. Normal albuminuria: urine albumin to urinary creatinine ratio (UACR) \<30 (mg/g); Micro-albuminuria: UACR ≥30 and ≤300 (mg/g); Macro-albuminuria: UACR\>300 (mg/g). |
| Percentage of Participants With Albuminuria Progression or Regression at Month 24 (Overall Cardiovascular Study) | Month 24 | Albuminuria progression and regression were assessed relative to the baseline albuminuria category. Progression was defined as either a change from having normal albuminuria at baseline to micro-albuminuria at the respective visit, or micro-albuminuria at baseline to macro-albuminuria at the respective visit, or normal albuminuria at baseline to macro-albuminuria at the respective visit. Regression was defined as either a change from having micro-albuminuria at baseline to normal albuminuria at the respective visit, or macro-albuminuria at baseline to micro-albuminuria at the respective visit, or macro-albuminuria at baseline to normal albuminuria at the respective visit. Normal albuminuria: urine albumin to urinary creatinine ratio (UACR) \<30 (mg/g); Micro-albuminuria: UACR ≥30 and ≤300 (mg/g); Macro-albuminuria: UACR\>300 (mg/g). |
| Percentage of Participants With Albuminuria Progression or Regression at Month 36 (Overall Cardiovascular Study) | Month 36 | Albuminuria progression and regression were assessed relative to the baseline albuminuria category. Progression was defined as either a change from having normal albuminuria at baseline to micro-albuminuria at the respective visit, or micro-albuminuria at baseline to macro-albuminuria at the respective visit, or normal albuminuria at baseline to macro-albuminuria at the respective visit. Regression was defined as either a change from having micro-albuminuria at baseline to normal albuminuria at the respective visit, or macro-albuminuria at baseline to micro-albuminuria at the respective visit, or macro-albuminuria at baseline to normal albuminuria at the respective visit. Normal albuminuria: urine albumin to urinary creatinine ratio (UACR) \<30 (mg/g); Micro-albuminuria: UACR ≥30 and ≤300 (mg/g); Macro-albuminuria: UACR\>300 (mg/g). |
| Percentage of Participants With Albuminuria Progression or Regression at Month 48 (Overall Cardiovascular Study) | Month 48 | Albuminuria progression and regression were assessed relative to the baseline albuminuria category. Progression was defined as either a change from having normal albuminuria at baseline to micro-albuminuria at the respective visit, or micro-albuminuria at baseline to macro-albuminuria at the respective visit, or normal albuminuria at baseline to macro-albuminuria at the respective visit. Regression was defined as either a change from having micro-albuminuria at baseline to normal albuminuria at the respective visit, or macro-albuminuria at baseline to micro-albuminuria at the respective visit, or macro-albuminuria at baseline and normal albuminuria at the respective visit. Normal albuminuria: urine albumin to urinary creatinine ratio (UACR) \<30 (mg/g); Micro-albuminuria: UACR ≥30 and ≤300 (mg/g); Macro-albuminuria: UACR\>300 (mg/g). |
| Percentage of Participants With Albuminuria Progression or Regression at Month 60 (Overall Cardiovascular Study) | Month 60 | Albuminuria progression and regression were assessed relative to the baseline albuminuria category. Progression was defined as either a change from having normal albuminuria at baseline to micro albuminuria at the respective visit, or micro-albuminuria at baseline to macro-albuminuria at the respective visit, or normal albuminuria at baseline to macro-albuminuria at the respective visit. Regression was defined as either a change from having micro-albuminuria at baseline to normal albuminuria at the respective visit, or macro-albuminuria at baseline to micro-albuminuria at the respective visit, or macro-albuminuria at baseline to normal albuminuria at the respective visit. Normal albuminuria: urine albumin to urinary creatinine ratio (UACR) \<30 (mg/g); Micro-albuminuria: UACR ≥30 and ≤300 (mg/g); Macro-albuminuria: UACR\>300 (mg/g). |
| Percentage of Participants Experiencing an Adverse Event (AE) (Overall Cardiovascular Study) | Up to approximately 6 years | An AE is defined as any unfavorable and unintended sign including an abnormal laboratory finding, symptom or disease associated with the use of a medical treatment or procedure, regardless of whether it is considered related to the medical treatment or procedure, that occurs during the course of the study. |
| Change From Baseline in Sitting Diastolic Blood Pressure (DBP) at Week 18 (Excluding Rescue Approach) (Insulin With or Without Metformin Add-on Glycemic Sub-study) | Baseline and Week 18 | This change from baseline reflects the Week 18 DBP minus the Week 0 BBP. A negative number indicates a reduction in DBP. Participants who met glycemic rescue criteria received glycemic rescue medication. Excluding Rescue excluded all data following the initiation of rescue in order to avoid the confounding influence of the rescue therapy. |
| Percentage of Participants Experiencing an Adverse Event (AE) (Insulin With or Without Metformin Add-on Glycemic Sub-study) | Up to 18 weeks | An AE is defined as any unfavorable and unintended sign including an abnormal laboratory finding, symptom or disease associated with the use of a medical treatment or procedure, regardless of whether it is considered related to the medical treatment or procedure, that occurs during the course of the study. |
| Percentage of Participants Experiencing an Adverse Event (AE) (Sulfonylurea Monotherapy Add-on Glycemic Sub-Study) | Up to 18 weeks | An AE is defined as any unfavorable and unintended sign including an abnormal laboratory finding, symptom or disease associated with the use of a medical treatment or procedure, regardless of whether it is considered related to the medical treatment or procedure, that occurs during the course of the study. |
| Percentage of Participants Experiencing an Adverse Event (AE) (Metformin With Sulfonylurea Add-on Glycemic Sub-study) | Up to 18 weeks | An AE is defined as any unfavorable and unintended sign including an abnormal laboratory finding, symptom or disease associated with the use of a medical treatment or procedure, regardless of whether it is considered related to the medical treatment or procedure, that occurs during the course of the study. |
| Percentage of Participants Discontinuing Study Treatment Due to An AE (Overall Cardiovascular Study) | Up to approximately 6 years | An AE is defined as any unfavorable and unintended sign including an abnormal laboratory finding, symptom or disease associated with the use of a medical treatment or procedure, regardless of whether it is considered related to the medical treatment or procedure, that occurs during the course of the study. |
| Percentage of Participants Discontinuing Study Treatment Due to An AE (Insulin With or Without Metformin Add-on Glycemic Sub-study) | Up to 18 weeks | An AE is defined as any unfavorable and unintended sign including an abnormal laboratory finding, symptom or disease associated with the use of a medical treatment or procedure, regardless of whether it is considered related to the medical treatment or procedure, that occurs during the course of the study. |
| Percentage of Participants Discontinuing Study Treatment Due to An AE (Sulfonylurea Monotherapy Add-on Glycemic Sub-Study) | Up to 18 weeks | An AE is defined as any unfavorable and unintended sign including an abnormal laboratory finding, symptom or disease associated with the use of a medical treatment or procedure, regardless of whether it is considered related to the medical treatment or procedure, that occurs during the course of the study. |
| Percentage of Participants Discontinuing Study Treatment Due to An AE (Metformin With Sulfonylurea Add-on Glycemic Sub-study) | Up to 18 weeks | An AE is defined as any unfavorable and unintended sign including an abnormal laboratory finding, symptom or disease associated with the use of a medical treatment or procedure, regardless of whether it is considered related to the medical treatment or procedure, that occurs during the course of the study. |
| Change From Baseline in Fasting Plasma Glucose (FPG) at Week 18 (Excluding Rescue Approach) (Insulin With or Without Metformin Add-on Glycemic Sub-study) | Baseline and Week 18 | FPG was analyzed after an overnight fast. This change from baseline reflects the Week 18 FPG minus the Week 0 FPG. A negative number indicates a reduction in the FPG. Participants who met glycemic rescue criteria received glycemic rescue medication. Excluding Rescue excluded all data following the initiation of rescue in order to avoid the confounding influence of the rescue therapy. |
| Change From Baseline in Body Weight at Week 18 (Excluding Rescue Approach) (Insulin With or Without Metformin Add-on Glycemic Sub-study) | Baseline and Week 18 | This change from baseline reflects the Week 18 body weight minus the Week 0 body weight. Participants who met glycemic rescue criteria received glycemic rescue medication. Excluding Rescue excluded all data following the initiation of rescue in order to avoid the confounding influence of the rescue therapy. |
| Percentage of Participants With an A1C <7% (<53 mmol/Mol) at Week 18 (Excluding Rescue Approach) (Insulin With or Without Metformin Add-on Glycemic Sub-study) | Week 18 | A1C is a blood marker used to report average blood glucose levels over prolonged periods of time and is reported as a percentage (%). A1C represents the percentage of glycated hemoglobin. Participants who met glycemic rescue criteria received glycemic rescue medication. Excluding Rescue excluded all data following the initiation of rescue in order to avoid the confounding influence of the rescue therapy. |
| Change From Baseline in Sitting Systolic Blood Pressure (SBP) at Week 18 (Excluding Rescue Approach) (Insulin With or Without Metformin Add-on Glycemic Sub-study) | Baseline and Week 18 | This change from baseline reflects the Week 18 SBP minus the Week 0 SBP. A negative number indicates a reduction in SBP. Participants who met glycemic rescue criteria received glycemic rescue medication. Excluding Rescue excluded all data following the initiation of rescue in order to avoid the confounding influence of the rescue therapy. |
| Baseline Insulin Dose for Participants Receiving Insulin at Baseline - (Insulin With or Without Metformin Add-on Glycemic Sub-study) | Baseline | Baseline reflects Week 0 insulin dose. |
| Change From Baseline at Week 18 in Insulin Dose for Participants Receiving Insulin at Baseline - Including Rescue Approach (Insulin With or Without Metformin Add-on Glycemic Sub-study) | Baseline and Week 18 | This change from baseline reflects the Week 18 insulin dose minus the Week 0 insulin dose. A negative number indicates a decrease in insulin dose. Participants who met glycemic rescue criteria received glycemic rescue medication. Including rescue, included data following the initiation of rescue therapy. |
| Change From Baseline in Fasting Plasma Glucose (FPG) at Week 18 (Excluding Rescue Approach) (Sulfonylurea Monotherapy Add-on Glycemic Sub-Study) | Baseline and Week 18 | FPG was analyzed after an overnight fast. This change from baseline reflects the Week 18 FPG minus the Week 0 FPG. A negative number indicates a reduction in FPG. Participants who met glycemic rescue criteria received glycemic rescue medication. Excluding Rescue excluded all data following the initiation of rescue in order to avoid the confounding influence of the rescue therapy. |
| Change From Baseline in A1C at Month 24 (Overall Cardiovascular Study) | Baseline and Month 24 | A1C is a blood marker used to report average blood glucose levels over prolonged periods of time and is reported as a percentage (%). A1C represents the percentage of glycated hemoglobin. This change from baseline reflects the Month 24 A1C minus the Week 0 A1C. A negative number indicates a reduction in A1C level. Participants who met glycemic rescue criteria received glycemic rescue medication. |
| Percentage of Participants With an A1C <7% (<53 mmol/Mol) at Week 18 (Excluding Rescue Approach) (Sulfonylurea Monotherapy Add-on Glycemic Sub-Study) | Week 18 | A1C is a blood marker used to report average blood glucose levels over prolonged periods of time and is reported as a percentage (%). A1C represents the percentage of glycated hemoglobin. Participants who met glycemic rescue criteria received glycemic rescue medication. Excluding Rescue excluded all data following the initiation of rescue in order to avoid the confounding influence of the rescue therapy. |
| Change From Baseline in Sitting Systolic Blood Pressure (SBP) at Week 18 (Excluding Rescue Approach) (Sulfonylurea Monotherapy Add-on Glycemic Sub-Study) | Baseline and Week 18 | This change from baseline reflects the Week 18 SBP minus the Week 0 SBP. A negative number indicates a reduction in SBP. Participants who met glycemic rescue criteria received glycemic rescue medication. Excluding Rescue excluded all data following the initiation of rescue in order to avoid the confounding influence of the rescue therapy. |
| Change From Baseline in Sitting Diastolic Blood (DBP) Pressure at Week 18 (Excluding Rescue Approach) (Sulfonylurea Monotherapy Add-on Glycemic Sub-Study) | Baseline and Week 18 | This change from baseline reflects the Week 18 DBP minus the Week 0 DBP. A negative number indicates a reduction in DBP. Participants who met glycemic rescue criteria received glycemic rescue medication. Excluding Rescue excluded all data following the initiation of rescue in order to avoid the confounding influence of the rescue therapy. |
| Change From Baseline in Fasting Plasma Glucose (FPG) at Week 18 (Excluding Rescue Approach) (Metformin With Sulfonylurea Add-on Glycemic Sub-study) | Baseline and Week 18 | FPG was analyzed after an overnight fast. This change from baseline reflects the Week 18 FPG minus the Week 0 FPG. A negative number indicates a reduction in FPG. Participants who met glycemic rescue criteria received glycemic rescue medication. Excluding Rescue excluded all data following the initiation of rescue in order to avoid the confounding influence of the rescue therapy. |
| Change From Baseline in Body Weight at Week 18 (Excluding Rescue Approach) (Metformin With Sulfonylurea Add-on Glycemic Sub-study) | Baseline and Week 18 | This change from baseline reflects the Week 18 body weight minus the Week 0 body weight. A negative number indicates a reduction in body weight. Participants who met glycemic rescue criteria received glycemic rescue medication. Excluding Rescue excluded all data following the initiation of rescue in order to avoid the confounding influence of the rescue therapy. |
| Percentage of Participants With an A1C <7% (<53 mmol/Mol) at Week 18 (Excluding Rescue Approach) (Metformin With Sulfonylurea Add-on Glycemic Sub-study) | Week 18 | A1C is a blood marker used to report average blood glucose levels over prolonged periods of time and is reported as a percentage (%). A1C represents the percentage of glycated hemoglobin. Participants who met glycemic rescue criteria received glycemic rescue medication. Excluding Rescue excluded all data following the initiation of rescue in order to avoid the confounding influence of the rescue therapy. |
| Change From Baseline in Sitting Systolic Blood Pressure (SBP) at Week 18 (Excluding Rescue Approach) (Metformin With Sulfonylurea Add-on Glycemic Sub-study) | Baseline and Week 18 | This change from baseline reflects the Week 18 SBP minus the Week 0 SBP. A negative number indicates a reduction in SBP. Participants who met glycemic rescue criteria received glycemic rescue medication. Excluding Rescue excluded all data following the initiation of rescue in order to avoid the confounding influence of the rescue therapy. |
| Change From Baseline in Sitting Diastolic Blood (DBP) Pressure at Week 18 (Excluding Rescue Approach) (Metformin With Sulfonylurea Add-on Glycemic Sub-study) | Baseline and Week 18 | This change from baseline reflects the Week 18 DBP minus the Week 0 DBP. A negative number indicates a reduction in DBP. Participants who met glycemic rescue criteria received glycemic rescue medication. Excluding Rescue excluded all data following the initiation of rescue in order to avoid the confounding influence of the rescue therapy. |
| Change From Baseline in Body Weight at Week 18 (Excluding Rescue Approach) (Sulfonylurea Monotherapy Add-on Glycemic Sub-Study) | Baseline and Week 18 | This change from baseline reflects the Week 18 body weight minus the Week 0 body weight. A negative number indicates a reduction in body weight. Participants who met glycemic rescue criteria received glycemic rescue medication. Excluding Rescue excluded all data following the initiation of rescue in order to avoid the confounding influence of the rescue therapy. |
| Time to Occurrence of Cardiovascular (CV) Death or Hospitalization for Heart Failure (HHF) (On-Study Approach) (Overall Cardiovascular Study) | Up to approximately 6 years | Time to the occurrence of any of the following adjudicated components of cardiovascular (CV) death (including fatal stroke and fatal myocardial infarction (MI)) or hospitalization for heart failure. The on-study approach included confirmed events that occurred between the randomization date and the on-study censor date. Person-years was calculated as the sum of participants' time to event or time to censoring (the earliest of participants' end of study date, death date, or last contact date). |
| Time to Occurrence of Cardiovascular Death (On-study Approach) (Overall Cardiovascular Study) | Up to approximately 6 years | Time to the occurrence of cardiovascular (CV) death (including fatal stroke and fatal myocardial infarction (MI)). The on-study approach included confirmed events that occurred between the randomization date and the on-study censor date. Person-years was calculated as the sum of participants' time to CV death or time to censoring (the earliest of participants' end of study date or date last known to be alive). |
| Time to First Occurrence of the Renal Composite: the Composite of Renal Death, Renal Dialysis/Transplant, or Doubling of Serum Creatinine From Baseline (On-Study Approach) (Overall Cardiovascular Study) | Up to approximately 6 years | Renal composite endpoint was defined as a composite of renal death, renal dialysis/transplant, or doubling of serum creatinine from baseline. The on-study approach included events that occurred between the randomization date and the on-study censor date. Person-years was calculated as the sum of participants' time to first event or time to censoring (the earliest of participants' end of study date, death date, or last contact date). The on-study approach included events that occurred between the randomization date and the on-study censor date. |
| Time to First Occurrence of MACE Plus (Composite Endpoint of Cardiovascular Death, Non-fatal Myocardial Infarction, Non-fatal Stroke or Hospitalization for Unstable Angina) (On-Study Approach) (Overall Cardiovascular Study) | Up to approximately 6 years | Time to the first occurrence of any of the following adjudicated components 4-point MACE: cardiovascular death (including fatal stroke and fatal myocardial infarction), non-fatal myocardial infarction, non-fatal stroke, and hospitalization for unstable angina pectoris. The on-study approach included confirmed events that occurred between the randomization date and the on-study censor date. Person-years was calculated as the sum of participants' time to first event or time to censoring (the earliest of participants' end of study date, death date, or last contact date). The on-study approach included events that occurred between the randomization date and the on-study censor date. |
| Time to First Occurrence of Fatal or Non-fatal Myocardial Infarction (On-Study Approach) (Overall Cardiovascular Study) | Up to approximately 6 years | Time to First Occurrence of Fatal or Non-fatal Myocardial Infarction. The on-study approach included confirmed events that occurred between the randomization date and the on-study censor date. Person-years was calculated as the sum of participants' time to first event or time to censoring (the earliest of participants' end of study date, death date, or last contact date). |
| Time to First Occurrence of Fatal or Non-fatal Stroke (FNF Stroke) (On-Study Approach) (Overall Cardiovascular Study) | Up to approximately 6 years | Time to the first occurrence of fatal and no-fatal stroke. The on-study approach included confirmed events that occurred between the randomization date and the on-study censor date. Person-years was calculated as the sum of participants' time to first event or time to censoring (the earliest of participants' end of study date, death date, or last contact date). The on-study approach included events that occurred between the randomization date and the on-study censor date. |
Participant flow
Recruitment details
This study included participants in 34 countries at 548 study centers (Overall Cardiovascular Study).
Participants by arm
| Arm | Count |
|---|---|
| Ertugliflozin 5 mg (Overall Cardiovascular Study) Ertugliflozin 5 mg, administered orally, once daily, for up to approximately 6 years | 2,752 |
| Ertugliflozin 15 mg (Overall Cardiovascular Study) Ertugliflozin 15 mg, administered orally, once daily, for up to approximately 6 years | 2,747 |
| Placebo (Overall Cardiovascular Study) Matching placebo to ertugliflozin administered orally, once daily, for up to approximately 6 years | 2,747 |
| Total | 8,246 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 | FG002 |
|---|---|---|---|---|
| Overall Study | Death | 228 | 233 | 247 |
| Overall Study | Lost to Follow-up | 51 | 44 | 55 |
| Overall Study | Other | 1 | 2 | 2 |
| Overall Study | Physician Decision | 7 | 4 | 6 |
| Overall Study | Study Site Terminated by Sponsor | 2 | 2 | 3 |
| Overall Study | Subject Moved | 0 | 1 | 0 |
| Overall Study | Withdrawal by Subject | 41 | 60 | 45 |
Baseline characteristics
| Characteristic | Ertugliflozin 15 mg (Overall Cardiovascular Study) | Placebo (Overall Cardiovascular Study) | Ertugliflozin 5 mg (Overall Cardiovascular Study) | Total |
|---|---|---|---|---|
| Age, Continuous | 64.4 Years STANDARD_DEVIATION 8 | 64.4 Years STANDARD_DEVIATION 8 | 64.3 Years STANDARD_DEVIATION 8.2 | 64.4 Years STANDARD_DEVIATION 8.1 |
| Body Weight | 91.6 Kilograms STANDARD_DEVIATION 18.6 | 91.9 Kilograms STANDARD_DEVIATION 18.3 | 91.9 Kilograms STANDARD_DEVIATION 18.4 | 91.8 Kilograms STANDARD_DEVIATION 18.4 |
| Estimated Glomerular Filtration Rate (eGFR) | 76.2 mL/min/1.73 m^2 STANDARD_DEVIATION 20.9 | 75.7 mL/min/1.73 m^2 STANDARD_DEVIATION 20.8 | 76.0 mL/min/1.73 m^2 STANDARD_DEVIATION 20.8 | 76.0 mL/min/1.73 m^2 STANDARD_DEVIATION 20.9 |
| Ethnicity (NIH/OMB) Hispanic or Latino | 347 Participants | 343 Participants | 353 Participants | 1043 Participants |
| Ethnicity (NIH/OMB) Not Hispanic or Latino | 2392 Participants | 2399 Participants | 2390 Participants | 7181 Participants |
| Ethnicity (NIH/OMB) Unknown or Not Reported | 8 Participants | 5 Participants | 9 Participants | 22 Participants |
| Fasting Plasma Glucose (FPG) | 174.8 mg/dL STANDARD_DEVIATION 51.6 | 173.6 mg/dL STANDARD_DEVIATION 49.4 | 176.1 mg/dL STANDARD_DEVIATION 52.5 | 174.8 mg/dL STANDARD_DEVIATION 51.2 |
| Hemoglobin A1C (A1C) | 8.2 A1C Percentage STANDARD_DEVIATION 1 | 8.2 A1C Percentage STANDARD_DEVIATION 0.9 | 8.3 A1C Percentage STANDARD_DEVIATION 1 | 8.2 A1C Percentage STANDARD_DEVIATION 1 |
| Race (NIH/OMB) American Indian or Alaska Native | 8 Participants | 17 Participants | 13 Participants | 38 Participants |
| Race (NIH/OMB) Asian | 149 Participants | 162 Participants | 187 Participants | 498 Participants |
| Race (NIH/OMB) Black or African American | 75 Participants | 69 Participants | 91 Participants | 235 Participants |
| Race (NIH/OMB) More than one race | 69 Participants | 70 Participants | 67 Participants | 206 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 10 Participants | 15 Participants | 4 Participants | 29 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) White | 2436 Participants | 2414 Participants | 2390 Participants | 7240 Participants |
| Sex: Female, Male Female | 832 Participants | 844 Participants | 801 Participants | 2477 Participants |
| Sex: Female, Male Male | 1915 Participants | 1903 Participants | 1951 Participants | 5769 Participants |
| Sitting Diastolic Blood Pressure (DBP) | 76.7 mmHg STANDARD_DEVIATION 8.2 | 76.4 mmHg STANDARD_DEVIATION 8.7 | 76.8 mmHg STANDARD_DEVIATION 8.5 | 76.6 mmHg STANDARD_DEVIATION 8.5 |
| Sitting Systolic Blood Pressure (SBP) | 133.2 mmHg STANDARD_DEVIATION 13.8 | 133.1 mmHg STANDARD_DEVIATION 13.9 | 133.7 mmHg STANDARD_DEVIATION 13.7 | 133.3 mmHg STANDARD_DEVIATION 13.8 |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk | EG002 affected / at risk | EG003 affected / at risk | EG004 affected / at risk | EG005 affected / at risk | EG006 affected / at risk | EG007 affected / at risk | EG008 affected / at risk | EG009 affected / at risk | EG010 affected / at risk | EG011 affected / at risk |
|---|---|---|---|---|---|---|---|---|---|---|---|---|
| deaths Total, all-cause mortality | 228 / 2,746 | 233 / 2,747 | 247 / 2,745 | 4 / 348 | 6 / 370 | 1 / 347 | 0 / 55 | 1 / 54 | 0 / 48 | 0 / 100 | 1 / 113 | 0 / 117 |
| other Total, other adverse events | 1,405 / 2,746 | 1,389 / 2,747 | 1,395 / 2,745 | 127 / 348 | 144 / 370 | 135 / 347 | 10 / 55 | 4 / 54 | 9 / 48 | 24 / 100 | 32 / 113 | 26 / 117 |
| serious Total, serious adverse events | 958 / 2,746 | 937 / 2,747 | 990 / 2,745 | 33 / 348 | 27 / 370 | 37 / 347 | 4 / 55 | 1 / 54 | 2 / 48 | 7 / 100 | 8 / 113 | 6 / 117 |
Outcome results
Primary
Baseline Hemoglobin A1C (A1C) (Insulin With or Without Metformin Add-on Glycemic Sub-study)
A1C is a blood marker used to report average blood glucose levels over prolonged periods of time and is reported as a percentage (%). A1C represents the percentage of glycated hemoglobin. This baseline reflects the Week 0 A1C.
Time frame: Baseline
Population: The analysis population included all participants who were randomized, participated in the Insulin +/- Metformin Glycemic Sub-study, and had a measurement of the analysis endpoint at Baseline.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Ertugliflozin 5 mg (Overall Cardiovascular Study) | Baseline Hemoglobin A1C (A1C) (Insulin With or Without Metformin Add-on Glycemic Sub-study) | 8.45 A1C Percentage | Standard Deviation 0.944 |
| Ertugliflozin 15 mg (Overall Cardiovascular Study) | Baseline Hemoglobin A1C (A1C) (Insulin With or Without Metformin Add-on Glycemic Sub-study) | 8.38 A1C Percentage | Standard Deviation 0.985 |
| Placebo (Overall Cardiovascular Study) | Baseline Hemoglobin A1C (A1C) (Insulin With or Without Metformin Add-on Glycemic Sub-study) | 8.39 A1C Percentage | Standard Deviation 0.928 |
Primary
Baseline Hemoglobin A1C (A1C) (Metformin With Sulfonylurea Add-on Glycemic Sub-study)
A1C is a blood marker used to report average blood glucose levels over prolonged periods of time and is reported as a percentage (%). A1C represents the percentage of glycated hemoglobin. This baseline reflects Week 0 A1C.
Time frame: Baseline
Population: The analysis population included all participants who were randomized, participated in the Metformin with Sulfonylurea Glycemic Sub-study, and had an assessment for the analysis endpoint at Baseline.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Ertugliflozin 5 mg (Overall Cardiovascular Study) | Baseline Hemoglobin A1C (A1C) (Metformin With Sulfonylurea Add-on Glycemic Sub-study) | 8.39 A1C Percentage | Standard Deviation 0.96 |
| Ertugliflozin 15 mg (Overall Cardiovascular Study) | Baseline Hemoglobin A1C (A1C) (Metformin With Sulfonylurea Add-on Glycemic Sub-study) | 8.30 A1C Percentage | Standard Deviation 0.963 |
| Placebo (Overall Cardiovascular Study) | Baseline Hemoglobin A1C (A1C) (Metformin With Sulfonylurea Add-on Glycemic Sub-study) | 8.27 A1C Percentage | Standard Deviation 0.994 |
Primary
Baseline Hemoglobin A1C (A1C) (Sulfonylurea Monotherapy Add-on Glycemic Sub-Study)
A1C is a blood marker used to report average blood glucose levels over prolonged periods of time and is reported as a percentage (%). A1C represents the percentage of glycated hemoglobin. This baseline reflects the Week 0 A1C.
Time frame: Baseline
Population: The analysis population included all participants who were randomized, participated in the Sulfonyl Monotherapy Glycemic Sub-study, and had a measurement of the analysis endpoint at Baseline.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Ertugliflozin 5 mg (Overall Cardiovascular Study) | Baseline Hemoglobin A1C (A1C) (Sulfonylurea Monotherapy Add-on Glycemic Sub-Study) | 8.27 A1C Percentage | Standard Deviation 0.999 |
| Ertugliflozin 15 mg (Overall Cardiovascular Study) | Baseline Hemoglobin A1C (A1C) (Sulfonylurea Monotherapy Add-on Glycemic Sub-Study) | 8.39 A1C Percentage | Standard Deviation 1.019 |
| Placebo (Overall Cardiovascular Study) | Baseline Hemoglobin A1C (A1C) (Sulfonylurea Monotherapy Add-on Glycemic Sub-Study) | 8.21 A1C Percentage | Standard Deviation 1.169 |
Primary
Change From Baseline in Hemoglobin A1C (A1C) at Week 18 - Excluding Rescue Approach (Insulin With or Without Metformin Add-on Glycemic Sub-study)
A1C is a blood marker used to report average blood glucose levels over prolonged periods of time and is reported as a percentage (%). A1C represents the percentage of glycated hemoglobin. This change from baseline reflects the Week 18 A1C minus the Week 0 A1C. A negative number indicates a reduction in A1C level. Participants who met glycemic rescue criteria received glycemic rescue medication. Excluding Rescue excluded all data following the initiation of rescue in order to avoid the confounding influence of the rescue therapy.
Time frame: Baseline and Week 18
Population: The analysis population included all participants who were randomized, participated in the Insulin +/- Metformin Glycemic Sub-study, received at least 1 dose of study medication, and had at least 1 measurement of the analysis endpoint for the specified timepoint(s) from Baseline to Week 18.
| Arm | Measure | Value (LEAST_SQUARES_MEAN) |
|---|---|---|
| Ertugliflozin 5 mg (Overall Cardiovascular Study) | Change From Baseline in Hemoglobin A1C (A1C) at Week 18 - Excluding Rescue Approach (Insulin With or Without Metformin Add-on Glycemic Sub-study) | -0.77 A1C Percentage |
| Ertugliflozin 15 mg (Overall Cardiovascular Study) | Change From Baseline in Hemoglobin A1C (A1C) at Week 18 - Excluding Rescue Approach (Insulin With or Without Metformin Add-on Glycemic Sub-study) | -0.84 A1C Percentage |
| Placebo (Overall Cardiovascular Study) | Change From Baseline in Hemoglobin A1C (A1C) at Week 18 - Excluding Rescue Approach (Insulin With or Without Metformin Add-on Glycemic Sub-study) | -0.19 A1C Percentage |
p-value: <0.00195% CI: [-0.78, -0.51]cLDA Model
p-value: <0.00195% CI: [-0.71, -0.44]Constrained longitudinal data analysis
Primary
Change From Baseline in Hemoglobin A1C (A1C) at Week 18 - Excluding Rescue Approach (Metformin With Sulfonylurea Add-on Glycemic Sub-study)
A1C is a blood marker used to report average blood glucose levels over prolonged periods of time and is reported as a percentage (%). A1C represents the percentage of glycated hemoglobin. This change from baseline reflects the Week 18 A1C minus the Week 0 A1C. A negative number indicates a reduction in A1C level. Participants who met glycemic rescue criteria received glycemic rescue medication. Excluding Rescue excluded all data following the initiation of rescue in order to avoid the confounding influence of the rescue therapy.
Time frame: Baseline and Week 18
Population: The analysis population included all participants who were randomized, participated in the Metformin with Sulfonylurea Glycemic Sub-study, received at least one dose of blinded study medication, and had at least one assessment for the analysis endpoint for the specified timepoint(s) at or after Baseline.
| Arm | Measure | Value (LEAST_SQUARES_MEAN) |
|---|---|---|
| Ertugliflozin 5 mg (Overall Cardiovascular Study) | Change From Baseline in Hemoglobin A1C (A1C) at Week 18 - Excluding Rescue Approach (Metformin With Sulfonylurea Add-on Glycemic Sub-study) | -0.89 A1C Percentage |
| Ertugliflozin 15 mg (Overall Cardiovascular Study) | Change From Baseline in Hemoglobin A1C (A1C) at Week 18 - Excluding Rescue Approach (Metformin With Sulfonylurea Add-on Glycemic Sub-study) | -0.98 A1C Percentage |
| Placebo (Overall Cardiovascular Study) | Change From Baseline in Hemoglobin A1C (A1C) at Week 18 - Excluding Rescue Approach (Metformin With Sulfonylurea Add-on Glycemic Sub-study) | -0.23 A1C Percentage |
p-value: <0.00195% CI: [-0.98, -0.53]cLDA Model
p-value: <0.00195% CI: [-0.89, -0.43]cLDA model
Primary
Change From Baseline in Hemoglobin A1C (A1C) at Week 18 - Excluding Rescue Approach (Sulfonylurea Monotherapy Add-on Glycemic Sub-Study)
A1C is a blood marker used to report average blood glucose levels over prolonged periods of time and is reported as a percentage (%). A1C represents the percentage of glycated hemoglobin. This change from baseline reflects the Week 18 A1C minus the Week 0 A1C. A negative number indicates a reduction in A1C level. Participants who met glycemic rescue criteria received glycemic rescue medication. Excluding Rescue excluded all data following the initiation of rescue in order to avoid the confounding influence of the rescue therapy.
Time frame: Baseline and Week 18
Population: The analysis population included all participants who were randomized, participated in the Sulfonyl Monotherapy Glycemic Sub-study, received at least 1 dose of study medication, and had at least 1 measurement of the analysis endpoint for the specified timepoint(s) at any time from Baseline to Week 18.
| Arm | Measure | Value (LEAST_SQUARES_MEAN) |
|---|---|---|
| Ertugliflozin 5 mg (Overall Cardiovascular Study) | Change From Baseline in Hemoglobin A1C (A1C) at Week 18 - Excluding Rescue Approach (Sulfonylurea Monotherapy Add-on Glycemic Sub-Study) | -0.91 A1C Percentage |
| Ertugliflozin 15 mg (Overall Cardiovascular Study) | Change From Baseline in Hemoglobin A1C (A1C) at Week 18 - Excluding Rescue Approach (Sulfonylurea Monotherapy Add-on Glycemic Sub-Study) | -0.78 A1C Percentage |
| Placebo (Overall Cardiovascular Study) | Change From Baseline in Hemoglobin A1C (A1C) at Week 18 - Excluding Rescue Approach (Sulfonylurea Monotherapy Add-on Glycemic Sub-Study) | -0.56 A1C Percentage |
p-value: 0.24795% CI: [-0.6, 0.16]cLDA Model
p-value: 0.06395% CI: [-0.72, 0.02]cLDA model
Primary
Time to First Occurrence of MACE (Composite Endpoint of Major Adverse Cardiovascular Events [Cardiovascular Death, Non-fatal Myocardial Infarction or Non-fatal Stroke]) (On-Treatment + 365-day Approach) (Overall Cardiovascular Study)
Time to the first occurrence of any of the following adjudicated components of the primary composite endpoint (3-point major adverse cardiovascular events (MACE)): cardiovascular (CV) death (including fatal stroke and fatal myocardial infarction (MI)), non-fatal MI, and non-fatal stroke. The on-treatment approach included confirmed events that occurred between the date of first dose of study medication and the on-treatment censor date. Person-years was calculated as the sum of participants' time to first event or time to censoring (the earliest of participants' end of study date, death date, last contact date, or 365 days after the last dose).
Time frame: Up to approximately 6 years
Population: The analysis population included all participants who were randomized into the study and who received at least 1 dose of study medication.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Ertugliflozin 5 mg (Overall Cardiovascular Study) | Time to First Occurrence of MACE (Composite Endpoint of Major Adverse Cardiovascular Events [Cardiovascular Death, Non-fatal Myocardial Infarction or Non-fatal Stroke]) (On-Treatment + 365-day Approach) (Overall Cardiovascular Study) | 3.64 Events per 100 Person-years |
| Ertugliflozin 15 mg (Overall Cardiovascular Study) | Time to First Occurrence of MACE (Composite Endpoint of Major Adverse Cardiovascular Events [Cardiovascular Death, Non-fatal Myocardial Infarction or Non-fatal Stroke]) (On-Treatment + 365-day Approach) (Overall Cardiovascular Study) | 4.16 Events per 100 Person-years |
| Placebo (Overall Cardiovascular Study) | Time to First Occurrence of MACE (Composite Endpoint of Major Adverse Cardiovascular Events [Cardiovascular Death, Non-fatal Myocardial Infarction or Non-fatal Stroke]) (On-Treatment + 365-day Approach) (Overall Cardiovascular Study) | 4.01 Events per 100 Person-years |
| All Ertugliflozin (Overall Cardiovascular Study) | Time to First Occurrence of MACE (Composite Endpoint of Major Adverse Cardiovascular Events [Cardiovascular Death, Non-fatal Myocardial Infarction or Non-fatal Stroke]) (On-Treatment + 365-day Approach) (Overall Cardiovascular Study) | 3.90 Events per 100 Person-years |
p-value: <0.00195.6% CI: [0.848, 1.114]Cox Proportional Hazards Model
p-value: 0.00295.6% CI: [0.887, 1.211]Cox Proportional Hazards Model
p-value: <0.00195.6% CI: [0.773, 1.065]Cox Proportional Hazards Model
Secondary
Andersen-Gill Model for All Cardiovascular Death (CV Death) or Hospitalizations for Heart Failure (HFF) (On-Study Approach) (Overall Cardiovascular Study)
All events (first and recurrent) of the composite of CV death and HHF were assessed using an Andersen-Gill model. Person-years were calculated as the sum of time from randomization to end of follow-up. The on-study approach included events that occurred between the randomization date and the on-study censor date.
Time frame: Up to approximately 6 years
Population: The analysis population included all randomized participants.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Ertugliflozin 5 mg (Overall Cardiovascular Study) | Andersen-Gill Model for All Cardiovascular Death (CV Death) or Hospitalizations for Heart Failure (HFF) (On-Study Approach) (Overall Cardiovascular Study) | 2.92 Events per 100 Person-years |
| Ertugliflozin 15 mg (Overall Cardiovascular Study) | Andersen-Gill Model for All Cardiovascular Death (CV Death) or Hospitalizations for Heart Failure (HFF) (On-Study Approach) (Overall Cardiovascular Study) | 2.71 Events per 100 Person-years |
| Placebo (Overall Cardiovascular Study) | Andersen-Gill Model for All Cardiovascular Death (CV Death) or Hospitalizations for Heart Failure (HFF) (On-Study Approach) (Overall Cardiovascular Study) | 3.42 Events per 100 Person-years |
| All Ertugliflozin (Overall Cardiovascular Study) | Andersen-Gill Model for All Cardiovascular Death (CV Death) or Hospitalizations for Heart Failure (HFF) (On-Study Approach) (Overall Cardiovascular Study) | 2.82 Events per 100 Person-years |
Comparison: Ertugliflozin vs Placebo, based on the Andersen-Gill model for the recurrent events at the end of study. The on-study approach included confirmed events that occurred between randomization date and the on-study censor date.95% CI: [0.716, 0.945]
95% CI: [0.673, 0.935]
95% CI: [0.725, 1.001]
Secondary
Andersen-Gill Model for Total MACE (On-Study Approach) (Overall Cardiovascular Study)
All events (first and recurrent) of the composite of MACE (3-point major adverse cardiovascular events: cardiovascular (CV) death (including fatal stroke and fatal myocardial infarction (MI)), non-fatal MI, and non-fatal stroke) were assessed using Andersen-Gill model. The on-study approach included events that occurred between the randomization date and the on-study censor date.
Time frame: Up to approximately 6 years
Population: The analysis population included all randomized participants.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Ertugliflozin 5 mg (Overall Cardiovascular Study) | Andersen-Gill Model for Total MACE (On-Study Approach) (Overall Cardiovascular Study) | 4.35 Events per 100 Person-years |
| Ertugliflozin 15 mg (Overall Cardiovascular Study) | Andersen-Gill Model for Total MACE (On-Study Approach) (Overall Cardiovascular Study) | 4.91 Events per 100 Person-years |
| Placebo (Overall Cardiovascular Study) | Andersen-Gill Model for Total MACE (On-Study Approach) (Overall Cardiovascular Study) | 4.59 Events per 100 Person-years |
| All Ertugliflozin (Overall Cardiovascular Study) | Andersen-Gill Model for Total MACE (On-Study Approach) (Overall Cardiovascular Study) | 4.63 Events per 100 Person-years |
95% CI: [0.898, 1.131]
95% CI: [0.937, 1.219]
95% CI: [0.828, 1.085]
Secondary
Baseline Insulin Dose for Participants Receiving Insulin at Baseline - (Insulin With or Without Metformin Add-on Glycemic Sub-study)
Baseline reflects Week 0 insulin dose.
Time frame: Baseline
Population: The analysis population included all participants who were randomized, participated in the Insulin +/- Metformin Glycemic Sub-study, and received insulin at baseline.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Ertugliflozin 5 mg (Overall Cardiovascular Study) | Baseline Insulin Dose for Participants Receiving Insulin at Baseline - (Insulin With or Without Metformin Add-on Glycemic Sub-study) | 70.76 Unit/day | Standard Deviation 44.15 |
| Ertugliflozin 15 mg (Overall Cardiovascular Study) | Baseline Insulin Dose for Participants Receiving Insulin at Baseline - (Insulin With or Without Metformin Add-on Glycemic Sub-study) | 67.29 Unit/day | Standard Deviation 41.23 |
| Placebo (Overall Cardiovascular Study) | Baseline Insulin Dose for Participants Receiving Insulin at Baseline - (Insulin With or Without Metformin Add-on Glycemic Sub-study) | 73.20 Unit/day | Standard Deviation 49.58 |
Secondary
Baseline Insulin Dose for Participants Who Were on Insulin at Baseline (Overall Cardiovascular Study)
Baseline reflects Week 0 insulin dose.
Time frame: Baseline
Population: The analysis population included all participants who were randomized and were treated with insulin at Baseline.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Ertugliflozin 5 mg (Overall Cardiovascular Study) | Baseline Insulin Dose for Participants Who Were on Insulin at Baseline (Overall Cardiovascular Study) | 63.82 Units/Day | Standard Deviation 48.11 |
| Ertugliflozin 15 mg (Overall Cardiovascular Study) | Baseline Insulin Dose for Participants Who Were on Insulin at Baseline (Overall Cardiovascular Study) | 62.15 Units/Day | Standard Deviation 44.46 |
| Placebo (Overall Cardiovascular Study) | Baseline Insulin Dose for Participants Who Were on Insulin at Baseline (Overall Cardiovascular Study) | 65.74 Units/Day | Standard Deviation 46.34 |
Secondary
Baseline Serum Creatinine (Overall Cardiovascular Study)
Baseline reflects Week 0 serum creatinine.
Time frame: Baseline
Population: The analysis population included all participants who were randomized and had a measurement for the analysis endpoint for the specified timepoint at Baseline.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Ertugliflozin 5 mg (Overall Cardiovascular Study) | Baseline Serum Creatinine (Overall Cardiovascular Study) | 0.992 mg/dL | Standard Deviation 0.278 |
| Ertugliflozin 15 mg (Overall Cardiovascular Study) | Baseline Serum Creatinine (Overall Cardiovascular Study) | 0.985 mg/dL | Standard Deviation 0.277 |
| Placebo (Overall Cardiovascular Study) | Baseline Serum Creatinine (Overall Cardiovascular Study) | 0.991 mg/dL | Standard Deviation 0.281 |
| All Ertugliflozin (Overall Cardiovascular Study) | Baseline Serum Creatinine (Overall Cardiovascular Study) | 0.998 mg/dL | Standard Deviation 0.278 |
Secondary
Baseline Urinary Albumin/Creatinine Ratio (Overall Cardiovascular Study)
Baseline reflects Week 0 albumin/creatinine ratio.
Time frame: Baseline
Population: The analysis population included all participants who were randomized and had a measurement for the analysis endpoint for the specified timepoint at baseline.
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| Ertugliflozin 5 mg (Overall Cardiovascular Study) | Baseline Urinary Albumin/Creatinine Ratio (Overall Cardiovascular Study) | 18.00 mg/g |
| Ertugliflozin 15 mg (Overall Cardiovascular Study) | Baseline Urinary Albumin/Creatinine Ratio (Overall Cardiovascular Study) | 19.00 mg/g |
| Placebo (Overall Cardiovascular Study) | Baseline Urinary Albumin/Creatinine Ratio (Overall Cardiovascular Study) | 19.00 mg/g |
Secondary
Change From Baseline at Week 18 in Insulin Dose for Participants Receiving Insulin at Baseline - Including Rescue Approach (Insulin With or Without Metformin Add-on Glycemic Sub-study)
This change from baseline reflects the Week 18 insulin dose minus the Week 0 insulin dose. A negative number indicates a decrease in insulin dose. Participants who met glycemic rescue criteria received glycemic rescue medication. Including rescue, included data following the initiation of rescue therapy.
Time frame: Baseline and Week 18
Population: The analysis population included all participants who were randomized, participated in the Insulin +/- Metformin Glycemic Sub-study, received at least one dose of study medication and had measurements of the analysis endpoint for the specified timepoint(s) both at Baseline and Week 18, and received insulin at baseline.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Ertugliflozin 5 mg (Overall Cardiovascular Study) | Change From Baseline at Week 18 in Insulin Dose for Participants Receiving Insulin at Baseline - Including Rescue Approach (Insulin With or Without Metformin Add-on Glycemic Sub-study) | -0.71 Unit/day | Standard Deviation 10.14 |
| Ertugliflozin 15 mg (Overall Cardiovascular Study) | Change From Baseline at Week 18 in Insulin Dose for Participants Receiving Insulin at Baseline - Including Rescue Approach (Insulin With or Without Metformin Add-on Glycemic Sub-study) | -2.14 Unit/day | Standard Deviation 10.23 |
| Placebo (Overall Cardiovascular Study) | Change From Baseline at Week 18 in Insulin Dose for Participants Receiving Insulin at Baseline - Including Rescue Approach (Insulin With or Without Metformin Add-on Glycemic Sub-study) | -0.29 Unit/day | Standard Deviation 11.49 |
Secondary
Change From Baseline in A1C at Month 24 (Overall Cardiovascular Study)
A1C is a blood marker used to report average blood glucose levels over prolonged periods of time and is reported as a percentage (%). A1C represents the percentage of glycated hemoglobin. This change from baseline reflects the Month 24 A1C minus the Week 0 A1C. A negative number indicates a reduction in A1C level. Participants who met glycemic rescue criteria received glycemic rescue medication.
Time frame: Baseline and Month 24
Population: The analysis population included all participants who were randomized, received at least one dose of blinded study medication, and had at least one assessment for the specified timepoint(s) at or after baseline.
| Arm | Measure | Value (LEAST_SQUARES_MEAN) |
|---|---|---|
| Ertugliflozin 5 mg (Overall Cardiovascular Study) | Change From Baseline in A1C at Month 24 (Overall Cardiovascular Study) | -0.48 A1C Percentage |
| Ertugliflozin 15 mg (Overall Cardiovascular Study) | Change From Baseline in A1C at Month 24 (Overall Cardiovascular Study) | -0.46 A1C Percentage |
| Placebo (Overall Cardiovascular Study) | Change From Baseline in A1C at Month 24 (Overall Cardiovascular Study) | -0.08 A1C Percentage |
p-value: <0.00195% CI: [-0.45, -0.3]Constrained longitudinal data analysis
p-value: <0.00195% CI: [-0.46, -0.32]cLDA
Secondary
Change From Baseline in A1C at Month 36 (Overall Cardiovascular Study)
A1C is a blood marker used to report average blood glucose levels over prolonged periods of time and is reported as a percentage (%). A1C represents the percentage of glycated hemoglobin. This change from baseline reflects the Month 36 A1C minus the Week 0 A1C. A negative number indicates a reduction in A1C level. Participants who met glycemic rescue criteria received glycemic rescue medication.
Time frame: Baseline and Month 36
Population: The analysis population included all participants who were randomized, received at least one dose of blinded study medication, and had a measurement for the analysis endpoint for the specified timepoint(s) at both baseline and Month 36.
| Arm | Measure | Value (MEAN) |
|---|---|---|
| Ertugliflozin 5 mg (Overall Cardiovascular Study) | Change From Baseline in A1C at Month 36 (Overall Cardiovascular Study) | -0.42 A1C Percentage |
| Ertugliflozin 15 mg (Overall Cardiovascular Study) | Change From Baseline in A1C at Month 36 (Overall Cardiovascular Study) | -0.38 A1C Percentage |
| Placebo (Overall Cardiovascular Study) | Change From Baseline in A1C at Month 36 (Overall Cardiovascular Study) | -0.04 A1C Percentage |
Secondary
Change From Baseline in A1C at Month 48 (Overall Cardiovascular Study)
A1C is a blood marker used to report average blood glucose levels over prolonged periods of time and is reported as a percentage (%). A1C represents the percentage of glycated hemoglobin. This change from baseline reflects the Month 48 A1C minus the Week 0 A1C. A negative number indicates a reduction in A1C level. Participants who met glycemic rescue criteria received glycemic rescue medication.
Time frame: Baseline and Month 48
Population: The analysis population included all participants who were randomized, received at least one dose of blinded study medication, and had at least one assessment for specified timepoint(s) at or after baseline.
| Arm | Measure | Value (LEAST_SQUARES_MEAN) |
|---|---|---|
| Ertugliflozin 5 mg (Overall Cardiovascular Study) | Change From Baseline in A1C at Month 48 (Overall Cardiovascular Study) | -0.22 A1C Percentage |
| Ertugliflozin 15 mg (Overall Cardiovascular Study) | Change From Baseline in A1C at Month 48 (Overall Cardiovascular Study) | -0.17 A1C Percentage |
| Placebo (Overall Cardiovascular Study) | Change From Baseline in A1C at Month 48 (Overall Cardiovascular Study) | 0.14 A1C Percentage |
p-value: 0.00195% CI: [-0.41, -0.21]cLDA
p-value: <0.00195% CI: [-0.46, -0.26]cLDA model
Secondary
Change From Baseline in A1C at Month 60 (Overall Cardiovascular Study)
A1C is a blood marker used to report average blood glucose levels over prolonged periods of time and is reported as a percentage (%). A1C represents the percentage of glycated hemoglobin. This change from baseline reflects the Month 60 A1C minus the Week 0 A1C. A negative number indicates a reduction in A1C level. Participants who met glycemic rescue criteria received glycemic rescue medication.
Time frame: Baseline and Month 60
Population: The analysis population included all participants who were randomized, received at least one dose of blinded study medication, and had a measurement for the analysis endpoint for the specified timepoint(s) at both baseline and Month 60.
| Arm | Measure | Value (MEAN) |
|---|---|---|
| Ertugliflozin 5 mg (Overall Cardiovascular Study) | Change From Baseline in A1C at Month 60 (Overall Cardiovascular Study) | -0.25 A1C Percentage |
| Ertugliflozin 15 mg (Overall Cardiovascular Study) | Change From Baseline in A1C at Month 60 (Overall Cardiovascular Study) | -0.28 A1C Percentage |
| Placebo (Overall Cardiovascular Study) | Change From Baseline in A1C at Month 60 (Overall Cardiovascular Study) | -0.10 A1C Percentage |
Secondary
Change From Baseline in A1C at Month 72 (Overall Cardiovascular Study)
A1C is blood marker used to report average blood glucose levels over prolonged periods of time and is reported as a percentage (%). A1C represents the percentage of glycated hemoglobin. This change from baseline reflects the Month 72 A1C minus the Week 0 A1C. A negative number indicates a reduction in A1C level. Participants who met glycemic rescue criteria received glycemic rescue medication.
Time frame: Baseline and Month 72
Population: The analysis population included all participants who were randomized, received at least one dose of blinded study medication, and had a measurement for the analysis endpoint for the specified timepoint(s) at both baseline and Month 72.
| Arm | Measure | Value (MEAN) |
|---|---|---|
| Ertugliflozin 5 mg (Overall Cardiovascular Study) | Change From Baseline in A1C at Month 72 (Overall Cardiovascular Study) | -0.35 A1C Percentage |
| Ertugliflozin 15 mg (Overall Cardiovascular Study) | Change From Baseline in A1C at Month 72 (Overall Cardiovascular Study) | -0.13 A1C Percentage |
| Placebo (Overall Cardiovascular Study) | Change From Baseline in A1C at Month 72 (Overall Cardiovascular Study) | 0.24 A1C Percentage |
Secondary
Change From Baseline in A1C at Week 52 (Overall Cardiovascular Study)
A1C is a blood marker used to report average blood glucose levels over prolonged periods of time and is reported as a percentage (%). A1C represents the percentage of glycated hemoglobin. This change from baseline reflects the Week 52 A1C minus the Week 0 A1C. A negative number indicates a reduction in A1C level. Participants who met glycemic rescue criteria received glycemic rescue medication.
Time frame: Baseline and Week 52
Population: The analysis population included all participants who were randomized, received at least one dose of blinded study medication, and had at least one assessment for the analysis endpoint for the specified timepoint(s) at or after baseline.
| Arm | Measure | Value (LEAST_SQUARES_MEAN) |
|---|---|---|
| Ertugliflozin 5 mg (Overall Cardiovascular Study) | Change From Baseline in A1C at Week 52 (Overall Cardiovascular Study) | -0.69 A1C Percentage |
| Ertugliflozin 15 mg (Overall Cardiovascular Study) | Change From Baseline in A1C at Week 52 (Overall Cardiovascular Study) | -0.67 A1C Percentage |
| Placebo (Overall Cardiovascular Study) | Change From Baseline in A1C at Week 52 (Overall Cardiovascular Study) | -0.19 A1C Percentage |
p-value: <0.00195% CI: [-0.54, -0.43]Constrained Longitudinal Data Analysis
p-value: <0.00195% CI: [-0.55, -0.45]Constrained Longitudinal Data Analysis
Secondary
Change From Baseline in Body Weight at Month 24 (Overall Cardiovascular Study)
This change from baseline reflects the Month 24 body weight minus the Week 0 body weight. A negative number indicates a reduction in body weight. Participants who met glycemic rescue criteria received glycemic rescue medication.
Time frame: Baseline and Month 24
Population: The analysis population included all participants who were randomized, received at least one dose of blinded study medication, and had at least one measurement for the analysis endpoint for the specified timepoint(s) at or after baseline.
| Arm | Measure | Value (LEAST_SQUARES_MEAN) |
|---|---|---|
| Ertugliflozin 5 mg (Overall Cardiovascular Study) | Change From Baseline in Body Weight at Month 24 (Overall Cardiovascular Study) | -2.75 Kilograms |
| Ertugliflozin 15 mg (Overall Cardiovascular Study) | Change From Baseline in Body Weight at Month 24 (Overall Cardiovascular Study) | -3.17 Kilograms |
| Placebo (Overall Cardiovascular Study) | Change From Baseline in Body Weight at Month 24 (Overall Cardiovascular Study) | -0.65 Kilograms |
p-value: <0.00195% CI: [-2.83, -2.22]cLDA
p-value: <0.00195% CI: [-2.39, -1.83]cLDA
Secondary
Change From Baseline in Body Weight at Month 36 (Overall Cardiovascular Study)
This change from baseline reflects the Month 36 body weight minus the Week 0 body weight. A negative number indicates a reduction in body weight. Participants who met glycemic rescue criteria received glycemic rescue medication.
Time frame: Baseline and Month 36
Population: The analysis population included all participants who were randomized, received at least one dose of blinded study medication, and have at least one measurement for the analysis endpoint for the specified timepoint(s) at both Baseline and Month 36.
| Arm | Measure | Value (MEAN) |
|---|---|---|
| Ertugliflozin 5 mg (Overall Cardiovascular Study) | Change From Baseline in Body Weight at Month 36 (Overall Cardiovascular Study) | -3.03 Kilograms |
| Ertugliflozin 15 mg (Overall Cardiovascular Study) | Change From Baseline in Body Weight at Month 36 (Overall Cardiovascular Study) | -3.41 Kilograms |
| Placebo (Overall Cardiovascular Study) | Change From Baseline in Body Weight at Month 36 (Overall Cardiovascular Study) | -0.98 Kilograms |
Secondary
Change From Baseline in Body Weight at Month 48 (Overall Cardiovascular Study)
This change from baseline reflects the Month 48 body weight minus the Week 0 body weight. A negative number indicates a reduction in body weight. Participants who met glycemic rescue criteria received glycemic rescue medication.
Time frame: Baseline and Month 48
Population: The analysis population included all participants who were randomized, received at least one dose of blinded study medication, and had at least one measurement for the analysis endpoint for the specified timepoint(s) at or after baseline).
| Arm | Measure | Value (LEAST_SQUARES_MEAN) |
|---|---|---|
| Ertugliflozin 5 mg (Overall Cardiovascular Study) | Change From Baseline in Body Weight at Month 48 (Overall Cardiovascular Study) | -3.39 Kilograms |
| Ertugliflozin 15 mg (Overall Cardiovascular Study) | Change From Baseline in Body Weight at Month 48 (Overall Cardiovascular Study) | -3.83 Kilograms |
| Placebo (Overall Cardiovascular Study) | Change From Baseline in Body Weight at Month 48 (Overall Cardiovascular Study) | -1.29 Kilograms |
p-value: <0.00195% CI: [-2.97, -2.1]cLDA
p-value: <0.00195% CI: [-2.52, -1.68]cLDA
Secondary
Change From Baseline in Body Weight at Month 60 (Overall Cardiovascular Study)
This change from baseline reflects the Month 60 body weight minus the Week 0 body weight. A negative number indicates a reduction in body weight. Participants who met glycemic rescue criteria received glycemic rescue medication.
Time frame: Baseline and Month 60
Population: The analysis population included all participants who were randomized, received at least one dose of blinded study medication, and had a measurement for the analysis endpoint for the specified timepoint(s) at both Baseline and Month 60.
| Arm | Measure | Value (MEAN) |
|---|---|---|
| Ertugliflozin 5 mg (Overall Cardiovascular Study) | Change From Baseline in Body Weight at Month 60 (Overall Cardiovascular Study) | -3.66 Kilograms |
| Ertugliflozin 15 mg (Overall Cardiovascular Study) | Change From Baseline in Body Weight at Month 60 (Overall Cardiovascular Study) | -4.58 Kilograms |
| Placebo (Overall Cardiovascular Study) | Change From Baseline in Body Weight at Month 60 (Overall Cardiovascular Study) | -1.21 Kilograms |
Secondary
Change From Baseline in Body Weight at Month 72 (Overall Cardiovascular Study)
This change from baseline reflects the Month 72 body weight minus the Week 0 body weight. A negative number indicates a reduction in body weight. Participants who met glycemic rescue criteria received glycemic rescue medication.
Time frame: Baseline and Month 72
Population: The analysis population included all participants who were randomized, received at least one dose of blinded study medication, and had a measurement for the analysis endpoint for the specified timepoint(s) at both Baseline and Month 72.
| Arm | Measure | Value (MEAN) |
|---|---|---|
| Ertugliflozin 5 mg (Overall Cardiovascular Study) | Change From Baseline in Body Weight at Month 72 (Overall Cardiovascular Study) | -4.18 Kilograms |
| Ertugliflozin 15 mg (Overall Cardiovascular Study) | Change From Baseline in Body Weight at Month 72 (Overall Cardiovascular Study) | -7.37 Kilograms |
| Placebo (Overall Cardiovascular Study) | Change From Baseline in Body Weight at Month 72 (Overall Cardiovascular Study) | -0.98 Kilograms |
Secondary
Change From Baseline in Body Weight at Week 18 (Excluding Rescue Approach) (Insulin With or Without Metformin Add-on Glycemic Sub-study)
This change from baseline reflects the Week 18 body weight minus the Week 0 body weight. Participants who met glycemic rescue criteria received glycemic rescue medication. Excluding Rescue excluded all data following the initiation of rescue in order to avoid the confounding influence of the rescue therapy.
Time frame: Baseline and Week 18
Population: The analysis population included all participants who were randomized, participated in the Insulin +/- Metformin Glycemic Sub-study, received at least one dose of study medication and had at least one measurement of the analysis endpoint for the specified timepoint(s) at any time from baseline to Week 18.
| Arm | Measure | Value (LEAST_SQUARES_MEAN) |
|---|---|---|
| Ertugliflozin 5 mg (Overall Cardiovascular Study) | Change From Baseline in Body Weight at Week 18 (Excluding Rescue Approach) (Insulin With or Without Metformin Add-on Glycemic Sub-study) | -1.87 Kilograms |
| Ertugliflozin 15 mg (Overall Cardiovascular Study) | Change From Baseline in Body Weight at Week 18 (Excluding Rescue Approach) (Insulin With or Without Metformin Add-on Glycemic Sub-study) | -2.13 Kilograms |
| Placebo (Overall Cardiovascular Study) | Change From Baseline in Body Weight at Week 18 (Excluding Rescue Approach) (Insulin With or Without Metformin Add-on Glycemic Sub-study) | -0.25 Kilograms |
p-value: <0.00195% CI: [-2.37, -1.13]cLDA
p-value: <0.00195% CI: [-2.12, -1.13]cLDA model
Secondary
Change From Baseline in Body Weight at Week 18 (Excluding Rescue Approach) (Metformin With Sulfonylurea Add-on Glycemic Sub-study)
This change from baseline reflects the Week 18 body weight minus the Week 0 body weight. A negative number indicates a reduction in body weight. Participants who met glycemic rescue criteria received glycemic rescue medication. Excluding Rescue excluded all data following the initiation of rescue in order to avoid the confounding influence of the rescue therapy.
Time frame: Baseline and Week 18
Population: The analysis population included all participants who were randomized, participated in the Metformin with Sulfonylurea Glycemic Sub-study, received at least one dose of study medication and had at least one measurement of the analysis endpoint for the specified timepoint(s) at any time from Baseline to Week 18.
| Arm | Measure | Value (LEAST_SQUARES_MEAN) |
|---|---|---|
| Ertugliflozin 5 mg (Overall Cardiovascular Study) | Change From Baseline in Body Weight at Week 18 (Excluding Rescue Approach) (Metformin With Sulfonylurea Add-on Glycemic Sub-study) | -2.04 Kilograms |
| Ertugliflozin 15 mg (Overall Cardiovascular Study) | Change From Baseline in Body Weight at Week 18 (Excluding Rescue Approach) (Metformin With Sulfonylurea Add-on Glycemic Sub-study) | -2.41 Kilograms |
| Placebo (Overall Cardiovascular Study) | Change From Baseline in Body Weight at Week 18 (Excluding Rescue Approach) (Metformin With Sulfonylurea Add-on Glycemic Sub-study) | -0.47 Kilograms |
p-value: <0.00195% CI: [-2.65, -1.24]cLDA
p-value: <0.00195% CI: [-2.3, -0.84]cLDA
Secondary
Change From Baseline in Body Weight at Week 18 (Excluding Rescue Approach) (Overall Cardiovascular Study)
This change from baseline reflects the Week 18 body weight minus the Week 0 body weight. A negative number indicates a reduction in body weight. Participants who met glycemic rescue criteria received glycemic rescue medication. Excluding Rescue excluded all data following the initiation of rescue in order to avoid the confounding influence of the rescue therapy.
Time frame: Baseline and Week 18
Population: The analysis population included all participants who were randomized, received at least one dose of blinded study medication, and have at least and had at least one measurement for the analysis endpoint for the specified timepoint(s) at or after Baseline.
| Arm | Measure | Value (LEAST_SQUARES_MEAN) |
|---|---|---|
| Ertugliflozin 5 mg (Overall Cardiovascular Study) | Change From Baseline in Body Weight at Week 18 (Excluding Rescue Approach) (Overall Cardiovascular Study) | -2.03 Kilograms |
| Ertugliflozin 15 mg (Overall Cardiovascular Study) | Change From Baseline in Body Weight at Week 18 (Excluding Rescue Approach) (Overall Cardiovascular Study) | -2.32 Kilograms |
| Placebo (Overall Cardiovascular Study) | Change From Baseline in Body Weight at Week 18 (Excluding Rescue Approach) (Overall Cardiovascular Study) | -0.40 Kilograms |
p-value: <0.00195% CI: [-2.07, -1.77]cLDA
p-value: <0.00195% CI: [-1.78, -1.47]cLDA
Secondary
Change From Baseline in Body Weight at Week 18 (Excluding Rescue Approach) (Sulfonylurea Monotherapy Add-on Glycemic Sub-Study)
This change from baseline reflects the Week 18 body weight minus the Week 0 body weight. A negative number indicates a reduction in body weight. Participants who met glycemic rescue criteria received glycemic rescue medication. Excluding Rescue excluded all data following the initiation of rescue in order to avoid the confounding influence of the rescue therapy.
Time frame: Baseline and Week 18
Population: The analysis population included all participants who were randomized, participated in the Sulfonylurea Monotherapy Glycemic Sub-study, received at least one dose of study medication and had at least one measurement of the analysis endpoint for the specified timepoint(s) at any time from baseline to Week 18.
| Arm | Measure | Value (LEAST_SQUARES_MEAN) |
|---|---|---|
| Ertugliflozin 5 mg (Overall Cardiovascular Study) | Change From Baseline in Body Weight at Week 18 (Excluding Rescue Approach) (Sulfonylurea Monotherapy Add-on Glycemic Sub-Study) | -1.75 Kilograms |
| Ertugliflozin 15 mg (Overall Cardiovascular Study) | Change From Baseline in Body Weight at Week 18 (Excluding Rescue Approach) (Sulfonylurea Monotherapy Add-on Glycemic Sub-Study) | -1.20 Kilograms |
| Placebo (Overall Cardiovascular Study) | Change From Baseline in Body Weight at Week 18 (Excluding Rescue Approach) (Sulfonylurea Monotherapy Add-on Glycemic Sub-Study) | -0.68 Kilograms |
p-value: 0.41895% CI: [-1.79, 0.75]cLDA
p-value: 0.09295% CI: [-2.32, 0.18]cLDA model
Secondary
Change From Baseline in Body Weight at Week 52 (Overall Cardiovascular Study)
This change from baseline reflects the Week 52 body weight minus the Week 0 body weight. A negative number indicates a reduction in body weight. Participants who met glycemic rescue criteria received glycemic rescue medication.
Time frame: Baseline and Week 52
Population: The analysis population included all participants who were randomized, received at least one dose of blinded study medication, and had at least one measurement for the analysis endpoint for the specified timepoint(s) at or after Baseline.
| Arm | Measure | Value (LEAST_SQUARES_MEAN) |
|---|---|---|
| Ertugliflozin 5 mg (Overall Cardiovascular Study) | Change From Baseline in Body Weight at Week 52 (Overall Cardiovascular Study) | -2.46 Kilograms |
| Ertugliflozin 15 mg (Overall Cardiovascular Study) | Change From Baseline in Body Weight at Week 52 (Overall Cardiovascular Study) | -2.84 Kilograms |
| Placebo (Overall Cardiovascular Study) | Change From Baseline in Body Weight at Week 52 (Overall Cardiovascular Study) | -0.39 Kilograms |
p-value: <0.00195% CI: [-2.67, -2.24]cLDA
p-value: <0.00195% CI: [-2.28, -1.86]cLDA
Secondary
Change From Baseline in Estimated Glomerular Filtration Rate (eGFR) at Month 24 (Overall Cardiovascular Study)
This change from baseline reflects the Month 24 eGFR minus the Week 0 eGFR. A negative number indicates a reduction in the eGFR level.
Time frame: Baseline and Month 24
Population: The analysis population included all participants who were randomized, received at least one dose of blinded study medication, and had a measurement for the analysis endpoint for the specified timepoint(s) at both Baseline at or after Baseline.
| Arm | Measure | Value (MEAN) |
|---|---|---|
| Ertugliflozin 5 mg (Overall Cardiovascular Study) | Change From Baseline in Estimated Glomerular Filtration Rate (eGFR) at Month 24 (Overall Cardiovascular Study) | -1.48 mL/min/1.73 m^2 |
| Ertugliflozin 15 mg (Overall Cardiovascular Study) | Change From Baseline in Estimated Glomerular Filtration Rate (eGFR) at Month 24 (Overall Cardiovascular Study) | -2.35 mL/min/1.73 m^2 |
| Placebo (Overall Cardiovascular Study) | Change From Baseline in Estimated Glomerular Filtration Rate (eGFR) at Month 24 (Overall Cardiovascular Study) | -2.60 mL/min/1.73 m^2 |
95% CI: [-0.59, 1.08]
95% CI: [0.28, 1.95]
Secondary
Change From Baseline in Estimated Glomerular Filtration Rate (eGFR) at Month 36 (Overall Cardiovascular Study)
This change from baseline reflects the Month 36 eGFR minus the Week 0 eGFR. A negative number indicates a reduction in the eGFR level.
Time frame: Baseline and Month 36
Population: The analysis population included all participants who were randomized, received at least one dose of blinded study medication, and had a measurement for the analysis endpoint for the specified timepoint(s) at both Baseline and Month 36.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Ertugliflozin 5 mg (Overall Cardiovascular Study) | Change From Baseline in Estimated Glomerular Filtration Rate (eGFR) at Month 36 (Overall Cardiovascular Study) | -2.4 mL/min/1.73 m^2 | Standard Deviation 14 |
| Ertugliflozin 15 mg (Overall Cardiovascular Study) | Change From Baseline in Estimated Glomerular Filtration Rate (eGFR) at Month 36 (Overall Cardiovascular Study) | -2.3 mL/min/1.73 m^2 | Standard Deviation 13.4 |
| Placebo (Overall Cardiovascular Study) | Change From Baseline in Estimated Glomerular Filtration Rate (eGFR) at Month 36 (Overall Cardiovascular Study) | -3.8 mL/min/1.73 m^2 | Standard Deviation 14.1 |
Secondary
Change From Baseline in Estimated Glomerular Filtration Rate (eGFR) at Month 48 (Overall Cardiovascular Study)
This change from baseline reflects the Month 48 eGFR minus the Week 0 eGFR. A negative number indicates a reduction in eGFR level.
Time frame: Baseline and Month 48
Population: The analysis population included all participants who were randomized, received at least one dose of blinded study medication, and had for the analysis endpoint for the specified timepoint(s) a Baseline measurement and at least one assessment at or after Baseline.
| Arm | Measure | Value (LEAST_SQUARES_MEAN) |
|---|---|---|
| Ertugliflozin 5 mg (Overall Cardiovascular Study) | Change From Baseline in Estimated Glomerular Filtration Rate (eGFR) at Month 48 (Overall Cardiovascular Study) | -2.75 mL/min/1.73 m^2 |
| Ertugliflozin 15 mg (Overall Cardiovascular Study) | Change From Baseline in Estimated Glomerular Filtration Rate (eGFR) at Month 48 (Overall Cardiovascular Study) | -2.93 mL/min/1.73 m^2 |
| Placebo (Overall Cardiovascular Study) | Change From Baseline in Estimated Glomerular Filtration Rate (eGFR) at Month 48 (Overall Cardiovascular Study) | -4.41 mL/min/1.73 m^2 |
95% CI: [0.31, 2.66]
95% CI: [0.49, 2.84]
Secondary
Change From Baseline in Estimated Glomerular Filtration Rate (eGFR) at Month 60 (Overall Cardiovascular Study)
This change from baseline reflects the Month 60 eGFR minus the Week 0 eGFR. A negative number indicates a reduction in the eGFR level.
Time frame: Baseline and Month 60
Population: The analysis population included all participants who were randomized, received at least one dose of blinded study medication, and had a measurement for the analysis endpoint for the specified timepoint(s) at both Baseline and Month 60.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Ertugliflozin 5 mg (Overall Cardiovascular Study) | Change From Baseline in Estimated Glomerular Filtration Rate (eGFR) at Month 60 (Overall Cardiovascular Study) | -2.4 mL/min/1.73 m^2 | Standard Deviation 15.4 |
| Ertugliflozin 15 mg (Overall Cardiovascular Study) | Change From Baseline in Estimated Glomerular Filtration Rate (eGFR) at Month 60 (Overall Cardiovascular Study) | -2.9 mL/min/1.73 m^2 | Standard Deviation 14.1 |
| Placebo (Overall Cardiovascular Study) | Change From Baseline in Estimated Glomerular Filtration Rate (eGFR) at Month 60 (Overall Cardiovascular Study) | -6.8 mL/min/1.73 m^2 | Standard Deviation 14.3 |
Secondary
Change From Baseline in Estimated Glomerular Filtration Rate (eGFR) at Month 72 (Overall Cardiovascular Study)
This change from baseline reflects the Month 72 eGFR minus the Week 0 eGFR. A negative number indicates a reduction in the eGFR level.
Time frame: Baseline and Month 72
Population: The analysis population included all participants who were randomized, received at least one dose of blinded study medication, and had a measurement for the analysis endpoint for the specified timepoint(s) at both Baseline and time point.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Ertugliflozin 5 mg (Overall Cardiovascular Study) | Change From Baseline in Estimated Glomerular Filtration Rate (eGFR) at Month 72 (Overall Cardiovascular Study) | 3.7 mL/min/1.73 m^2 | Standard Deviation 12.9 |
| Ertugliflozin 15 mg (Overall Cardiovascular Study) | Change From Baseline in Estimated Glomerular Filtration Rate (eGFR) at Month 72 (Overall Cardiovascular Study) | 0.2 mL/min/1.73 m^2 | Standard Deviation 12.2 |
| Placebo (Overall Cardiovascular Study) | Change From Baseline in Estimated Glomerular Filtration Rate (eGFR) at Month 72 (Overall Cardiovascular Study) | -1.8 mL/min/1.73 m^2 | Standard Deviation 14.1 |
Secondary
Change From Baseline in Estimated Glomerular Filtration Rate (eGFR) at Week 18 (Overall Cardiovascular Study)
This change from baseline reflects the Week 18 eGFR minus the Week 0 eGFR. A negative number indicates a reduction in the eGFR level.
Time frame: Baseline and Week 18
Population: The analysis population included all participants who were randomized, received at least one dose of blinded study medication, and at least one measurement for the analysis endpoint for the specified timepoint(s) at or after Baseline.
| Arm | Measure | Value (LEAST_SQUARES_MEAN) |
|---|---|---|
| Ertugliflozin 5 mg (Overall Cardiovascular Study) | Change From Baseline in Estimated Glomerular Filtration Rate (eGFR) at Week 18 (Overall Cardiovascular Study) | -1.22 mL/min/1.73 m^2 |
| Ertugliflozin 15 mg (Overall Cardiovascular Study) | Change From Baseline in Estimated Glomerular Filtration Rate (eGFR) at Week 18 (Overall Cardiovascular Study) | -1.81 mL/min/1.73 m^2 |
| Placebo (Overall Cardiovascular Study) | Change From Baseline in Estimated Glomerular Filtration Rate (eGFR) at Week 18 (Overall Cardiovascular Study) | -0.03 mL/min/1.73 m^2 |
95% CI: [-2.41, -1.15]
95% CI: [-1.82, -0.56]
Secondary
Change From Baseline in Estimated Glomerular Filtration Rate (eGFR) at Week 52 (Overall Cardiovascular Study)
This change from baseline reflects the Week 52 eGFR minus the Week 0 eGFR. A negative number indicates a reduction in eGFR level.
Time frame: Baseline and Week 52
Population: The analysis population included all participants who were randomized, received at least one dose of blinded study medication, and had for the analysis endpoint for the specified timepoint(s) a Baseline measurement and at least one measurement at or after Baseline.
| Arm | Measure | Value (LEAST_SQUARES_MEAN) |
|---|---|---|
| Ertugliflozin 5 mg (Overall Cardiovascular Study) | Change From Baseline in Estimated Glomerular Filtration Rate (eGFR) at Week 52 (Overall Cardiovascular Study) | -0.51 mL/min/1.73 m^2 |
| Ertugliflozin 15 mg (Overall Cardiovascular Study) | Change From Baseline in Estimated Glomerular Filtration Rate (eGFR) at Week 52 (Overall Cardiovascular Study) | -1.18 mL/min/1.73 m^2 |
| Placebo (Overall Cardiovascular Study) | Change From Baseline in Estimated Glomerular Filtration Rate (eGFR) at Week 52 (Overall Cardiovascular Study) | -0.30 mL/min/1.73 m^2 |
95% CI: [-1.58, -0.18]
95% CI: [-0.91, 0.49]
Secondary
Change From Baseline in Fasting Plasma Glucose (FPG) at Month 24 (Overall Cardiovascular Study)
FPG was analyzed after an overnight fast. This change from baseline reflects the Month 24 FPG minus the Week 0 FPG. A negative number indicates a reduction in FPG. Participants who met glycemic rescue criteria received glycemic rescue medication.
Time frame: Baseline and Month 24
Population: The analysis population included all participants who were randomized, received at least one dose of blinded study medication, and had a measurement for the analysis endpoint for the specified timepoint(s) at both Baseline and Month 24.
| Arm | Measure | Value (MEAN) |
|---|---|---|
| Ertugliflozin 5 mg (Overall Cardiovascular Study) | Change From Baseline in Fasting Plasma Glucose (FPG) at Month 24 (Overall Cardiovascular Study) | -22.09 mg/dL |
| Ertugliflozin 15 mg (Overall Cardiovascular Study) | Change From Baseline in Fasting Plasma Glucose (FPG) at Month 24 (Overall Cardiovascular Study) | -24.31 mg/dL |
| Placebo (Overall Cardiovascular Study) | Change From Baseline in Fasting Plasma Glucose (FPG) at Month 24 (Overall Cardiovascular Study) | -4.39 mg/dL |
Secondary
Change From Baseline in Fasting Plasma Glucose (FPG) at Month 36 (Overall Cardiovascular Study)
FPG was analyzed after an overnight fast. This change from baseline reflects the Month 36 FPG minus the Week 0 FPG. A negative number indicates a reduction in FPG. Participants who met glycemic rescue criteria received glycemic rescue medication.
Time frame: Baseline and Month 36
Population: The analysis population included all participants who were randomized, received at least one dose of blinded study medication, and had a measurement for the analysis endpoint for the specified timepoint(s) at both Baseline and Month 36.
| Arm | Measure | Value (MEAN) |
|---|---|---|
| Ertugliflozin 5 mg (Overall Cardiovascular Study) | Change From Baseline in Fasting Plasma Glucose (FPG) at Month 36 (Overall Cardiovascular Study) | -19.39 mg/dL |
| Ertugliflozin 15 mg (Overall Cardiovascular Study) | Change From Baseline in Fasting Plasma Glucose (FPG) at Month 36 (Overall Cardiovascular Study) | -22.59 mg/dL |
| Placebo (Overall Cardiovascular Study) | Change From Baseline in Fasting Plasma Glucose (FPG) at Month 36 (Overall Cardiovascular Study) | -3.63 mg/dL |
Secondary
Change From Baseline in Fasting Plasma Glucose (FPG) at Month 48 (Overall Cardiovascular Study)
FPG was analyzed after an overnight fast. This change from baseline reflects the Month 48 FPG minus the Week 0 FPG. A negative number indicates a reduction in FPG. Participants who met glycemic rescue criteria received glycemic rescue medication.
Time frame: Baseline and Month 48
Population: The analysis population included all participants who were randomized, received at least one dose of blinded study medication, and had a measurement for the analysis endpoint for the specified timepoint(s) at both Baseline and Month 48.
| Arm | Measure | Value (MEAN) |
|---|---|---|
| Ertugliflozin 5 mg (Overall Cardiovascular Study) | Change From Baseline in Fasting Plasma Glucose (FPG) at Month 48 (Overall Cardiovascular Study) | -15.28 mg/dL |
| Ertugliflozin 15 mg (Overall Cardiovascular Study) | Change From Baseline in Fasting Plasma Glucose (FPG) at Month 48 (Overall Cardiovascular Study) | -16.16 mg/dL |
| Placebo (Overall Cardiovascular Study) | Change From Baseline in Fasting Plasma Glucose (FPG) at Month 48 (Overall Cardiovascular Study) | 3.59 mg/dL |
Secondary
Change From Baseline in Fasting Plasma Glucose (FPG) at Month 60 (Overall Cardiovascular Study)
FPG was analyzed after an overnight fast. This change from baseline reflects the Month 60 FPG minus the Week 0 FPG. A negative number indicates a reduction in FPG. Participants who met glycemic rescue criteria received glycemic rescue medication.
Time frame: Baseline and Month 60
Population: The analysis population included all participants who were randomized, received at least one dose of blinded study medication, and had a measurement for the analysis endpoint for the specified timepoint(s) at both Baseline and Month 60.
| Arm | Measure | Value (MEAN) |
|---|---|---|
| Ertugliflozin 5 mg (Overall Cardiovascular Study) | Change From Baseline in Fasting Plasma Glucose (FPG) at Month 60 (Overall Cardiovascular Study) | -13.87 mg/dL |
| Ertugliflozin 15 mg (Overall Cardiovascular Study) | Change From Baseline in Fasting Plasma Glucose (FPG) at Month 60 (Overall Cardiovascular Study) | -11.15 mg/dL |
| Placebo (Overall Cardiovascular Study) | Change From Baseline in Fasting Plasma Glucose (FPG) at Month 60 (Overall Cardiovascular Study) | -4.69 mg/dL |
Secondary
Change From Baseline in Fasting Plasma Glucose (FPG) at Month 72 (Overall Cardiovascular Study)
FPG was analyzed after an overnight fast. This change from baseline reflects the Month 72 FPG minus the Week 0 FPG. A negative number indicates a reduction in FPG. Participants who met glycemic rescue criteria received glycemic rescue medication.
Time frame: Baseline and Month 72
Population: The analysis population included all participants who were randomized, received at least one dose of blinded study medication, and had a measurement for the analysis endpoint for the specified timepoint(s) at both baseline and Month 72.
| Arm | Measure | Value (MEAN) |
|---|---|---|
| Ertugliflozin 5 mg (Overall Cardiovascular Study) | Change From Baseline in Fasting Plasma Glucose (FPG) at Month 72 (Overall Cardiovascular Study) | -2.46 mg/dL |
| Ertugliflozin 15 mg (Overall Cardiovascular Study) | Change From Baseline in Fasting Plasma Glucose (FPG) at Month 72 (Overall Cardiovascular Study) | -84.83 mg/dL |
| Placebo (Overall Cardiovascular Study) | Change From Baseline in Fasting Plasma Glucose (FPG) at Month 72 (Overall Cardiovascular Study) | 14.56 mg/dL |
Secondary
Change From Baseline in Fasting Plasma Glucose (FPG) at Week 18 (Excluding Rescue Approach) (Insulin With or Without Metformin Add-on Glycemic Sub-study)
FPG was analyzed after an overnight fast. This change from baseline reflects the Week 18 FPG minus the Week 0 FPG. A negative number indicates a reduction in the FPG. Participants who met glycemic rescue criteria received glycemic rescue medication. Excluding Rescue excluded all data following the initiation of rescue in order to avoid the confounding influence of the rescue therapy.
Time frame: Baseline and Week 18
Population: The analysis population included all participants who were randomized, participated in the Insulin +/- Metformin Glycemic Sub-study, received at least one dose of blinded study medication, and had at least one measurement for the analysis endpoint for the specified timepoint(s) at or after Baseline.
| Arm | Measure | Value (LEAST_SQUARES_MEAN) |
|---|---|---|
| Ertugliflozin 5 mg (Overall Cardiovascular Study) | Change From Baseline in Fasting Plasma Glucose (FPG) at Week 18 (Excluding Rescue Approach) (Insulin With or Without Metformin Add-on Glycemic Sub-study) | -26.98 mg/dL |
| Ertugliflozin 15 mg (Overall Cardiovascular Study) | Change From Baseline in Fasting Plasma Glucose (FPG) at Week 18 (Excluding Rescue Approach) (Insulin With or Without Metformin Add-on Glycemic Sub-study) | -33.15 mg/dL |
| Placebo (Overall Cardiovascular Study) | Change From Baseline in Fasting Plasma Glucose (FPG) at Week 18 (Excluding Rescue Approach) (Insulin With or Without Metformin Add-on Glycemic Sub-study) | -7.74 mg/dL |
p-value: <0.00195% CI: [-32.84, -17.96]CLDA
p-value: <0.00195% CI: [-26.8, -11.68]cLDA
Secondary
Change From Baseline in Fasting Plasma Glucose (FPG) at Week 18 (Excluding Rescue Approach) (Metformin With Sulfonylurea Add-on Glycemic Sub-study)
FPG was analyzed after an overnight fast. This change from baseline reflects the Week 18 FPG minus the Week 0 FPG. A negative number indicates a reduction in FPG. Participants who met glycemic rescue criteria received glycemic rescue medication. Excluding Rescue excluded all data following the initiation of rescue in order to avoid the confounding influence of the rescue therapy.
Time frame: Baseline and Week 18
Population: The analysis population included all participants who were randomized, participated in the Metformin with Sulfonylurea Glycemic Sub-study, received at least one dose of study medication and had at least one measurement of the analysis endpoint for the specified timepoint(s) at any time from Baseline to Week 18.
| Arm | Measure | Value (LEAST_SQUARES_MEAN) |
|---|---|---|
| Ertugliflozin 5 mg (Overall Cardiovascular Study) | Change From Baseline in Fasting Plasma Glucose (FPG) at Week 18 (Excluding Rescue Approach) (Metformin With Sulfonylurea Add-on Glycemic Sub-study) | -35.28 mg/dL |
| Ertugliflozin 15 mg (Overall Cardiovascular Study) | Change From Baseline in Fasting Plasma Glucose (FPG) at Week 18 (Excluding Rescue Approach) (Metformin With Sulfonylurea Add-on Glycemic Sub-study) | -36.18 mg/dL |
| Placebo (Overall Cardiovascular Study) | Change From Baseline in Fasting Plasma Glucose (FPG) at Week 18 (Excluding Rescue Approach) (Metformin With Sulfonylurea Add-on Glycemic Sub-study) | -4.81 mg/dL |
p-value: <0.00195% CI: [-40.68, -22.07]CLDA
p-value: <0.00195% CI: [-40.23, -20.72]cLDA
Secondary
Change From Baseline in Fasting Plasma Glucose (FPG) at Week 18 (Excluding Rescue Approach) (Overall Cardiovascular Study)
FPG was analyzed after an overnight fast. This change from baseline reflects the Week 18 FPG minus the Week 0 FPG. A negative number indicates a reduction in FPG. Participants who met glycemic rescue criteria received glycemic rescue medication. Excluding rescue, excluded all data following the initiation of rescue in order to avoid the confounding influence of the rescue therapy.
Time frame: Baseline and Week 18
Population: The analysis population included all participants who were randomized, received at least one dose of blinded study medication, and had at least one measurement for the analysis endpoint for the specified timepoint(s) at or after Baseline.
| Arm | Measure | Value (LEAST_SQUARES_MEAN) |
|---|---|---|
| Ertugliflozin 5 mg (Overall Cardiovascular Study) | Change From Baseline in Fasting Plasma Glucose (FPG) at Week 18 (Excluding Rescue Approach) (Overall Cardiovascular Study) | -32.18 mg/dL |
| Ertugliflozin 15 mg (Overall Cardiovascular Study) | Change From Baseline in Fasting Plasma Glucose (FPG) at Week 18 (Excluding Rescue Approach) (Overall Cardiovascular Study) | -34.64 mg/dL |
| Placebo (Overall Cardiovascular Study) | Change From Baseline in Fasting Plasma Glucose (FPG) at Week 18 (Excluding Rescue Approach) (Overall Cardiovascular Study) | -17.08 mg/dL |
p-value: <0.00195% CI: [-19.49, -15.63]CLDA
p-value: <0.00195% CI: [-17.03, -13.17]cLDA
Secondary
Change From Baseline in Fasting Plasma Glucose (FPG) at Week 18 (Excluding Rescue Approach) (Sulfonylurea Monotherapy Add-on Glycemic Sub-Study)
FPG was analyzed after an overnight fast. This change from baseline reflects the Week 18 FPG minus the Week 0 FPG. A negative number indicates a reduction in FPG. Participants who met glycemic rescue criteria received glycemic rescue medication. Excluding Rescue excluded all data following the initiation of rescue in order to avoid the confounding influence of the rescue therapy.
Time frame: Baseline and Week 18
Population: The analysis population included all participants who were randomized, participated in the Sulfonylurea Monotherapy Glycemic Sub-study, received at least one dose of study medication and had at least one measurement of the analysis endpoint for the specified timepoint(s) at any time from baseline to Week 18.
| Arm | Measure | Value (LEAST_SQUARES_MEAN) |
|---|---|---|
| Ertugliflozin 5 mg (Overall Cardiovascular Study) | Change From Baseline in Fasting Plasma Glucose (FPG) at Week 18 (Excluding Rescue Approach) (Sulfonylurea Monotherapy Add-on Glycemic Sub-Study) | -28.28 mg/dL |
| Ertugliflozin 15 mg (Overall Cardiovascular Study) | Change From Baseline in Fasting Plasma Glucose (FPG) at Week 18 (Excluding Rescue Approach) (Sulfonylurea Monotherapy Add-on Glycemic Sub-Study) | -26.97 mg/dL |
| Placebo (Overall Cardiovascular Study) | Change From Baseline in Fasting Plasma Glucose (FPG) at Week 18 (Excluding Rescue Approach) (Sulfonylurea Monotherapy Add-on Glycemic Sub-Study) | -14.76 mg/dL |
p-value: 0.10595% CI: [-27.03, 2.06]cLDA
p-value: 0.06895% CI: [-28.06, 1]cLDA
Secondary
Change From Baseline in Fasting Plasma Glucose (FPG) at Week 52 (Overall Cardiovascular Study)
FPG was analyzed after an overnight fast. This change from baseline reflects the Week 52 FPG minus the Week 0 FPG. A negative number indicates a reduction in FPG. Participants who met glycemic rescue criteria received glycemic rescue medication.
Time frame: Baseline and Week 52
Population: The analysis population included all participants who were randomized, received at least one dose of blinded study medication, and had a measurement for the analysis endpoint for the specified timepoint(s) at both Baseline and Week 52.
| Arm | Measure | Value (MEAN) |
|---|---|---|
| Ertugliflozin 5 mg (Overall Cardiovascular Study) | Change From Baseline in Fasting Plasma Glucose (FPG) at Week 52 (Overall Cardiovascular Study) | -28.63 mg/dL |
| Ertugliflozin 15 mg (Overall Cardiovascular Study) | Change From Baseline in Fasting Plasma Glucose (FPG) at Week 52 (Overall Cardiovascular Study) | -28.97 mg/dL |
| Placebo (Overall Cardiovascular Study) | Change From Baseline in Fasting Plasma Glucose (FPG) at Week 52 (Overall Cardiovascular Study) | -8.76 mg/dL |
Secondary
Change From Baseline in Hemoglobin A1C (A1C) at Week 18 - Excluding Rescue Approach (Overall Cardiovascular Study)
A1C is a blood marker used to report average blood glucose levels over prolonged periods of time and is reported as a percentage (%). A1C represents the percentage of glycated hemoglobin. This change from baseline reflects the Week 18 A1C minus the Week 0 A1C. A negative number indicates a reduction in A1C level. Participants who met glycemic rescue criteria received glycemic rescue medication. Excluding Rescue excluded all data following the initiation of rescue in order to avoid the confounding influence of the rescue therapy.
Time frame: Baseline and Week 18
Population: The analysis population included all participants who were randomized, received at least one dose of blinded study medication, and had at least one assessment for the analysis endpoint for the specified timepoint(s) at or after baseline.
| Arm | Measure | Value (LEAST_SQUARES_MEAN) |
|---|---|---|
| Ertugliflozin 5 mg (Overall Cardiovascular Study) | Change From Baseline in Hemoglobin A1C (A1C) at Week 18 - Excluding Rescue Approach (Overall Cardiovascular Study) | -0.70 A1C Percentage |
| Ertugliflozin 15 mg (Overall Cardiovascular Study) | Change From Baseline in Hemoglobin A1C (A1C) at Week 18 - Excluding Rescue Approach (Overall Cardiovascular Study) | -0.72 A1C Percentage |
| Placebo (Overall Cardiovascular Study) | Change From Baseline in Hemoglobin A1C (A1C) at Week 18 - Excluding Rescue Approach (Overall Cardiovascular Study) | -0.22 A1C Percentage |
p-value: <0.00195% CI: [-0.55, -0.46]cLDA Model
p-value: <0.00195% CI: [-0.53, -0.44]cLDA model
Secondary
Change From Baseline in Insulin Dose at Month 24 for Participants Who Were on Insulin at Baseline (Overall Cardiovascular Study)
This change from baseline reflects the Month 24 insulin dose minus the Week 0 insulin dose. A negative number indicates a reduction in the insulin dose.
Time frame: Baseline and Month 24
Population: The analysis population included all participants who were randomized, received at least one dose of blinded study medication, were treated with insulin at Baseline, and had a measurement for the analysis endpoint for the specified timepoint(s) at both Baseline and Month 24.
| Arm | Measure | Value (MEAN) |
|---|---|---|
| Ertugliflozin 5 mg (Overall Cardiovascular Study) | Change From Baseline in Insulin Dose at Month 24 for Participants Who Were on Insulin at Baseline (Overall Cardiovascular Study) | 0.45 Units/Day |
| Ertugliflozin 15 mg (Overall Cardiovascular Study) | Change From Baseline in Insulin Dose at Month 24 for Participants Who Were on Insulin at Baseline (Overall Cardiovascular Study) | -1.58 Units/Day |
| Placebo (Overall Cardiovascular Study) | Change From Baseline in Insulin Dose at Month 24 for Participants Who Were on Insulin at Baseline (Overall Cardiovascular Study) | 6.16 Units/Day |
Secondary
Change From Baseline in Insulin Dose at Month 36 for Participants Who Were on Insulin at Baseline (Overall Cardiovascular Study)
This change from baseline reflects the Month 36 insulin dose minus the Week 0 insulin dose. A negative number indicates a reduction in the insulin dose.
Time frame: Baseline and Month 36
Population: The analysis population included all participants who were randomized, received at least one dose of blinded study medication, were treated with insulin at Baseline, and had a measurement for the analysis endpoint for the specified timepoint(s) at both Baseline and Month 36.
| Arm | Measure | Value (MEAN) |
|---|---|---|
| Ertugliflozin 5 mg (Overall Cardiovascular Study) | Change From Baseline in Insulin Dose at Month 36 for Participants Who Were on Insulin at Baseline (Overall Cardiovascular Study) | 1.64 Units/Day |
| Ertugliflozin 15 mg (Overall Cardiovascular Study) | Change From Baseline in Insulin Dose at Month 36 for Participants Who Were on Insulin at Baseline (Overall Cardiovascular Study) | -1.92 Units/Day |
| Placebo (Overall Cardiovascular Study) | Change From Baseline in Insulin Dose at Month 36 for Participants Who Were on Insulin at Baseline (Overall Cardiovascular Study) | 7.99 Units/Day |
Secondary
Change From Baseline in Insulin Dose at Month 48 for Participants Who Were on Insulin at Baseline (Overall Cardiovascular Study)
This change from baseline reflects the Month 48 insulin dose minus the Week 0 insulin dose. A negative number indicates a reduction in the insulin dose.
Time frame: Baseline and Month 48
Population: The analysis population included all participants who were randomized, received at least one dose of blinded study medication, were treated with insulin at Baseline, and had a measurement for the analysis endpoint for the specified timepoint(s) at both Baseline and Month 48.
| Arm | Measure | Value (MEAN) |
|---|---|---|
| Ertugliflozin 5 mg (Overall Cardiovascular Study) | Change From Baseline in Insulin Dose at Month 48 for Participants Who Were on Insulin at Baseline (Overall Cardiovascular Study) | 2.96 Units/Day |
| Ertugliflozin 15 mg (Overall Cardiovascular Study) | Change From Baseline in Insulin Dose at Month 48 for Participants Who Were on Insulin at Baseline (Overall Cardiovascular Study) | -1.87 Units/Day |
| Placebo (Overall Cardiovascular Study) | Change From Baseline in Insulin Dose at Month 48 for Participants Who Were on Insulin at Baseline (Overall Cardiovascular Study) | 7.28 Units/Day |
Secondary
Change From Baseline in Insulin Dose at Month 60 for Participants Who Were on Insulin at Baseline (Overall Cardiovascular Study)
This change from baseline reflects the Month 60 insulin dose minus the Week 0 insulin dose. A negative number indicates a reduction in the insulin dose.
Time frame: Baseline and Month 60
Population: The analysis population included all participants who were randomized, received at least one dose of blinded study medication, were treated with insulin at Baseline, and had a measurement for the analysis endpoint for the specified timepoint(s) at both Baseline and Month 60.
| Arm | Measure | Value (MEAN) |
|---|---|---|
| Ertugliflozin 5 mg (Overall Cardiovascular Study) | Change From Baseline in Insulin Dose at Month 60 for Participants Who Were on Insulin at Baseline (Overall Cardiovascular Study) | -2.47 Units/Day |
| Ertugliflozin 15 mg (Overall Cardiovascular Study) | Change From Baseline in Insulin Dose at Month 60 for Participants Who Were on Insulin at Baseline (Overall Cardiovascular Study) | -1.77 Units/Day |
| Placebo (Overall Cardiovascular Study) | Change From Baseline in Insulin Dose at Month 60 for Participants Who Were on Insulin at Baseline (Overall Cardiovascular Study) | 9.42 Units/Day |
Secondary
Change From Baseline in Insulin Dose at Week 18 for Participants Who Were on Insulin at Baseline (Overall Cardiovascular Study)
This change from baseline reflects the Week 18 insulin dose minus the Week 0 insulin dose. A negative number indicates a reduction in the insulin dose.
Time frame: Baseline and Week 18
Population: The analysis population included all participants who were randomized, received at least one dose of blinded study medication, were treated with insulin at Baseline, and had a measurement for the analysis endpoint for the specified timepoint(s) at both Baseline and Week 18.
| Arm | Measure | Value (MEAN) |
|---|---|---|
| Ertugliflozin 5 mg (Overall Cardiovascular Study) | Change From Baseline in Insulin Dose at Week 18 for Participants Who Were on Insulin at Baseline (Overall Cardiovascular Study) | 1.05 Units/Day |
| Ertugliflozin 15 mg (Overall Cardiovascular Study) | Change From Baseline in Insulin Dose at Week 18 for Participants Who Were on Insulin at Baseline (Overall Cardiovascular Study) | 0.81 Units/Day |
| Placebo (Overall Cardiovascular Study) | Change From Baseline in Insulin Dose at Week 18 for Participants Who Were on Insulin at Baseline (Overall Cardiovascular Study) | 3.71 Units/Day |
Secondary
Change From Baseline in Insulin Dose at Week 52 for Participants Who Were on Insulin at Baseline (Overall Cardiovascular Study)
This change from baseline reflects the Week 52 insulin dose minus the Week 0 insulin dose. A negative number indicates a reduction in the insulin dose.
Time frame: Baseline and Week 52
Population: The analysis population included all participants who were randomized, received at least one dose of blinded study medication, were treated with insulin at Baseline, and had a measurement for the analysis endpoint for the specified timepoint(s) at both Baseline and Week 52.
| Arm | Measure | Value (MEAN) |
|---|---|---|
| Ertugliflozin 5 mg (Overall Cardiovascular Study) | Change From Baseline in Insulin Dose at Week 52 for Participants Who Were on Insulin at Baseline (Overall Cardiovascular Study) | 0.84 Units/Day |
| Ertugliflozin 15 mg (Overall Cardiovascular Study) | Change From Baseline in Insulin Dose at Week 52 for Participants Who Were on Insulin at Baseline (Overall Cardiovascular Study) | -1.69 Units/Day |
| Placebo (Overall Cardiovascular Study) | Change From Baseline in Insulin Dose at Week 52 for Participants Who Were on Insulin at Baseline (Overall Cardiovascular Study) | 5.57 Units/Day |
Secondary
Change From Baseline in Serum Creatinine at Month 24 (Overall Cardiovascular Study)
This change from baseline reflects the Month 24 serum creatinine minus the Week 0 serum creatinine. Participants who met glycemic rescue criteria received glycemic rescue medication.
Time frame: Baseline and Month 24
Population: The analysis population included all participants who were randomized, received at least one dose of blinded study medication, and had a measurement for the analysis endpoint for the specified timepoint(s) at both Baseline and Month 24.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Ertugliflozin 5 mg (Overall Cardiovascular Study) | Change From Baseline in Serum Creatinine at Month 24 (Overall Cardiovascular Study) | 0.024 mg/dL | Standard Deviation 0.176 |
| Ertugliflozin 15 mg (Overall Cardiovascular Study) | Change From Baseline in Serum Creatinine at Month 24 (Overall Cardiovascular Study) | 0.035 mg/dL | Standard Deviation 0.187 |
| Placebo (Overall Cardiovascular Study) | Change From Baseline in Serum Creatinine at Month 24 (Overall Cardiovascular Study) | 0.034 mg/dL | Standard Deviation 0.197 |
Secondary
Change From Baseline in Serum Creatinine at Month 36 (Overall Cardiovascular Study)
This change from baseline reflects the Month 36 serum creatinine minus the Week 0 serum creatinine. Participants who met glycemic rescue criteria received glycemic rescue medication.
Time frame: Baseline and Month 36
Population: The analysis population included all participants who were randomized, received at least one dose of blinded study medication, and had a measurement for the analysis endpoint for the specified timepoint(s) at both Baseline and Month 36.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Ertugliflozin 5 mg (Overall Cardiovascular Study) | Change From Baseline in Serum Creatinine at Month 36 (Overall Cardiovascular Study) | 0.037 mg/dL | Standard Deviation 0.194 |
| Ertugliflozin 15 mg (Overall Cardiovascular Study) | Change From Baseline in Serum Creatinine at Month 36 (Overall Cardiovascular Study) | 0.035 mg/dL | Standard Deviation 0.188 |
| Placebo (Overall Cardiovascular Study) | Change From Baseline in Serum Creatinine at Month 36 (Overall Cardiovascular Study) | 0.049 mg/dL | Standard Deviation 0.194 |
Secondary
Change From Baseline in Serum Creatinine at Month 48 (Overall Cardiovascular Study)
This change from baseline reflects the Month 48 serum creatinine minus the Week 0 serum creatinine. Participants who met glycemic rescue criteria received glycemic rescue medication.
Time frame: Baseline and Month 48
Population: The analysis population included all participants who were randomized, received at least one dose of blinded study medication, and had a measurement for the analysis endpoint for the specified timepoint(s) at both Baseline and Month 48.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Ertugliflozin 5 mg (Overall Cardiovascular Study) | Change From Baseline in Serum Creatinine at Month 48 (Overall Cardiovascular Study) | 0.032 mg/dL | Standard Deviation 0.206 |
| Ertugliflozin 15 mg (Overall Cardiovascular Study) | Change From Baseline in Serum Creatinine at Month 48 (Overall Cardiovascular Study) | 0.036 mg/dL | Standard Deviation 0.196 |
| Placebo (Overall Cardiovascular Study) | Change From Baseline in Serum Creatinine at Month 48 (Overall Cardiovascular Study) | 0.059 mg/dL | Standard Deviation 0.21 |
Secondary
Change From Baseline in Serum Creatinine at Month 60 (Overall Cardiovascular Study)
This change from baseline reflects the Month 60 serum creatinine minus the Week 0 serum creatinine. Participants who met glycemic rescue criteria received glycemic rescue medication.
Time frame: Baseline and Month 60
Population: The analysis population included all participants who were randomized, received at least one dose of blinded study medication, and had a measurement for the analysis endpoint for the specified timepoint(s) at both Baseline and Month 60.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Ertugliflozin 5 mg (Overall Cardiovascular Study) | Change From Baseline in Serum Creatinine at Month 60 (Overall Cardiovascular Study) | 0.027 mg/dL | Standard Deviation 0.202 |
| Ertugliflozin 15 mg (Overall Cardiovascular Study) | Change From Baseline in Serum Creatinine at Month 60 (Overall Cardiovascular Study) | 0.042 mg/dL | Standard Deviation 0.216 |
| Placebo (Overall Cardiovascular Study) | Change From Baseline in Serum Creatinine at Month 60 (Overall Cardiovascular Study) | 0.098 mg/dL | Standard Deviation 0.248 |
Secondary
Change From Baseline in Serum Creatinine at Month 72 (Overall Cardiovascular Study)
This change from baseline reflects the Month 72 serum creatinine minus the Week 0 serum creatinine. Participants who met glycemic rescue criteria received glycemic rescue medication.
Time frame: Baseline and Month 72
Population: The analysis population included all participants who were randomized, received at least one dose of blinded study medication, and had a measurement for the analysis endpoint for the specified timepoint(s) at both Baseline and Month 72.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Ertugliflozin 5 mg (Overall Cardiovascular Study) | Change From Baseline in Serum Creatinine at Month 72 (Overall Cardiovascular Study) | -0.034 mg/dL | Standard Deviation 0.176 |
| Ertugliflozin 15 mg (Overall Cardiovascular Study) | Change From Baseline in Serum Creatinine at Month 72 (Overall Cardiovascular Study) | 0.001 mg/dL | Standard Deviation 0.12 |
| Placebo (Overall Cardiovascular Study) | Change From Baseline in Serum Creatinine at Month 72 (Overall Cardiovascular Study) | -0.013 mg/dL | Standard Deviation 0.162 |
Secondary
Change From Baseline in Serum Creatinine at Week 18 (Overall Cardiovascular Study)
This change from baseline reflects the Week 18 serum creatinine minus the Week 0 serum creatinine. Participants who met glycemic rescue criteria received glycemic rescue medication.
Time frame: Baseline and Week 18
Population: The analysis population included all participants who were randomized, received at least one dose of blinded study medication, and had a measurement for the analysis endpoint for the specified timepoint(s) at both Baseline and Week 18.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Ertugliflozin 5 mg (Overall Cardiovascular Study) | Change From Baseline in Serum Creatinine at Week 18 (Overall Cardiovascular Study) | 0.022 mg/dL | Standard Deviation 0.154 |
| Ertugliflozin 15 mg (Overall Cardiovascular Study) | Change From Baseline in Serum Creatinine at Week 18 (Overall Cardiovascular Study) | 0.032 mg/dL | Standard Deviation 0.148 |
| Placebo (Overall Cardiovascular Study) | Change From Baseline in Serum Creatinine at Week 18 (Overall Cardiovascular Study) | -0.002 mg/dL | Standard Deviation 0.138 |
Secondary
Change From Baseline in Serum Creatinine at Week 52 (Overall Cardiovascular Study)
This change from baseline reflects the Week 52 serum creatinine minus the Week 0 serum creatinine. Participants who met glycemic rescue criteria received glycemic rescue medication.
Time frame: Baseline and Week 52
Population: The analysis population included all participants who were randomized, received at least one dose of blinded study medication, and had a measurement for the analysis endpoint for the specified timepoint(s) at both Baseline and Week 52.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Ertugliflozin 5 mg (Overall Cardiovascular Study) | Change From Baseline in Serum Creatinine at Week 52 (Overall Cardiovascular Study) | 0.013 mg/dL | Standard Deviation 0.166 |
| Ertugliflozin 15 mg (Overall Cardiovascular Study) | Change From Baseline in Serum Creatinine at Week 52 (Overall Cardiovascular Study) | 0.023 mg/dL | Standard Deviation 0.163 |
| Placebo (Overall Cardiovascular Study) | Change From Baseline in Serum Creatinine at Week 52 (Overall Cardiovascular Study) | 0.004 mg/dL | Standard Deviation 0.156 |
Secondary
Change From Baseline in Sitting Diastolic Blood (DBP) Pressure at Week 18 (Excluding Rescue Approach) (Metformin With Sulfonylurea Add-on Glycemic Sub-study)
This change from baseline reflects the Week 18 DBP minus the Week 0 DBP. A negative number indicates a reduction in DBP. Participants who met glycemic rescue criteria received glycemic rescue medication. Excluding Rescue excluded all data following the initiation of rescue in order to avoid the confounding influence of the rescue therapy.
Time frame: Baseline and Week 18
Population: The analysis population included all participants who were randomized, participated in the Metformin with Sulfonylurea Glycemic Sub-study, received at least one dose of study medication and had at least one measurement of the analysis endpoint for the specified timepoint(s) at any time from Baseline to Week 18.
| Arm | Measure | Value (LEAST_SQUARES_MEAN) |
|---|---|---|
| Ertugliflozin 5 mg (Overall Cardiovascular Study) | Change From Baseline in Sitting Diastolic Blood (DBP) Pressure at Week 18 (Excluding Rescue Approach) (Metformin With Sulfonylurea Add-on Glycemic Sub-study) | -0.30 mmHg |
| Ertugliflozin 15 mg (Overall Cardiovascular Study) | Change From Baseline in Sitting Diastolic Blood (DBP) Pressure at Week 18 (Excluding Rescue Approach) (Metformin With Sulfonylurea Add-on Glycemic Sub-study) | -0.92 mmHg |
| Placebo (Overall Cardiovascular Study) | Change From Baseline in Sitting Diastolic Blood (DBP) Pressure at Week 18 (Excluding Rescue Approach) (Metformin With Sulfonylurea Add-on Glycemic Sub-study) | -0.24 mmHg |
p-value: 0.4995% CI: [-2.6, 1.25]cLDA
p-value: 0.95895% CI: [-2.07, 1.96]cLDA
Secondary
Change From Baseline in Sitting Diastolic Blood (DBP) Pressure at Week 18 (Excluding Rescue Approach) (Sulfonylurea Monotherapy Add-on Glycemic Sub-Study)
This change from baseline reflects the Week 18 DBP minus the Week 0 DBP. A negative number indicates a reduction in DBP. Participants who met glycemic rescue criteria received glycemic rescue medication. Excluding Rescue excluded all data following the initiation of rescue in order to avoid the confounding influence of the rescue therapy.
Time frame: Baseline and Week 18
Population: The analysis population included all participants who were randomized, participated in the Sulfonylurea Monotherapy Glycemic Sub-study, received at least one dose of study medication and had at least one measurement of the analysis endpoint for the specified timepoint(s) at any time from Baseline to Week 18.
| Arm | Measure | Value (LEAST_SQUARES_MEAN) |
|---|---|---|
| Ertugliflozin 5 mg (Overall Cardiovascular Study) | Change From Baseline in Sitting Diastolic Blood (DBP) Pressure at Week 18 (Excluding Rescue Approach) (Sulfonylurea Monotherapy Add-on Glycemic Sub-Study) | -1.18 mmHg |
| Ertugliflozin 15 mg (Overall Cardiovascular Study) | Change From Baseline in Sitting Diastolic Blood (DBP) Pressure at Week 18 (Excluding Rescue Approach) (Sulfonylurea Monotherapy Add-on Glycemic Sub-Study) | -0.93 mmHg |
| Placebo (Overall Cardiovascular Study) | Change From Baseline in Sitting Diastolic Blood (DBP) Pressure at Week 18 (Excluding Rescue Approach) (Sulfonylurea Monotherapy Add-on Glycemic Sub-Study) | -2.91 mmHg |
p-value: 0.17895% CI: [-0.91, 4.86]cLDA model
p-value: 0.2395% CI: [-1.11, 4.58]cLDA
Secondary
Change From Baseline in Sitting Diastolic Blood Pressure (DBP) at Month 24 (Overall Cardiovascular Study)
This change from baseline reflects the Month 24 DBP minus the Week 0 DBP. A negative number indicates a reduction in DBP. Participants who met glycemic rescue criteria received glycemic rescue medication.
Time frame: Baseline and Month 24
Population: The analysis population included all participants who were randomized, received at least one dose of blinded study medication, and had at least one measurement for the analysis endpoint for the specified timepoint(s) at or after baseline.
| Arm | Measure | Value (LEAST_SQUARES_MEAN) |
|---|---|---|
| Ertugliflozin 5 mg (Overall Cardiovascular Study) | Change From Baseline in Sitting Diastolic Blood Pressure (DBP) at Month 24 (Overall Cardiovascular Study) | -0.94 mmHg |
| Ertugliflozin 15 mg (Overall Cardiovascular Study) | Change From Baseline in Sitting Diastolic Blood Pressure (DBP) at Month 24 (Overall Cardiovascular Study) | -0.90 mmHg |
| Placebo (Overall Cardiovascular Study) | Change From Baseline in Sitting Diastolic Blood Pressure (DBP) at Month 24 (Overall Cardiovascular Study) | -0.23 mmHg |
p-value: 0.0195% CI: [-1.19, -0.16]cLDA
p-value: 0.00695% CI: [-1.22, -0.2]cLDA
Secondary
Change From Baseline in Sitting Diastolic Blood Pressure (DBP) at Month 36 (Overall Cardiovascular Study)
This change from baseline reflects the Month 36 DBP minus the Week 0 DBP. A negative number indicates a reduction in DBP. Participants who met glycemic rescue criteria received glycemic rescue medication.
Time frame: Baseline and Month 36
Population: The analysis population included all participants who were randomized, received at least one dose of blinded study medication, and had a measurement for the analysis endpoint for the specified timepoint(s) at both Baseline and Month 36.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Ertugliflozin 5 mg (Overall Cardiovascular Study) | Change From Baseline in Sitting Diastolic Blood Pressure (DBP) at Month 36 (Overall Cardiovascular Study) | -1.27 mmHg | Standard Deviation 8.94 |
| Ertugliflozin 15 mg (Overall Cardiovascular Study) | Change From Baseline in Sitting Diastolic Blood Pressure (DBP) at Month 36 (Overall Cardiovascular Study) | -0.92 mmHg | Standard Deviation 8.89 |
| Placebo (Overall Cardiovascular Study) | Change From Baseline in Sitting Diastolic Blood Pressure (DBP) at Month 36 (Overall Cardiovascular Study) | -0.22 mmHg | Standard Deviation 9.15 |
Secondary
Change From Baseline in Sitting Diastolic Blood Pressure (DBP) at Month 48 (Overall Cardiovascular Study)
This change from baseline reflects the Month 48 DBP minus the Week 0 DBP. A negative number indicates a reduction in DBP. Participants who met glycemic rescue criteria received glycemic rescue medication.
Time frame: Baseline and Month 48
Population: The analysis population included all participants who were randomized, received at least one dose of blinded study medication, and had a measurement for the analysis endpoint for the specified timepoint(s) at or after Baseline.
| Arm | Measure | Value (MEAN) |
|---|---|---|
| Ertugliflozin 5 mg (Overall Cardiovascular Study) | Change From Baseline in Sitting Diastolic Blood Pressure (DBP) at Month 48 (Overall Cardiovascular Study) | -1.45 mmHg |
| Ertugliflozin 15 mg (Overall Cardiovascular Study) | Change From Baseline in Sitting Diastolic Blood Pressure (DBP) at Month 48 (Overall Cardiovascular Study) | -1.42 mmHg |
| Placebo (Overall Cardiovascular Study) | Change From Baseline in Sitting Diastolic Blood Pressure (DBP) at Month 48 (Overall Cardiovascular Study) | -0.64 mmHg |
p-value: 0.02495% CI: [-1.46, -0.1]Constrained longitudinal data analysis
p-value: 0.0295% CI: [-1.48, -0.13]Constrained longitudinal data analysis
Secondary
Change From Baseline in Sitting Diastolic Blood Pressure (DBP) at Month 60 (Overall Cardiovascular Study)
This change from baseline reflects the Month 60 DBP minus the Week 0 DBP. A negative number indicates a reduction in DBP. Participants who met glycemic rescue criteria received glycemic rescue medication.
Time frame: Baseline and Month 60
Population: The analysis population included all participants who were randomized, received at least one dose of blinded study medication, and had a measurement for the analysis endpoint for the specified timepoint(s) at both Baseline and Month 60.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Ertugliflozin 5 mg (Overall Cardiovascular Study) | Change From Baseline in Sitting Diastolic Blood Pressure (DBP) at Month 60 (Overall Cardiovascular Study) | -1.82 mmHg | Standard Deviation 8.66 |
| Ertugliflozin 15 mg (Overall Cardiovascular Study) | Change From Baseline in Sitting Diastolic Blood Pressure (DBP) at Month 60 (Overall Cardiovascular Study) | -1.43 mmHg | Standard Deviation 9.36 |
| Placebo (Overall Cardiovascular Study) | Change From Baseline in Sitting Diastolic Blood Pressure (DBP) at Month 60 (Overall Cardiovascular Study) | -1.26 mmHg | Standard Deviation 9.38 |
Secondary
Change From Baseline in Sitting Diastolic Blood Pressure (DBP) at Month 72 (Overall Cardiovascular Study)
This change from baseline reflects the Month 72 DBP minus the Week 0 DBP. A negative number indicates a reduction in DBP. Participants who met glycemic rescue criteria received glycemic rescue medication.
Time frame: Baseline and Month 72
Population: The analysis population included all participants who were randomized, received at least one dose of blinded study medication, and had a measurement for the analysis endpoint for the specified timepoint(s) at both Baseline and time point.
| Arm | Measure | Value (MEAN) |
|---|---|---|
| Ertugliflozin 5 mg (Overall Cardiovascular Study) | Change From Baseline in Sitting Diastolic Blood Pressure (DBP) at Month 72 (Overall Cardiovascular Study) | -2.18 mmHg |
| Ertugliflozin 15 mg (Overall Cardiovascular Study) | Change From Baseline in Sitting Diastolic Blood Pressure (DBP) at Month 72 (Overall Cardiovascular Study) | 1.86 mmHg |
| Placebo (Overall Cardiovascular Study) | Change From Baseline in Sitting Diastolic Blood Pressure (DBP) at Month 72 (Overall Cardiovascular Study) | 7.29 mmHg |
Secondary
Change From Baseline in Sitting Diastolic Blood Pressure (DBP) at Week 18 (Excluding Rescue Approach) (Insulin With or Without Metformin Add-on Glycemic Sub-study)
This change from baseline reflects the Week 18 DBP minus the Week 0 BBP. A negative number indicates a reduction in DBP. Participants who met glycemic rescue criteria received glycemic rescue medication. Excluding Rescue excluded all data following the initiation of rescue in order to avoid the confounding influence of the rescue therapy.
Time frame: Baseline and Week 18
Population: The analysis population included all participants who were randomized, participated in the Insulin +/- Metformin Glycemic Sub-study, received at least one dose of study medication, and had at least one measurement for the analysis endpoint for the specified timepoint(s) at or after Baseline.
| Arm | Measure | Value (LEAST_SQUARES_MEAN) |
|---|---|---|
| Ertugliflozin 5 mg (Overall Cardiovascular Study) | Change From Baseline in Sitting Diastolic Blood Pressure (DBP) at Week 18 (Excluding Rescue Approach) (Insulin With or Without Metformin Add-on Glycemic Sub-study) | -0.86 mmHg |
| Ertugliflozin 15 mg (Overall Cardiovascular Study) | Change From Baseline in Sitting Diastolic Blood Pressure (DBP) at Week 18 (Excluding Rescue Approach) (Insulin With or Without Metformin Add-on Glycemic Sub-study) | -0.64 mmHg |
| Placebo (Overall Cardiovascular Study) | Change From Baseline in Sitting Diastolic Blood Pressure (DBP) at Week 18 (Excluding Rescue Approach) (Insulin With or Without Metformin Add-on Glycemic Sub-study) | -0.26 mmHg |
p-value: 0.53395% CI: [-1.56, 0.81]cLDA model
p-value: 0.32695% CI: [-1.81, 0.6]cLDA model
Secondary
Change From Baseline in Sitting Diastolic Blood Pressure (DBP) at Week 18 (Excluding Rescue Approach) (Overall Cardiovascular Study)
This change from baseline reflects the Week 18 DBP minus the Week 0 DBP. A negative number indicates a reduction in DBP. Participants who met glycemic rescue criteria received glycemic rescue medication. Excluding rescue, excluded all data following the initiation of rescue in order to avoid the confounding influence of the rescue therapy.
Time frame: Baseline and Week 18
Population: The analysis population included all participants who were randomized, received at least one dose of blinded study medication, and had at least one measurement for the analysis endpoint at or after Baseline.
| Arm | Measure | Value (LEAST_SQUARES_MEAN) |
|---|---|---|
| Ertugliflozin 5 mg (Overall Cardiovascular Study) | Change From Baseline in Sitting Diastolic Blood Pressure (DBP) at Week 18 (Excluding Rescue Approach) (Overall Cardiovascular Study) | -0.99 mmHg |
| Ertugliflozin 15 mg (Overall Cardiovascular Study) | Change From Baseline in Sitting Diastolic Blood Pressure (DBP) at Week 18 (Excluding Rescue Approach) (Overall Cardiovascular Study) | -1.08 mmHg |
| Placebo (Overall Cardiovascular Study) | Change From Baseline in Sitting Diastolic Blood Pressure (DBP) at Week 18 (Excluding Rescue Approach) (Overall Cardiovascular Study) | -0.12 mmHg |
p-value: <0.00195% CI: [-1.37, -0.56]cLDA
p-value: <0.00195% CI: [-1.28, -0.47]cLDA
Secondary
Change From Baseline in Sitting Diastolic Blood Pressure (DBP) at Week 52 (Overall Cardiovascular Study)
This change from baseline reflects the Week 52 DBP minus the Week 0 DBP. A negative number indicates a reduction in DBP. Participants who met glycemic rescue criteria received glycemic rescue medication.
Time frame: Baseline and Week 52
Population: The analysis population included all participants who were randomized, received at least one dose of blinded study medication, and had at least one measurement for the analysis endpoint for the specified timepoint(s) at or after Baseline.
| Arm | Measure | Value (LEAST_SQUARES_MEAN) |
|---|---|---|
| Ertugliflozin 5 mg (Overall Cardiovascular Study) | Change From Baseline in Sitting Diastolic Blood Pressure (DBP) at Week 52 (Overall Cardiovascular Study) | -0.97 mmHg |
| Ertugliflozin 15 mg (Overall Cardiovascular Study) | Change From Baseline in Sitting Diastolic Blood Pressure (DBP) at Week 52 (Overall Cardiovascular Study) | -0.95 mmHg |
| Placebo (Overall Cardiovascular Study) | Change From Baseline in Sitting Diastolic Blood Pressure (DBP) at Week 52 (Overall Cardiovascular Study) | -0.15 mmHg |
p-value: <0.00195% CI: [-1.22, -0.39]cLDA
p-value: <0.00195% CI: [-1.24, -0.41]cLDA
Secondary
Change From Baseline in Sitting Systolic Blood Pressure (SBP) at Month 24 (Overall Cardiovascular Study)
This change from baseline reflects the Month 24 SBP minus the Week 0 SBP. A negative number indicates a reduction in SBP. Participants who met glycemic rescue criteria received glycemic rescue medication.
Time frame: Baseline and Month 24
Population: The analysis population included all participants who were randomized, received at least one dose of blinded study medication, and had at least one measurement for the analysis endpoint for the specified timepoint(s) at or after Baseline.
| Arm | Measure | Value (LEAST_SQUARES_MEAN) |
|---|---|---|
| Ertugliflozin 5 mg (Overall Cardiovascular Study) | Change From Baseline in Sitting Systolic Blood Pressure (SBP) at Month 24 (Overall Cardiovascular Study) | -1.80 mmHg |
| Ertugliflozin 15 mg (Overall Cardiovascular Study) | Change From Baseline in Sitting Systolic Blood Pressure (SBP) at Month 24 (Overall Cardiovascular Study) | -1.82 mmHg |
| Placebo (Overall Cardiovascular Study) | Change From Baseline in Sitting Systolic Blood Pressure (SBP) at Month 24 (Overall Cardiovascular Study) | 0.90 mmHg |
p-value: <0.00195% CI: [-3.57, -1.86]cLDA
p-value: <0.00195% CI: [-3.56, -1.85]cLDA
Secondary
Change From Baseline in Sitting Systolic Blood Pressure (SBP) at Month 36 (Overall Cardiovascular Study)
This change from baseline reflects the Month 36 SBP minus the Week 0 SBP. A negative number indicates a reduction in SBP. Participants who met glycemic rescue criteria received glycemic rescue medication.
Time frame: Baseline and Month 36
Population: The analysis population included all participants who were randomized, received at least one dose of blinded study medication, and had a measurement for the analysis endpoint for the specified timepoint(s) at both Baseline and Month 36.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Ertugliflozin 5 mg (Overall Cardiovascular Study) | Change From Baseline in Sitting Systolic Blood Pressure (SBP) at Month 36 (Overall Cardiovascular Study) | -1.55 mmHg | Standard Deviation 14.56 |
| Ertugliflozin 15 mg (Overall Cardiovascular Study) | Change From Baseline in Sitting Systolic Blood Pressure (SBP) at Month 36 (Overall Cardiovascular Study) | -1.21 mmHg | Standard Deviation 15.05 |
| Placebo (Overall Cardiovascular Study) | Change From Baseline in Sitting Systolic Blood Pressure (SBP) at Month 36 (Overall Cardiovascular Study) | 0.84 mmHg | Standard Deviation 14.63 |
Secondary
Change From Baseline in Sitting Systolic Blood Pressure (SBP) at Month 48 (Overall Cardiovascular Study)
This change from baseline reflects the Month 48 SBP minus the Week 0 SBP. A negative number indicates a reduction in SBP. Participants who met glycemic rescue criteria received glycemic rescue medication.
Time frame: Baseline and Month 48
Population: The analysis population included all participants who were randomized, received at least one dose of blinded study medication, and had at least one measurement for the analysis endpoint for the specified timepoint(s) at or after Baseline.
| Arm | Measure | Value (LEAST_SQUARES_MEAN) |
|---|---|---|
| Ertugliflozin 5 mg (Overall Cardiovascular Study) | Change From Baseline in Sitting Systolic Blood Pressure (SBP) at Month 48 (Overall Cardiovascular Study) | -2.07 mmHg |
| Ertugliflozin 15 mg (Overall Cardiovascular Study) | Change From Baseline in Sitting Systolic Blood Pressure (SBP) at Month 48 (Overall Cardiovascular Study) | -2.26 mmHg |
| Placebo (Overall Cardiovascular Study) | Change From Baseline in Sitting Systolic Blood Pressure (SBP) at Month 48 (Overall Cardiovascular Study) | 0.53 mmHg |
p-value: <0.00195% CI: [-3.68, -1.52]cLDA
p-value: <0.00195% CI: [-3.87, -1.71]cLDA
Secondary
Change From Baseline in Sitting Systolic Blood Pressure (SBP) at Month 60 (Overall Cardiovascular Study)
This change from baseline reflects the Month 60 SBP minus the Week 0 SBP. A negative number indicates a reduction in SBP. Participants who met glycemic rescue criteria received glycemic rescue medication.
Time frame: Baseline and Month 60
Population: The analysis population included all participants who were randomized, received at least one dose of blinded study medication, and had a measurement for the analysis endpoint for the specified timepoint(s) at both Baseline and Month 60.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Ertugliflozin 5 mg (Overall Cardiovascular Study) | Change From Baseline in Sitting Systolic Blood Pressure (SBP) at Month 60 (Overall Cardiovascular Study) | -2.18 mmHg | Standard Deviation 15.39 |
| Ertugliflozin 15 mg (Overall Cardiovascular Study) | Change From Baseline in Sitting Systolic Blood Pressure (SBP) at Month 60 (Overall Cardiovascular Study) | -1.87 mmHg | Standard Deviation 15.01 |
| Placebo (Overall Cardiovascular Study) | Change From Baseline in Sitting Systolic Blood Pressure (SBP) at Month 60 (Overall Cardiovascular Study) | 0.62 mmHg | Standard Deviation 15.85 |
Secondary
Change From Baseline in Sitting Systolic Blood Pressure (SBP) at Month 72 (Overall Cardiovascular Study)
This change from baseline reflects the Month 72 SBP minus the Week 0 SBP. A negative number indicates a reduction in SBP. Participants who met glycemic rescue criteria received glycemic rescue medication.
Time frame: Baseline and Month 72
Population: The analysis population included all participants who were randomized, received at least one dose of blinded study medication, and had a measurement for the analysis endpoint for the specified timepoint(s) at both Baseline and Month 72.
| Arm | Measure | Value (MEAN) |
|---|---|---|
| Ertugliflozin 5 mg (Overall Cardiovascular Study) | Change From Baseline in Sitting Systolic Blood Pressure (SBP) at Month 72 (Overall Cardiovascular Study) | 1.28 mmHg |
| Ertugliflozin 15 mg (Overall Cardiovascular Study) | Change From Baseline in Sitting Systolic Blood Pressure (SBP) at Month 72 (Overall Cardiovascular Study) | -3.46 mmHg |
| Placebo (Overall Cardiovascular Study) | Change From Baseline in Sitting Systolic Blood Pressure (SBP) at Month 72 (Overall Cardiovascular Study) | 2.72 mmHg |
Secondary
Change From Baseline in Sitting Systolic Blood Pressure (SBP) at Week 18 (Excluding Rescue Approach) (Insulin With or Without Metformin Add-on Glycemic Sub-study)
This change from baseline reflects the Week 18 SBP minus the Week 0 SBP. A negative number indicates a reduction in SBP. Participants who met glycemic rescue criteria received glycemic rescue medication. Excluding Rescue excluded all data following the initiation of rescue in order to avoid the confounding influence of the rescue therapy.
Time frame: Baseline and Week 18
Population: The analysis population included all participants who were randomized, participated in the Insulin +/- Metformin Glycemic Sub-study, received at least one dose of study medication, and had at least one measurement for the analysis endpoint for the specified timepoint(s) at or after Baseline.
| Arm | Measure | Value (LEAST_SQUARES_MEAN) |
|---|---|---|
| Ertugliflozin 5 mg (Overall Cardiovascular Study) | Change From Baseline in Sitting Systolic Blood Pressure (SBP) at Week 18 (Excluding Rescue Approach) (Insulin With or Without Metformin Add-on Glycemic Sub-study) | -2.67 mmHg |
| Ertugliflozin 15 mg (Overall Cardiovascular Study) | Change From Baseline in Sitting Systolic Blood Pressure (SBP) at Week 18 (Excluding Rescue Approach) (Insulin With or Without Metformin Add-on Glycemic Sub-study) | -2.12 mmHg |
| Placebo (Overall Cardiovascular Study) | Change From Baseline in Sitting Systolic Blood Pressure (SBP) at Week 18 (Excluding Rescue Approach) (Insulin With or Without Metformin Add-on Glycemic Sub-study) | 0.20 mmHg |
p-value: 0.02595% CI: [-4.35, -0.3]cLDA
p-value: 0.00695% CI: [-4.94, -0.82]cLDA
Secondary
Change From Baseline in Sitting Systolic Blood Pressure (SBP) at Week 18 (Excluding Rescue Approach) (Metformin With Sulfonylurea Add-on Glycemic Sub-study)
This change from baseline reflects the Week 18 SBP minus the Week 0 SBP. A negative number indicates a reduction in SBP. Participants who met glycemic rescue criteria received glycemic rescue medication. Excluding Rescue excluded all data following the initiation of rescue in order to avoid the confounding influence of the rescue therapy.
Time frame: Baseline and Week 18
Population: The analysis population included all participants who were randomized, participated in the Metformin with Sulfonylurea Glycemic Sub-study, received at least one dose of study medication and had at least one measurement of the analysis endpoint for the specified timepoint(s) at any time from Baseline to Week 18.
| Arm | Measure | Value (LEAST_SQUARES_MEAN) |
|---|---|---|
| Ertugliflozin 5 mg (Overall Cardiovascular Study) | Change From Baseline in Sitting Systolic Blood Pressure (SBP) at Week 18 (Excluding Rescue Approach) (Metformin With Sulfonylurea Add-on Glycemic Sub-study) | -2.26 mmHg |
| Ertugliflozin 15 mg (Overall Cardiovascular Study) | Change From Baseline in Sitting Systolic Blood Pressure (SBP) at Week 18 (Excluding Rescue Approach) (Metformin With Sulfonylurea Add-on Glycemic Sub-study) | -1.54 mmHg |
| Placebo (Overall Cardiovascular Study) | Change From Baseline in Sitting Systolic Blood Pressure (SBP) at Week 18 (Excluding Rescue Approach) (Metformin With Sulfonylurea Add-on Glycemic Sub-study) | -0.70 mmHg |
p-value: 0.59795% CI: [-4, 2.3]cLDA
p-value: 0.35195% CI: [-4.87, 1.73]cLDA
Secondary
Change From Baseline in Sitting Systolic Blood Pressure (SBP) at Week 18 (Excluding Rescue Approach) (Overall Cardiovascular Study)
This change from baseline reflects the Week 18 SBP minus the Week 0 SBP. A negative number indicates a reduction in SBP. Participants who met glycemic rescue criteria received glycemic rescue medication. Excluding rescue, excluded all data following the initiation of rescue in order to avoid the confounding influence of the rescue therapy.
Time frame: Baseline and Week 18
Population: The analysis population included all participants who were randomized, received at least one dose of blinded study medication, and had at least one measurement for the analysis endpoint for the specified timepoint(s) at or after Baseline.
| Arm | Measure | Value (LEAST_SQUARES_MEAN) |
|---|---|---|
| Ertugliflozin 5 mg (Overall Cardiovascular Study) | Change From Baseline in Sitting Systolic Blood Pressure (SBP) at Week 18 (Excluding Rescue Approach) (Overall Cardiovascular Study) | -2.51 mmHg |
| Ertugliflozin 15 mg (Overall Cardiovascular Study) | Change From Baseline in Sitting Systolic Blood Pressure (SBP) at Week 18 (Excluding Rescue Approach) (Overall Cardiovascular Study) | -2.75 mmHg |
| Placebo (Overall Cardiovascular Study) | Change From Baseline in Sitting Systolic Blood Pressure (SBP) at Week 18 (Excluding Rescue Approach) (Overall Cardiovascular Study) | 0.03 mmHg |
p-value: <0.00195% CI: [-3.45, -2.1]cLDA
p-value: <0.00195% CI: [-3.21, -1.86]cLDA
Secondary
Change From Baseline in Sitting Systolic Blood Pressure (SBP) at Week 18 (Excluding Rescue Approach) (Sulfonylurea Monotherapy Add-on Glycemic Sub-Study)
This change from baseline reflects the Week 18 SBP minus the Week 0 SBP. A negative number indicates a reduction in SBP. Participants who met glycemic rescue criteria received glycemic rescue medication. Excluding Rescue excluded all data following the initiation of rescue in order to avoid the confounding influence of the rescue therapy.
Time frame: Baseline and Week 18
Population: The analysis population included all participants who were randomized, participated in the Sulfonylurea Monotherapy Glycemic Sub-study, received at least one dose of study medication and had at least one measurement of the analysis endpoint for the specified timepoint(s) at any time from Baseline to Week 18.
| Arm | Measure | Value (LEAST_SQUARES_MEAN) |
|---|---|---|
| Ertugliflozin 5 mg (Overall Cardiovascular Study) | Change From Baseline in Sitting Systolic Blood Pressure (SBP) at Week 18 (Excluding Rescue Approach) (Sulfonylurea Monotherapy Add-on Glycemic Sub-Study) | -0.72 mmHg |
| Ertugliflozin 15 mg (Overall Cardiovascular Study) | Change From Baseline in Sitting Systolic Blood Pressure (SBP) at Week 18 (Excluding Rescue Approach) (Sulfonylurea Monotherapy Add-on Glycemic Sub-Study) | -0.80 mmHg |
| Placebo (Overall Cardiovascular Study) | Change From Baseline in Sitting Systolic Blood Pressure (SBP) at Week 18 (Excluding Rescue Approach) (Sulfonylurea Monotherapy Add-on Glycemic Sub-Study) | -3.53 mmHg |
p-value: 0.25595% CI: [-2, 7.45]cLDA
p-value: 0.23595% CI: [-1.85, 7.48]cLDA
Secondary
Change From Baseline in Sitting Systolic Blood Pressure (SBP) at Week 52 (Overall Cardiovascular Study)
This change from baseline reflects the Week 52 sitting SBP minus the Week 0 SBP. A negative number indicates a reduction in SBP. Participants who met glycemic rescue criteria received glycemic rescue medication.
Time frame: Baseline and Week 52
Population: The analysis population included all participants who were randomized, received at least one dose of blinded study medication, and had at least one measurement for the analysis endpoint for the specified timepoint(s) at or after Baseline.
| Arm | Measure | Value (LEAST_SQUARES_MEAN) |
|---|---|---|
| Ertugliflozin 5 mg (Overall Cardiovascular Study) | Change From Baseline in Sitting Systolic Blood Pressure (SBP) at Week 52 (Overall Cardiovascular Study) | -1.84 mmHg |
| Ertugliflozin 15 mg (Overall Cardiovascular Study) | Change From Baseline in Sitting Systolic Blood Pressure (SBP) at Week 52 (Overall Cardiovascular Study) | -2.41 mmHg |
| Placebo (Overall Cardiovascular Study) | Change From Baseline in Sitting Systolic Blood Pressure (SBP) at Week 52 (Overall Cardiovascular Study) | 0.75 mmHg |
p-value: <0.00195% CI: [-3.85, -2.45]cLDA
p-value: <0.00195% CI: [-3.28, -1.89]cLDA
Secondary
Percentage of Participants Discontinuing Study Treatment Due to An AE (Insulin With or Without Metformin Add-on Glycemic Sub-study)
An AE is defined as any unfavorable and unintended sign including an abnormal laboratory finding, symptom or disease associated with the use of a medical treatment or procedure, regardless of whether it is considered related to the medical treatment or procedure, that occurs during the course of the study.
Time frame: Up to 18 weeks
Population: The analysis population included all participants who were randomized, participated in the Insulin +/- Metformin Glycemic Sub-study, and who received at least one dose of blinded study medication.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Ertugliflozin 5 mg (Overall Cardiovascular Study) | Percentage of Participants Discontinuing Study Treatment Due to An AE (Insulin With or Without Metformin Add-on Glycemic Sub-study) | 2.9 Percentage of Participants |
| Ertugliflozin 15 mg (Overall Cardiovascular Study) | Percentage of Participants Discontinuing Study Treatment Due to An AE (Insulin With or Without Metformin Add-on Glycemic Sub-study) | 3.8 Percentage of Participants |
| Placebo (Overall Cardiovascular Study) | Percentage of Participants Discontinuing Study Treatment Due to An AE (Insulin With or Without Metformin Add-on Glycemic Sub-study) | 3.7 Percentage of Participants |
95% CI: [-2.9, 3]
95% CI: [-4, 1.6]
Secondary
Percentage of Participants Discontinuing Study Treatment Due to An AE (Metformin With Sulfonylurea Add-on Glycemic Sub-study)
An AE is defined as any unfavorable and unintended sign including an abnormal laboratory finding, symptom or disease associated with the use of a medical treatment or procedure, regardless of whether it is considered related to the medical treatment or procedure, that occurs during the course of the study.
Time frame: Up to 18 weeks
Population: The analysis population included all participants who were randomized, participated in the Metformin with Sulfonylurea Glycemic Sub-study, and who received at least one dose of blinded study medication.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Ertugliflozin 5 mg (Overall Cardiovascular Study) | Percentage of Participants Discontinuing Study Treatment Due to An AE (Metformin With Sulfonylurea Add-on Glycemic Sub-study) | 0 Percentage of Participants |
| Ertugliflozin 15 mg (Overall Cardiovascular Study) | Percentage of Participants Discontinuing Study Treatment Due to An AE (Metformin With Sulfonylurea Add-on Glycemic Sub-study) | 2.7 Percentage of Participants |
| Placebo (Overall Cardiovascular Study) | Percentage of Participants Discontinuing Study Treatment Due to An AE (Metformin With Sulfonylurea Add-on Glycemic Sub-study) | 1.7 Percentage of Participants |
Secondary
Percentage of Participants Discontinuing Study Treatment Due to An AE (Overall Cardiovascular Study)
An AE is defined as any unfavorable and unintended sign including an abnormal laboratory finding, symptom or disease associated with the use of a medical treatment or procedure, regardless of whether it is considered related to the medical treatment or procedure, that occurs during the course of the study.
Time frame: Up to approximately 6 years
Population: The analysis population included all participants who were randomized and who received at least one dose of blinded study medication.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Ertugliflozin 5 mg (Overall Cardiovascular Study) | Percentage of Participants Discontinuing Study Treatment Due to An AE (Overall Cardiovascular Study) | 7.5 Percentage of Participants |
| Ertugliflozin 15 mg (Overall Cardiovascular Study) | Percentage of Participants Discontinuing Study Treatment Due to An AE (Overall Cardiovascular Study) | 7.3 Percentage of Participants |
| Placebo (Overall Cardiovascular Study) | Percentage of Participants Discontinuing Study Treatment Due to An AE (Overall Cardiovascular Study) | 6.8 Percentage of Participants |
Secondary
Percentage of Participants Discontinuing Study Treatment Due to An AE (Sulfonylurea Monotherapy Add-on Glycemic Sub-Study)
An AE is defined as any unfavorable and unintended sign including an abnormal laboratory finding, symptom or disease associated with the use of a medical treatment or procedure, regardless of whether it is considered related to the medical treatment or procedure, that occurs during the course of the study.
Time frame: Up to 18 weeks
Population: The analysis population included all participants who were randomized, participated in the Sulfonylurea Monotherapy Glycemic Sub-study, and who received at least one dose of blinded study medication.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Ertugliflozin 5 mg (Overall Cardiovascular Study) | Percentage of Participants Discontinuing Study Treatment Due to An AE (Sulfonylurea Monotherapy Add-on Glycemic Sub-Study) | 3.6 Percentage of Participants |
| Ertugliflozin 15 mg (Overall Cardiovascular Study) | Percentage of Participants Discontinuing Study Treatment Due to An AE (Sulfonylurea Monotherapy Add-on Glycemic Sub-Study) | 1.9 Percentage of Participants |
| Placebo (Overall Cardiovascular Study) | Percentage of Participants Discontinuing Study Treatment Due to An AE (Sulfonylurea Monotherapy Add-on Glycemic Sub-Study) | 2.1 Percentage of Participants |
Secondary
Percentage of Participants Experiencing an Adverse Event (AE) (Insulin With or Without Metformin Add-on Glycemic Sub-study)
An AE is defined as any unfavorable and unintended sign including an abnormal laboratory finding, symptom or disease associated with the use of a medical treatment or procedure, regardless of whether it is considered related to the medical treatment or procedure, that occurs during the course of the study.
Time frame: Up to 18 weeks
Population: The analysis population included all participants who were randomized, participated in the Insulin +/- Metformin Glycemic Sub-study, and who received at least one dose of blinded study medication.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Ertugliflozin 5 mg (Overall Cardiovascular Study) | Percentage of Participants Experiencing an Adverse Event (AE) (Insulin With or Without Metformin Add-on Glycemic Sub-study) | 59.2 Percentage of Participants |
| Ertugliflozin 15 mg (Overall Cardiovascular Study) | Percentage of Participants Experiencing an Adverse Event (AE) (Insulin With or Without Metformin Add-on Glycemic Sub-study) | 62.4 Percentage of Participants |
| Placebo (Overall Cardiovascular Study) | Percentage of Participants Experiencing an Adverse Event (AE) (Insulin With or Without Metformin Add-on Glycemic Sub-study) | 61.1 Percentage of Participants |
95% CI: [-5.8, 8.4]
95% CI: [-9.2, 5.4]
Secondary
Percentage of Participants Experiencing an Adverse Event (AE) (Metformin With Sulfonylurea Add-on Glycemic Sub-study)
An AE is defined as any unfavorable and unintended sign including an abnormal laboratory finding, symptom or disease associated with the use of a medical treatment or procedure, regardless of whether it is considered related to the medical treatment or procedure, that occurs during the course of the study.
Time frame: Up to 18 weeks
Population: The analysis population included all participants who were randomized, participated in the Metformin with Sulfonylurea Glycemic Sub-study, and who received at least one dose of blinded study medication.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Ertugliflozin 5 mg (Overall Cardiovascular Study) | Percentage of Participants Experiencing an Adverse Event (AE) (Metformin With Sulfonylurea Add-on Glycemic Sub-study) | 48.0 Percentage of Participants |
| Ertugliflozin 15 mg (Overall Cardiovascular Study) | Percentage of Participants Experiencing an Adverse Event (AE) (Metformin With Sulfonylurea Add-on Glycemic Sub-study) | 54.9 Percentage of Participants |
| Placebo (Overall Cardiovascular Study) | Percentage of Participants Experiencing an Adverse Event (AE) (Metformin With Sulfonylurea Add-on Glycemic Sub-study) | 47.0 Percentage of Participants |
95% CI: [-5.1, 20.5]
95% CI: [-12.3, 14.2]
Secondary
Percentage of Participants Experiencing an Adverse Event (AE) (Overall Cardiovascular Study)
An AE is defined as any unfavorable and unintended sign including an abnormal laboratory finding, symptom or disease associated with the use of a medical treatment or procedure, regardless of whether it is considered related to the medical treatment or procedure, that occurs during the course of the study.
Time frame: Up to approximately 6 years
Population: The analysis population included all participants who were randomized and who received at least one dose of blinded study medication.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Ertugliflozin 5 mg (Overall Cardiovascular Study) | Percentage of Participants Experiencing an Adverse Event (AE) (Overall Cardiovascular Study) | 85.8 Percentage of Participants |
| Ertugliflozin 15 mg (Overall Cardiovascular Study) | Percentage of Participants Experiencing an Adverse Event (AE) (Overall Cardiovascular Study) | 84.6 Percentage of Participants |
| Placebo (Overall Cardiovascular Study) | Percentage of Participants Experiencing an Adverse Event (AE) (Overall Cardiovascular Study) | 85.6 Percentage of Participants |
95% CI: [-2.8, 0.9]
95% CI: [-1.6, 2.1]
Secondary
Percentage of Participants Experiencing an Adverse Event (AE) (Sulfonylurea Monotherapy Add-on Glycemic Sub-Study)
An AE is defined as any unfavorable and unintended sign including an abnormal laboratory finding, symptom or disease associated with the use of a medical treatment or procedure, regardless of whether it is considered related to the medical treatment or procedure, that occurs during the course of the study.
Time frame: Up to 18 weeks
Population: The analysis population included all participants who were randomized, participated in the Sulfonylurea Monotherapy Glycemic Sub-study, and who received at least one dose of blinded study medication.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Ertugliflozin 5 mg (Overall Cardiovascular Study) | Percentage of Participants Experiencing an Adverse Event (AE) (Sulfonylurea Monotherapy Add-on Glycemic Sub-Study) | 47.3 Percentage of Participants |
| Ertugliflozin 15 mg (Overall Cardiovascular Study) | Percentage of Participants Experiencing an Adverse Event (AE) (Sulfonylurea Monotherapy Add-on Glycemic Sub-Study) | 25.9 Percentage of Participants |
| Placebo (Overall Cardiovascular Study) | Percentage of Participants Experiencing an Adverse Event (AE) (Sulfonylurea Monotherapy Add-on Glycemic Sub-Study) | 45.8 Percentage of Participants |
95% CI: [-17.7, 20.4]
95% CI: [-37.5, -1.2]
Secondary
Percentage of Participants With Albuminuria Progression or Regression at Month 24 (Overall Cardiovascular Study)
Albuminuria progression and regression were assessed relative to the baseline albuminuria category. Progression was defined as either a change from having normal albuminuria at baseline to micro-albuminuria at the respective visit, or micro-albuminuria at baseline to macro-albuminuria at the respective visit, or normal albuminuria at baseline to macro-albuminuria at the respective visit. Regression was defined as either a change from having micro-albuminuria at baseline to normal albuminuria at the respective visit, or macro-albuminuria at baseline to micro-albuminuria at the respective visit, or macro-albuminuria at baseline to normal albuminuria at the respective visit. Normal albuminuria: urine albumin to urinary creatinine ratio (UACR) \<30 (mg/g); Micro-albuminuria: UACR ≥30 and ≤300 (mg/g); Macro-albuminuria: UACR\>300 (mg/g).
Time frame: Month 24
Population: The analysis population included all participants who were randomized, received at least one dose of blinded study medication, had a baseline measurement, and at least one measurement for the analysis endpoint for the specified timepoint at Month 24.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Ertugliflozin 5 mg (Overall Cardiovascular Study) | Percentage of Participants With Albuminuria Progression or Regression at Month 24 (Overall Cardiovascular Study) | Percentage of Participants with albuminuria progression | 12.1 Percentage of Participants |
| Ertugliflozin 5 mg (Overall Cardiovascular Study) | Percentage of Participants With Albuminuria Progression or Regression at Month 24 (Overall Cardiovascular Study) | Percentage of Participants with albuminuria regression | 14.3 Percentage of Participants |
| Ertugliflozin 15 mg (Overall Cardiovascular Study) | Percentage of Participants With Albuminuria Progression or Regression at Month 24 (Overall Cardiovascular Study) | Percentage of Participants with albuminuria progression | 11.0 Percentage of Participants |
| Ertugliflozin 15 mg (Overall Cardiovascular Study) | Percentage of Participants With Albuminuria Progression or Regression at Month 24 (Overall Cardiovascular Study) | Percentage of Participants with albuminuria regression | 13.8 Percentage of Participants |
| Placebo (Overall Cardiovascular Study) | Percentage of Participants With Albuminuria Progression or Regression at Month 24 (Overall Cardiovascular Study) | Percentage of Participants with albuminuria progression | 16.9 Percentage of Participants |
| Placebo (Overall Cardiovascular Study) | Percentage of Participants With Albuminuria Progression or Regression at Month 24 (Overall Cardiovascular Study) | Percentage of Participants with albuminuria regression | 9.9 Percentage of Participants |
Secondary
Percentage of Participants With Albuminuria Progression or Regression at Month 36 (Overall Cardiovascular Study)
Albuminuria progression and regression were assessed relative to the baseline albuminuria category. Progression was defined as either a change from having normal albuminuria at baseline to micro-albuminuria at the respective visit, or micro-albuminuria at baseline to macro-albuminuria at the respective visit, or normal albuminuria at baseline to macro-albuminuria at the respective visit. Regression was defined as either a change from having micro-albuminuria at baseline to normal albuminuria at the respective visit, or macro-albuminuria at baseline to micro-albuminuria at the respective visit, or macro-albuminuria at baseline to normal albuminuria at the respective visit. Normal albuminuria: urine albumin to urinary creatinine ratio (UACR) \<30 (mg/g); Micro-albuminuria: UACR ≥30 and ≤300 (mg/g); Macro-albuminuria: UACR\>300 (mg/g).
Time frame: Month 36
Population: The analysis population included all participants who were randomized, received at least one dose of blinded study medication, had a baseline measurement, and at least one measurement for the analysis endpoint for the specified timepoint at Month 36.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Ertugliflozin 5 mg (Overall Cardiovascular Study) | Percentage of Participants With Albuminuria Progression or Regression at Month 36 (Overall Cardiovascular Study) | Participants with albuminuria progression | 14.6 Percentage of Participants |
| Ertugliflozin 5 mg (Overall Cardiovascular Study) | Percentage of Participants With Albuminuria Progression or Regression at Month 36 (Overall Cardiovascular Study) | Participants with albuminuria regression | 13.8 Percentage of Participants |
| Ertugliflozin 15 mg (Overall Cardiovascular Study) | Percentage of Participants With Albuminuria Progression or Regression at Month 36 (Overall Cardiovascular Study) | Participants with albuminuria progression | 12.5 Percentage of Participants |
| Ertugliflozin 15 mg (Overall Cardiovascular Study) | Percentage of Participants With Albuminuria Progression or Regression at Month 36 (Overall Cardiovascular Study) | Participants with albuminuria regression | 14.3 Percentage of Participants |
| Placebo (Overall Cardiovascular Study) | Percentage of Participants With Albuminuria Progression or Regression at Month 36 (Overall Cardiovascular Study) | Participants with albuminuria progression | 18.1 Percentage of Participants |
| Placebo (Overall Cardiovascular Study) | Percentage of Participants With Albuminuria Progression or Regression at Month 36 (Overall Cardiovascular Study) | Participants with albuminuria regression | 11.0 Percentage of Participants |
Secondary
Percentage of Participants With Albuminuria Progression or Regression at Month 48 (Overall Cardiovascular Study)
Albuminuria progression and regression were assessed relative to the baseline albuminuria category. Progression was defined as either a change from having normal albuminuria at baseline to micro-albuminuria at the respective visit, or micro-albuminuria at baseline to macro-albuminuria at the respective visit, or normal albuminuria at baseline to macro-albuminuria at the respective visit. Regression was defined as either a change from having micro-albuminuria at baseline to normal albuminuria at the respective visit, or macro-albuminuria at baseline to micro-albuminuria at the respective visit, or macro-albuminuria at baseline and normal albuminuria at the respective visit. Normal albuminuria: urine albumin to urinary creatinine ratio (UACR) \<30 (mg/g); Micro-albuminuria: UACR ≥30 and ≤300 (mg/g); Macro-albuminuria: UACR\>300 (mg/g).
Time frame: Month 48
Population: The analysis population included all participants who were randomized, received at least one dose of blinded study medication, had a baseline measurement, and at least one measurement for the analysis endpoint for the specified timepoint at Month 48.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Ertugliflozin 5 mg (Overall Cardiovascular Study) | Percentage of Participants With Albuminuria Progression or Regression at Month 48 (Overall Cardiovascular Study) | Percentage of Participants with albuminuria progression | 19.5 Percentage of Participants |
| Ertugliflozin 5 mg (Overall Cardiovascular Study) | Percentage of Participants With Albuminuria Progression or Regression at Month 48 (Overall Cardiovascular Study) | Percentage of Participants with albuminuria regression | 11.6 Percentage of Participants |
| Ertugliflozin 15 mg (Overall Cardiovascular Study) | Percentage of Participants With Albuminuria Progression or Regression at Month 48 (Overall Cardiovascular Study) | Percentage of Participants with albuminuria progression | 14.9 Percentage of Participants |
| Ertugliflozin 15 mg (Overall Cardiovascular Study) | Percentage of Participants With Albuminuria Progression or Regression at Month 48 (Overall Cardiovascular Study) | Percentage of Participants with albuminuria regression | 12.2 Percentage of Participants |
| Placebo (Overall Cardiovascular Study) | Percentage of Participants With Albuminuria Progression or Regression at Month 48 (Overall Cardiovascular Study) | Percentage of Participants with albuminuria progression | 21.5 Percentage of Participants |
| Placebo (Overall Cardiovascular Study) | Percentage of Participants With Albuminuria Progression or Regression at Month 48 (Overall Cardiovascular Study) | Percentage of Participants with albuminuria regression | 9.9 Percentage of Participants |
Secondary
Percentage of Participants With Albuminuria Progression or Regression at Month 60 (Overall Cardiovascular Study)
Albuminuria progression and regression were assessed relative to the baseline albuminuria category. Progression was defined as either a change from having normal albuminuria at baseline to micro albuminuria at the respective visit, or micro-albuminuria at baseline to macro-albuminuria at the respective visit, or normal albuminuria at baseline to macro-albuminuria at the respective visit. Regression was defined as either a change from having micro-albuminuria at baseline to normal albuminuria at the respective visit, or macro-albuminuria at baseline to micro-albuminuria at the respective visit, or macro-albuminuria at baseline to normal albuminuria at the respective visit. Normal albuminuria: urine albumin to urinary creatinine ratio (UACR) \<30 (mg/g); Micro-albuminuria: UACR ≥30 and ≤300 (mg/g); Macro-albuminuria: UACR\>300 (mg/g).
Time frame: Month 60
Population: The analysis population included all participants who were randomized, received at least one dose of blinded study medication, had a baseline measurement, and at least one measurement for the analysis endpoint for the specified timepoint at Month 60.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Ertugliflozin 5 mg (Overall Cardiovascular Study) | Percentage of Participants With Albuminuria Progression or Regression at Month 60 (Overall Cardiovascular Study) | Percentage of Participants with albuminuria progression | 18.6 Percentage of Participants |
| Ertugliflozin 5 mg (Overall Cardiovascular Study) | Percentage of Participants With Albuminuria Progression or Regression at Month 60 (Overall Cardiovascular Study) | Percentage of Participants with albuminuria regression | 11.3 Percentage of Participants |
| Ertugliflozin 15 mg (Overall Cardiovascular Study) | Percentage of Participants With Albuminuria Progression or Regression at Month 60 (Overall Cardiovascular Study) | Percentage of Participants with albuminuria progression | 14.7 Percentage of Participants |
| Ertugliflozin 15 mg (Overall Cardiovascular Study) | Percentage of Participants With Albuminuria Progression or Regression at Month 60 (Overall Cardiovascular Study) | Percentage of Participants with albuminuria regression | 14.8 Percentage of Participants |
| Placebo (Overall Cardiovascular Study) | Percentage of Participants With Albuminuria Progression or Regression at Month 60 (Overall Cardiovascular Study) | Percentage of Participants with albuminuria progression | 22.1 Percentage of Participants |
| Placebo (Overall Cardiovascular Study) | Percentage of Participants With Albuminuria Progression or Regression at Month 60 (Overall Cardiovascular Study) | Percentage of Participants with albuminuria regression | 10.5 Percentage of Participants |
Secondary
Percentage of Participants With Albuminuria Progression or Regression at Week 18 (Overall Cardiovascular Study)
Albuminuria progression and regression were assessed relative to the baseline albuminuria category. Progression was defined as either a change from having normal-albuminuria at baseline to micro-albuminuria at the respective visit, or micro-albuminuria at baseline to macro-albuminuria at the respective visit, or normal albuminuria at baseline to macro-albuminuria at the respective visit. Regression was defined as either a change from having micro-albuminuria at baseline to normal albuminuria at the respective visit, or macro-albuminuria at baseline to micro-albuminuria at the respective visit, or macro-albuminuria at baseline to normal albuminuria at the respective visit. Normal albuminuria: urine albumin to urinary creatinine ratio (UACR) \<30 (mg/g); Micro-albuminuria: UACR ≥30 and ≤300 (mg/g); Macro-albuminuria: UACR\>300 (mg/g).
Time frame: Week 18
Population: The analysis population included all participants who were randomized, received at least one dose of blinded study medication, had a baseline measurement, and at least one measurement for the analysis endpoint for the specified timepoint at Week 18.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Ertugliflozin 5 mg (Overall Cardiovascular Study) | Percentage of Participants With Albuminuria Progression or Regression at Week 18 (Overall Cardiovascular Study) | Percentage of Participants with albuminuria progression | 7.6 Percentage of Participants |
| Ertugliflozin 5 mg (Overall Cardiovascular Study) | Percentage of Participants With Albuminuria Progression or Regression at Week 18 (Overall Cardiovascular Study) | Percentage of Participants with albuminuria regression | 14.9 Percentage of Participants |
| Ertugliflozin 15 mg (Overall Cardiovascular Study) | Percentage of Participants With Albuminuria Progression or Regression at Week 18 (Overall Cardiovascular Study) | Percentage of Participants with albuminuria progression | 7.7 Percentage of Participants |
| Ertugliflozin 15 mg (Overall Cardiovascular Study) | Percentage of Participants With Albuminuria Progression or Regression at Week 18 (Overall Cardiovascular Study) | Percentage of Participants with albuminuria regression | 14.7 Percentage of Participants |
| Placebo (Overall Cardiovascular Study) | Percentage of Participants With Albuminuria Progression or Regression at Week 18 (Overall Cardiovascular Study) | Percentage of Participants with albuminuria progression | 10.8 Percentage of Participants |
| Placebo (Overall Cardiovascular Study) | Percentage of Participants With Albuminuria Progression or Regression at Week 18 (Overall Cardiovascular Study) | Percentage of Participants with albuminuria regression | 10.7 Percentage of Participants |
Secondary
Percentage of Participants With Albuminuria Progression or Regression at Week 52 (Overall Cardiovascular Study)
Albuminuria progression and regression were assessed relative to the baseline albuminuria category. Progression was defined as either a change from having normal albuminuria at baseline to micro-albuminuria at the respective visit, or micro-albuminuria at baseline to macro-albuminuria at the respective visit, or normal albuminuria at baseline to macro-albuminuria at the respective visit. Regression was defined as either a change from having micro-albuminuria at baseline to normal albuminuria at the respective visit, or macro-albuminuria at baseline to micro-albuminuria at the respective visit, or macro-albuminuria at baseline to normal albuminuria at the respective visit. Normal albuminuria: urine albumin to urinary creatinine ratio (UACR) \<30 (mg/g); Micro-albuminuria: UACR ≥30 and ≤300 (mg/g); Macro-albuminuria: UACR\>300 (mg/g).
Time frame: Week 52
Population: The analysis population included all participants who were randomized, received at least one dose of blinded study medication, had a baseline measurement, and at least one measurement for the analysis endpoint for the specified timepoint at Week 52.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Ertugliflozin 5 mg (Overall Cardiovascular Study) | Percentage of Participants With Albuminuria Progression or Regression at Week 52 (Overall Cardiovascular Study) | Percentage of Participants with albuminuria progression | 9.5 Percentage of Participants |
| Ertugliflozin 5 mg (Overall Cardiovascular Study) | Percentage of Participants With Albuminuria Progression or Regression at Week 52 (Overall Cardiovascular Study) | Percentage of Participants with albuminuria regression | 14.6 Percentage of Participants |
| Ertugliflozin 15 mg (Overall Cardiovascular Study) | Percentage of Participants With Albuminuria Progression or Regression at Week 52 (Overall Cardiovascular Study) | Percentage of Participants with albuminuria progression | 10.2 Percentage of Participants |
| Ertugliflozin 15 mg (Overall Cardiovascular Study) | Percentage of Participants With Albuminuria Progression or Regression at Week 52 (Overall Cardiovascular Study) | Percentage of Participants with albuminuria regression | 14.8 Percentage of Participants |
| Placebo (Overall Cardiovascular Study) | Percentage of Participants With Albuminuria Progression or Regression at Week 52 (Overall Cardiovascular Study) | Percentage of Participants with albuminuria progression | 12.9 Percentage of Participants |
| Placebo (Overall Cardiovascular Study) | Percentage of Participants With Albuminuria Progression or Regression at Week 52 (Overall Cardiovascular Study) | Percentage of Participants with albuminuria regression | 10.2 Percentage of Participants |
Secondary
Percentage of Participants With an A1C <6.5% (<48 mmol/Mol) at Month 24 (Overall Cardiovascular Study)
A1C is a blood marker used to report average blood glucose levels over prolonged periods of time and is reported as a percentage (%). A1C represents the percentage of glycated hemoglobin. Participants who met glycemic rescue criteria received glycemic rescue medication.
Time frame: Month 24
Population: The analysis population included all randomized and treated participants with an A1C measurement for the analysis endpoint for the specified timepoint(s) at Month 24.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Ertugliflozin 5 mg (Overall Cardiovascular Study) | Percentage of Participants With an A1C <6.5% (<48 mmol/Mol) at Month 24 (Overall Cardiovascular Study) | 9.2 Percentage of Participants |
| Ertugliflozin 15 mg (Overall Cardiovascular Study) | Percentage of Participants With an A1C <6.5% (<48 mmol/Mol) at Month 24 (Overall Cardiovascular Study) | 8.6 Percentage of Participants |
| Placebo (Overall Cardiovascular Study) | Percentage of Participants With an A1C <6.5% (<48 mmol/Mol) at Month 24 (Overall Cardiovascular Study) | 5.8 Percentage of Participants |
Secondary
Percentage of Participants With an A1C <6.5% (<48 mmol/Mol) at Month 36 (Overall Cardiovascular Study)
A1C is a blood marker used to report average blood glucose levels over prolonged periods of time and is reported as a percentage (%). A1C represents the percentage of glycated hemoglobin. Participants who met glycemic rescue criteria received glycemic rescue medication.
Time frame: Month 36
Population: The analysis population included all randomized and treated participants with an A1C measurement for the analysis endpoint for the specified timepoint(s) at Month 36.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Ertugliflozin 5 mg (Overall Cardiovascular Study) | Percentage of Participants With an A1C <6.5% (<48 mmol/Mol) at Month 36 (Overall Cardiovascular Study) | 7.9 Percentage of Participants |
| Ertugliflozin 15 mg (Overall Cardiovascular Study) | Percentage of Participants With an A1C <6.5% (<48 mmol/Mol) at Month 36 (Overall Cardiovascular Study) | 8.0 Percentage of Participants |
| Placebo (Overall Cardiovascular Study) | Percentage of Participants With an A1C <6.5% (<48 mmol/Mol) at Month 36 (Overall Cardiovascular Study) | 5.8 Percentage of Participants |
Secondary
Percentage of Participants With an A1C <6.5% (<48 mmol/Mol) at Month 48 (Overall Cardiovascular Study)
A1C is a blood marker used to report average blood glucose levels over prolonged periods of time and is reported as a percentage (%). A1C represents the percentage of glycated hemoglobin. Participants who met glycemic rescue criteria received glycemic rescue medication.
Time frame: Month 48
Population: The analysis population included all randomized and treated participants with an A1C measurement for the analysis endpoint for the specified timepoint(s) at Month 48.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Ertugliflozin 5 mg (Overall Cardiovascular Study) | Percentage of Participants With an A1C <6.5% (<48 mmol/Mol) at Month 48 (Overall Cardiovascular Study) | 8.1 Percentage of Participants |
| Ertugliflozin 15 mg (Overall Cardiovascular Study) | Percentage of Participants With an A1C <6.5% (<48 mmol/Mol) at Month 48 (Overall Cardiovascular Study) | 9.1 Percentage of Participants |
| Placebo (Overall Cardiovascular Study) | Percentage of Participants With an A1C <6.5% (<48 mmol/Mol) at Month 48 (Overall Cardiovascular Study) | 7.5 Percentage of Participants |
Secondary
Percentage of Participants With an A1C <6.5% (<48 mmol/Mol) at Month 60 (Overall Cardiovascular Study)
A1C is a blood marker used to report average blood glucose levels over prolonged periods of time and is reported as a percentage (%). A1C represents the percentage of glycated hemoglobin. Participants who met glycemic rescue criteria received glycemic rescue medication.
Time frame: Month 60
Population: The analysis population included all randomized and treated participants with an A1C measurement for the analysis endpoint for the specified timepoint(s) at Month 60.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Ertugliflozin 5 mg (Overall Cardiovascular Study) | Percentage of Participants With an A1C <6.5% (<48 mmol/Mol) at Month 60 (Overall Cardiovascular Study) | 5.3 Percentage of Participants |
| Ertugliflozin 15 mg (Overall Cardiovascular Study) | Percentage of Participants With an A1C <6.5% (<48 mmol/Mol) at Month 60 (Overall Cardiovascular Study) | 9.5 Percentage of Participants |
| Placebo (Overall Cardiovascular Study) | Percentage of Participants With an A1C <6.5% (<48 mmol/Mol) at Month 60 (Overall Cardiovascular Study) | 6.5 Percentage of Participants |
Secondary
Percentage of Participants With an A1C <6.5% (<48 mmol/Mol) at Week 18 (Overall Cardiovascular Study)
A1C is a blood marker used to report average blood glucose levels over prolonged periods of time and is reported as a percentage (%). A1C represents the percentage of glycated hemoglobin. Participants who met glycemic rescue criteria received glycemic rescue medication.
Time frame: Week 18
Population: The analysis population included all randomized and treated participants with an A1C measurement for the analysis endpoint for the specified timepoint(s) at Week 18.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Ertugliflozin 5 mg (Overall Cardiovascular Study) | Percentage of Participants With an A1C <6.5% (<48 mmol/Mol) at Week 18 (Overall Cardiovascular Study) | 9.0 Percentage of Participants |
| Ertugliflozin 15 mg (Overall Cardiovascular Study) | Percentage of Participants With an A1C <6.5% (<48 mmol/Mol) at Week 18 (Overall Cardiovascular Study) | 8.8 Percentage of Participants |
| Placebo (Overall Cardiovascular Study) | Percentage of Participants With an A1C <6.5% (<48 mmol/Mol) at Week 18 (Overall Cardiovascular Study) | 4.7 Percentage of Participants |
Secondary
Percentage of Participants With an A1C <6.5% (<48 mmol/Mol) at Week 52 (Overall Cardiovascular Study)
A1C is a blood marker used to report average blood glucose levels over prolonged periods of time and is reported as a percentage (%). A1C represents the percentage of glycated hemoglobin. Participants who met glycemic rescue criteria received glycemic rescue medication.
Time frame: Week 52
Population: The analysis population included all randomized and treated participants with an A1C measurement for the analysis endpoint for the specified timepoint(s) at Week 52.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Ertugliflozin 5 mg (Overall Cardiovascular Study) | Percentage of Participants With an A1C <6.5% (<48 mmol/Mol) at Week 52 (Overall Cardiovascular Study) | 9.4 Percentage of Participants |
| Ertugliflozin 15 mg (Overall Cardiovascular Study) | Percentage of Participants With an A1C <6.5% (<48 mmol/Mol) at Week 52 (Overall Cardiovascular Study) | 10.9 Percentage of Participants |
| Placebo (Overall Cardiovascular Study) | Percentage of Participants With an A1C <6.5% (<48 mmol/Mol) at Week 52 (Overall Cardiovascular Study) | 6.1 Percentage of Participants |
Secondary
Percentage of Participants With an A1C <7% (<53 mmol/Mol) at Month 24 (Overall Cardiovascular Study)
A1C is a blood marker used to report average blood glucose levels over prolonged periods of time and is reported as a percentage (%). A1C represents the percentage of glycated hemoglobin. Participants who met glycemic rescue criteria received glycemic rescue medication.
Time frame: Month 24
Population: The analysis population included all randomized and treated participants with an A1C measurement for the analysis endpoint for the specified timepoint(s) at Month 24.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Ertugliflozin 5 mg (Overall Cardiovascular Study) | Percentage of Participants With an A1C <7% (<53 mmol/Mol) at Month 24 (Overall Cardiovascular Study) | 23.9 Percentage of Participants |
| Ertugliflozin 15 mg (Overall Cardiovascular Study) | Percentage of Participants With an A1C <7% (<53 mmol/Mol) at Month 24 (Overall Cardiovascular Study) | 23.8 Percentage of Participants |
| Placebo (Overall Cardiovascular Study) | Percentage of Participants With an A1C <7% (<53 mmol/Mol) at Month 24 (Overall Cardiovascular Study) | 16.6 Percentage of Participants |
Secondary
Percentage of Participants With an A1C <7% (<53 mmol/Mol) at Month 36 (Overall Cardiovascular Study)
A1C is a blood marker used to report average blood glucose levels over prolonged periods of time and is reported as a percentage (%). A1C represents the percentage of glycated hemoglobin. Participants who met glycemic rescue criteria received glycemic rescue medication.
Time frame: Month 36
Population: The analysis population included all randomized and treated participants with an A1C measurement for the analysis endpoint for the specified timepoint(s) at Month 36.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Ertugliflozin 5 mg (Overall Cardiovascular Study) | Percentage of Participants With an A1C <7% (<53 mmol/Mol) at Month 36 (Overall Cardiovascular Study) | 23.1 Percentage of Participants |
| Ertugliflozin 15 mg (Overall Cardiovascular Study) | Percentage of Participants With an A1C <7% (<53 mmol/Mol) at Month 36 (Overall Cardiovascular Study) | 22.7 Percentage of Participants |
| Placebo (Overall Cardiovascular Study) | Percentage of Participants With an A1C <7% (<53 mmol/Mol) at Month 36 (Overall Cardiovascular Study) | 16.9 Percentage of Participants |
Secondary
Percentage of Participants With an A1C <7% (<53 mmol/Mol) at Month 48 (Overall Cardiovascular Study)
A1C is a blood marker used to report average blood glucose levels over prolonged periods of time and is reported as a percentage (%). A1C represents the percentage of glycated hemoglobin. Participants who met glycemic rescue criteria received glycemic rescue medication.
Time frame: Month 48
Population: The analysis population included all randomized and treated participants with an A1C measurement for the analysis endpoint for the specified timepoint(s) at Month 48.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Ertugliflozin 5 mg (Overall Cardiovascular Study) | Percentage of Participants With an A1C <7% (<53 mmol/Mol) at Month 48 (Overall Cardiovascular Study) | 24.9 Percentage of Participants |
| Ertugliflozin 15 mg (Overall Cardiovascular Study) | Percentage of Participants With an A1C <7% (<53 mmol/Mol) at Month 48 (Overall Cardiovascular Study) | 22.7 Percentage of Participants |
| Placebo (Overall Cardiovascular Study) | Percentage of Participants With an A1C <7% (<53 mmol/Mol) at Month 48 (Overall Cardiovascular Study) | 18.2 Percentage of Participants |
Secondary
Percentage of Participants With an A1C <7% (<53 mmol/Mol) at Month 60 (Overall Cardiovascular Study)
A1C is a blood marker used to report average blood glucose levels over prolonged periods of time and is reported as a percentage (%). A1C represents the percentage of glycated hemoglobin. Participants who met glycemic rescue criteria received glycemic rescue medication.
Time frame: Month 60
Population: The analysis population included all randomized and treated participants with an A1C measurement for the analysis endpoint for the specified timepoint(s) at Month 60.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Ertugliflozin 5 mg (Overall Cardiovascular Study) | Percentage of Participants With an A1C <7% (<53 mmol/Mol) at Month 60 (Overall Cardiovascular Study) | 18.6 Percentage of Participants |
| Ertugliflozin 15 mg (Overall Cardiovascular Study) | Percentage of Participants With an A1C <7% (<53 mmol/Mol) at Month 60 (Overall Cardiovascular Study) | 20.0 Percentage of Participants |
| Placebo (Overall Cardiovascular Study) | Percentage of Participants With an A1C <7% (<53 mmol/Mol) at Month 60 (Overall Cardiovascular Study) | 16.5 Percentage of Participants |
Secondary
Percentage of Participants With an A1C <7% (<53 mmol/Mol) at Week 18 (Excluding Rescue Approach) (Insulin With or Without Metformin Add-on Glycemic Sub-study)
A1C is a blood marker used to report average blood glucose levels over prolonged periods of time and is reported as a percentage (%). A1C represents the percentage of glycated hemoglobin. Participants who met glycemic rescue criteria received glycemic rescue medication. Excluding Rescue excluded all data following the initiation of rescue in order to avoid the confounding influence of the rescue therapy.
Time frame: Week 18
Population: The analysis population included all participants who were randomized, participated in the Insulin +/- Metformin Glycemic Sub-study, received at least one dose of study medication and had at least one measurement of the analysis endpoint for the specified timepoint(s) at any time from baseline to Week 18.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Ertugliflozin 5 mg (Overall Cardiovascular Study) | Percentage of Participants With an A1C <7% (<53 mmol/Mol) at Week 18 (Excluding Rescue Approach) (Insulin With or Without Metformin Add-on Glycemic Sub-study) | 20.7 Percentage of Participants |
| Ertugliflozin 15 mg (Overall Cardiovascular Study) | Percentage of Participants With an A1C <7% (<53 mmol/Mol) at Week 18 (Excluding Rescue Approach) (Insulin With or Without Metformin Add-on Glycemic Sub-study) | 21.1 Percentage of Participants |
| Placebo (Overall Cardiovascular Study) | Percentage of Participants With an A1C <7% (<53 mmol/Mol) at Week 18 (Excluding Rescue Approach) (Insulin With or Without Metformin Add-on Glycemic Sub-study) | 10.7 Percentage of Participants |
Comparison: Missing data imputed using the Constrained Longitudinal Data Analysis (cLDA) model fitted with fixed effects as in the primary analysis.p-value: <0.00195% CI: [1.61, 3.83]Regression, Logistic
Comparison: Missing data imputed using the Constrained Longitudinal Data Analysis (cLDA) model fitted with fixed effects as in the primary analysis.p-value: <0.00195% CI: [1.64, 4.12]Regression, Logistic
Secondary
Percentage of Participants With an A1C <7% (<53 mmol/Mol) at Week 18 (Excluding Rescue Approach) (Metformin With Sulfonylurea Add-on Glycemic Sub-study)
A1C is a blood marker used to report average blood glucose levels over prolonged periods of time and is reported as a percentage (%). A1C represents the percentage of glycated hemoglobin. Participants who met glycemic rescue criteria received glycemic rescue medication. Excluding Rescue excluded all data following the initiation of rescue in order to avoid the confounding influence of the rescue therapy.
Time frame: Week 18
Population: The analysis population included all participants who were randomized, participated in the Metformin with Sulfonylurea Glycemic Sub-study, received at least one dose of study medication and had at least one measurement of the analysis endpoint for the specified timepoint(s) at any time from baseline to Week 18.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Ertugliflozin 5 mg (Overall Cardiovascular Study) | Percentage of Participants With an A1C <7% (<53 mmol/Mol) at Week 18 (Excluding Rescue Approach) (Metformin With Sulfonylurea Add-on Glycemic Sub-study) | 37.0 Percentage of Participants |
| Ertugliflozin 15 mg (Overall Cardiovascular Study) | Percentage of Participants With an A1C <7% (<53 mmol/Mol) at Week 18 (Excluding Rescue Approach) (Metformin With Sulfonylurea Add-on Glycemic Sub-study) | 32.7 Percentage of Participants |
| Placebo (Overall Cardiovascular Study) | Percentage of Participants With an A1C <7% (<53 mmol/Mol) at Week 18 (Excluding Rescue Approach) (Metformin With Sulfonylurea Add-on Glycemic Sub-study) | 12.8 Percentage of Participants |
Comparison: Missing data imputed using the cLDA model fitted with fixed effects as in the primary analysis.p-value: <0.00195% CI: [2, 8.42]Regression, Logistic
Comparison: Missing data imputed using the cLDA model fitted with fixed effects as in the primary analysis.p-value: <0.00195% CI: [2.86, 12.49]Regression, Logistic
Secondary
Percentage of Participants With an A1C <7% (<53 mmol/Mol) at Week 18 (Excluding Rescue Approach) (Sulfonylurea Monotherapy Add-on Glycemic Sub-Study)
A1C is a blood marker used to report average blood glucose levels over prolonged periods of time and is reported as a percentage (%). A1C represents the percentage of glycated hemoglobin. Participants who met glycemic rescue criteria received glycemic rescue medication. Excluding Rescue excluded all data following the initiation of rescue in order to avoid the confounding influence of the rescue therapy.
Time frame: Week 18
Population: The analysis population included all participants who were randomized, participated in the Sulfonylurea Monotherapy Glycemic Sub-study, received at least one dose of study medication and had at least one measurement of the analysis endpoint for the specified timepoint(s) at any time from Baseline to Week 18.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Ertugliflozin 5 mg (Overall Cardiovascular Study) | Percentage of Participants With an A1C <7% (<53 mmol/Mol) at Week 18 (Excluding Rescue Approach) (Sulfonylurea Monotherapy Add-on Glycemic Sub-Study) | 32.7 Percentage of Participants |
| Ertugliflozin 15 mg (Overall Cardiovascular Study) | Percentage of Participants With an A1C <7% (<53 mmol/Mol) at Week 18 (Excluding Rescue Approach) (Sulfonylurea Monotherapy Add-on Glycemic Sub-Study) | 27.8 Percentage of Participants |
| Placebo (Overall Cardiovascular Study) | Percentage of Participants With an A1C <7% (<53 mmol/Mol) at Week 18 (Excluding Rescue Approach) (Sulfonylurea Monotherapy Add-on Glycemic Sub-Study) | 25.0 Percentage of Participants |
Comparison: Missing data imputed using the Constrained Longitudinal Data Analysis (cLDA) model fitted with fixed effects as in the primary analysis.p-value: 0.4695% CI: [0.52, 4.17]Regression, Logistic
Comparison: Missing data imputed using the Constrained Longitudinal Data Analysis (cLDA) model fitted with fixed effects as in the primary analysis.p-value: 0.33595% CI: [0.61, 4.35]Regression, Logistic
Secondary
Percentage of Participants With an A1C <7% (<53 mmol/Mol) at Week 18 (Overall Cardiovascular Study)
A1C is a blood marker used to report average blood glucose levels over prolonged periods of time and is reported as a percentage (%). A1C represents the percentage of glycated hemoglobin. Participants who met glycemic rescue criteria received glycemic rescue medication.
Time frame: Week 18
Population: The analysis population included all randomized and treated participants with an A1C measurement for the analysis endpoint for the specified timepoint(s) at Week 18.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Ertugliflozin 5 mg (Overall Cardiovascular Study) | Percentage of Participants With an A1C <7% (<53 mmol/Mol) at Week 18 (Overall Cardiovascular Study) | 28.4 Percentage of Participants |
| Ertugliflozin 15 mg (Overall Cardiovascular Study) | Percentage of Participants With an A1C <7% (<53 mmol/Mol) at Week 18 (Overall Cardiovascular Study) | 28.2 Percentage of Participants |
| Placebo (Overall Cardiovascular Study) | Percentage of Participants With an A1C <7% (<53 mmol/Mol) at Week 18 (Overall Cardiovascular Study) | 15.5 Percentage of Participants |
Secondary
Percentage of Participants With an A1C <7% (<53 mmol/Mol) at Week 52 (Overall Cardiovascular Study)
A1C is a blood marker used to report average blood glucose levels over prolonged periods of time and is reported as a percentage (%). A1C represents the percentage of glycated hemoglobin. Participants who met glycemic rescue criteria received glycemic rescue medication.
Time frame: Week 52
Population: The analysis population included all randomized and treated participants with an A1C measurement for the analysis endpoint for the specified timepoint(s) at Week 52.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Ertugliflozin 5 mg (Overall Cardiovascular Study) | Percentage of Participants With an A1C <7% (<53 mmol/Mol) at Week 52 (Overall Cardiovascular Study) | 28.3 Percentage of Participants |
| Ertugliflozin 15 mg (Overall Cardiovascular Study) | Percentage of Participants With an A1C <7% (<53 mmol/Mol) at Week 52 (Overall Cardiovascular Study) | 29.0 Percentage of Participants |
| Placebo (Overall Cardiovascular Study) | Percentage of Participants With an A1C <7% (<53 mmol/Mol) at Week 52 (Overall Cardiovascular Study) | 17.4 Percentage of Participants |
Secondary
Percent Change From Baseline in Urinary Albumin/Creatinine Ratio at Month 24 (Overall Cardiovascular Study)
This percent change relative to baseline reflects the Month 24 albumin/creatinine ratio minus the Week 0 albumin/creatinine ratio. This difference was divided by the baseline to obtain the percent change. A negative number indicates a reduction in urinary albumin/creatinine ratio. Participants who met glycemic rescue criteria received glycemic rescue medication.
Time frame: Baseline and Month 24
Population: The analysis population included all participants who were randomized, received at least one dose of blinded study medication, and had a measurement for the analysis endpoint for the specified timepoint(s) at both Baseline and Month 24.
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| Ertugliflozin 5 mg (Overall Cardiovascular Study) | Percent Change From Baseline in Urinary Albumin/Creatinine Ratio at Month 24 (Overall Cardiovascular Study) | -0.73 Percent Change |
| Ertugliflozin 15 mg (Overall Cardiovascular Study) | Percent Change From Baseline in Urinary Albumin/Creatinine Ratio at Month 24 (Overall Cardiovascular Study) | 1.06 Percent Change |
| Placebo (Overall Cardiovascular Study) | Percent Change From Baseline in Urinary Albumin/Creatinine Ratio at Month 24 (Overall Cardiovascular Study) | 17.14 Percent Change |
Secondary
Percent Change From Baseline in Urinary Albumin/Creatinine Ratio at Month 36 (Overall Cardiovascular Study)
This percent change relative to baseline reflects the Month 36 albumin/creatinine ratio minus the Week 0 albumin/creatinine ratio. This difference was divided by the baseline to obtain the percent change. A negative number indicates a reduction in urinary albumin/creatinine ratio. Participants who met glycemic rescue criteria received glycemic rescue medication.
Time frame: Baseline and Month 36
Population: The analysis population included all participants who were randomized, received at least one dose of blinded study medication, and had a measurement for the analysis endpoint for the specified timepoint(s) at both Baseline and Month 36.
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| Ertugliflozin 5 mg (Overall Cardiovascular Study) | Percent Change From Baseline in Urinary Albumin/Creatinine Ratio at Month 36 (Overall Cardiovascular Study) | 13.33 Percent Change |
| Ertugliflozin 15 mg (Overall Cardiovascular Study) | Percent Change From Baseline in Urinary Albumin/Creatinine Ratio at Month 36 (Overall Cardiovascular Study) | 3.33 Percent Change |
| Placebo (Overall Cardiovascular Study) | Percent Change From Baseline in Urinary Albumin/Creatinine Ratio at Month 36 (Overall Cardiovascular Study) | 27.03 Percent Change |
Secondary
Percent Change From Baseline in Urinary Albumin/Creatinine Ratio at Month 48 (Overall Cardiovascular Study)
This percent change relative to baseline reflects the Month 48 albumin/creatinine ratio minus the Week 0 albumin/creatinine ratio. This difference was divided by the baseline to obtain the percent change. A negative number indicates a reduction in albumin/creatinine ratio. Participants who met glycemic rescue criteria received glycemic rescue medication.
Time frame: Baseline and Month 48
Population: The analysis population included all participants who were randomized, received at least one dose of blinded study medication, and had a measurement for the analysis endpoint for the specified timepoint(s) at both Baseline and Month 48.
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| Ertugliflozin 5 mg (Overall Cardiovascular Study) | Percent Change From Baseline in Urinary Albumin/Creatinine Ratio at Month 48 (Overall Cardiovascular Study) | 33.33 Percent Change |
| Ertugliflozin 15 mg (Overall Cardiovascular Study) | Percent Change From Baseline in Urinary Albumin/Creatinine Ratio at Month 48 (Overall Cardiovascular Study) | 21.25 Percent Change |
| Placebo (Overall Cardiovascular Study) | Percent Change From Baseline in Urinary Albumin/Creatinine Ratio at Month 48 (Overall Cardiovascular Study) | 50.00 Percent Change |
Secondary
Percent Change From Baseline in Urinary Albumin/Creatinine Ratio at Month 60 (Overall Cardiovascular Study)
This percent change relative to baseline reflects the Month 60 albumin/creatinine ratio minus the Week 0 albumin/creatinine ratio. This difference was divided by the baseline to obtain the percent change. A negative number indicates a reduction in albumin/creatinine ratio. Participants who met glycemic rescue criteria received glycemic rescue medication.
Time frame: Baseline and Month 60
Population: The analysis population included all participants who were randomized, received at least one dose of blinded study medication, and had a measurement for the analysis endpoint for the specified timepoint(s) at both Baseline and Month 60.
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| Ertugliflozin 5 mg (Overall Cardiovascular Study) | Percent Change From Baseline in Urinary Albumin/Creatinine Ratio at Month 60 (Overall Cardiovascular Study) | 30.99 Percent Change |
| Ertugliflozin 15 mg (Overall Cardiovascular Study) | Percent Change From Baseline in Urinary Albumin/Creatinine Ratio at Month 60 (Overall Cardiovascular Study) | 20.00 Percent Change |
| Placebo (Overall Cardiovascular Study) | Percent Change From Baseline in Urinary Albumin/Creatinine Ratio at Month 60 (Overall Cardiovascular Study) | 48.53 Percent Change |
Secondary
Percent Change From Baseline in Urinary Albumin/Creatinine Ratio at Week 18 (Overall Cardiovascular Study)
This percent change relative to baseline reflects the Week 18 albumin/creatinine ratio minus the Week 0 albumin/creatinine ratio. This difference was divided by the baseline to obtain the percent change. A negative number indicates a reduction in the urinary albumin/creatinine ratio. Participants who met glycemic rescue criteria received glycemic rescue medication.
Time frame: Baseline and Week 18
Population: The analysis population included all participants who were randomized, received at least one dose of blinded study medication, and had a measurement for the analysis endpoint for the specified timepoint(s) at both Baseline and Week 18.
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| Ertugliflozin 5 mg (Overall Cardiovascular Study) | Percent Change From Baseline in Urinary Albumin/Creatinine Ratio at Week 18 (Overall Cardiovascular Study) | -13.40 Percent Change |
| Ertugliflozin 15 mg (Overall Cardiovascular Study) | Percent Change From Baseline in Urinary Albumin/Creatinine Ratio at Week 18 (Overall Cardiovascular Study) | -14.71 Percent Change |
| Placebo (Overall Cardiovascular Study) | Percent Change From Baseline in Urinary Albumin/Creatinine Ratio at Week 18 (Overall Cardiovascular Study) | 0.00 Percent Change |
Secondary
Percent Change From Baseline in Urinary Albumin/Creatinine Ratio at Week 52 (Overall Cardiovascular Study)
This percent change relative to baseline reflects the Week 52 albumin/creatinine ratio minus the Week 0 albumin/creatinine ratio. This difference was divided by the baseline to obtain the percent change. A negative number indicates a reduction in the albumin/creatinine ratio. Participants who met glycemic rescue criteria received glycemic rescue medication.
Time frame: Baseline and Week 52
Population: The analysis population included all participants who were randomized, received at least one dose of blinded study medication, and had a measurement for the analysis endpoint for the specified timepoint(s) at both Baseline and Week 52.
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| Ertugliflozin 5 mg (Overall Cardiovascular Study) | Percent Change From Baseline in Urinary Albumin/Creatinine Ratio at Week 52 (Overall Cardiovascular Study) | -2.53 Percent Change |
| Ertugliflozin 15 mg (Overall Cardiovascular Study) | Percent Change From Baseline in Urinary Albumin/Creatinine Ratio at Week 52 (Overall Cardiovascular Study) | -6.82 Percent Change |
| Placebo (Overall Cardiovascular Study) | Percent Change From Baseline in Urinary Albumin/Creatinine Ratio at Week 52 (Overall Cardiovascular Study) | 5.41 Percent Change |
Secondary
Time to First Occurrence of Fatal or Non-fatal Myocardial Infarction (On-Study Approach) (Overall Cardiovascular Study)
Time to First Occurrence of Fatal or Non-fatal Myocardial Infarction. The on-study approach included confirmed events that occurred between the randomization date and the on-study censor date. Person-years was calculated as the sum of participants' time to first event or time to censoring (the earliest of participants' end of study date, death date, or last contact date).
Time frame: Up to approximately 6 years
Population: The analysis population included all randomized participants.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Ertugliflozin 5 mg (Overall Cardiovascular Study) | Time to First Occurrence of Fatal or Non-fatal Myocardial Infarction (On-Study Approach) (Overall Cardiovascular Study) | 1.55 Events per 100 Person-years |
| Ertugliflozin 15 mg (Overall Cardiovascular Study) | Time to First Occurrence of Fatal or Non-fatal Myocardial Infarction (On-Study Approach) (Overall Cardiovascular Study) | 2.00 Events per 100 Person-years |
| Placebo (Overall Cardiovascular Study) | Time to First Occurrence of Fatal or Non-fatal Myocardial Infarction (On-Study Approach) (Overall Cardiovascular Study) | 1.70 Events per 100 Person-years |
| All Ertugliflozin (Overall Cardiovascular Study) | Time to First Occurrence of Fatal or Non-fatal Myocardial Infarction (On-Study Approach) (Overall Cardiovascular Study) | 1.77 Events per 100 Person-years |
p-value: 0.67695% CI: [0.861, 1.259]Cox Proportional Hazards Model
p-value: 0.13995% CI: [0.949, 1.451]Cox Proportional Hazards Model
p-value: 0.41695% CI: [0.727, 1.141]Cox Proportional Hazards Model
Secondary
Time to First Occurrence of Fatal or Non-fatal Stroke (FNF Stroke) (On-Study Approach) (Overall Cardiovascular Study)
Time to the first occurrence of fatal and no-fatal stroke. The on-study approach included confirmed events that occurred between the randomization date and the on-study censor date. Person-years was calculated as the sum of participants' time to first event or time to censoring (the earliest of participants' end of study date, death date, or last contact date). The on-study approach included events that occurred between the randomization date and the on-study censor date.
Time frame: Up to approximately 6 years
Population: The analysis population included all randomized participants.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Ertugliflozin 5 mg (Overall Cardiovascular Study) | Time to First Occurrence of Fatal or Non-fatal Stroke (FNF Stroke) (On-Study Approach) (Overall Cardiovascular Study) | 0.92 Events per 100 Person-years |
| Ertugliflozin 15 mg (Overall Cardiovascular Study) | Time to First Occurrence of Fatal or Non-fatal Stroke (FNF Stroke) (On-Study Approach) (Overall Cardiovascular Study) | 1.04 Events per 100 Person-years |
| Placebo (Overall Cardiovascular Study) | Time to First Occurrence of Fatal or Non-fatal Stroke (FNF Stroke) (On-Study Approach) (Overall Cardiovascular Study) | 0.93 Events per 100 Person-years |
| All Ertugliflozin (Overall Cardiovascular Study) | Time to First Occurrence of Fatal or Non-fatal Stroke (FNF Stroke) (On-Study Approach) (Overall Cardiovascular Study) | 0.98 Events per 100 Person-years |
p-value: 0.66395% CI: [0.82, 1.365]Cox proportional hazards model
Comparison: Hazard ratio, confidence interval, and two-sided p-value comparing Ertugliflozin vs Placebo, based on the stratified Cox proportional hazards model that includes treatment as an explanatory factor and cohort category as a stratification factor.p-value: 0.41595% CI: [0.845, 1.505]Cox proportional hazards model
Comparison: Hazard ratio, confidence interval, and two-sided p-value comparing Ertugliflozin vs Placebo, based on the stratified Cox proportional hazards model that includes treatment as an explanatory factor and cohort category as a stratification factor.p-value: 0.95395% CI: [0.736, 1.334]Cox proportional hazards model
Secondary
Time to First Occurrence of Hospitalization for Heart Failure (HHF) (On-Study Approach) (Overall Cardiovascular Study)
Time to the first occurrence of heart failure requiring hospitalization (adjudicated). The on-study approach included confirmed events that occurred between the randomization date and the on-study censor date. Person-years was calculated as the sum of participants' time to first event or time to censoring (the earliest of participants' end of study date, death date, or last contact date). The on-study approach included events that occurred between the randomization date and the on-study censor date.
Time frame: Up to approximately 6 years
Population: The analysis population included all randomized participants.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Ertugliflozin 5 mg (Overall Cardiovascular Study) | Time to First Occurrence of Hospitalization for Heart Failure (HHF) (On-Study Approach) (Overall Cardiovascular Study) | 0.75 Events per 100 Person-years |
| Ertugliflozin 15 mg (Overall Cardiovascular Study) | Time to First Occurrence of Hospitalization for Heart Failure (HHF) (On-Study Approach) (Overall Cardiovascular Study) | 0.72 Events per 100 Person-years |
| Placebo (Overall Cardiovascular Study) | Time to First Occurrence of Hospitalization for Heart Failure (HHF) (On-Study Approach) (Overall Cardiovascular Study) | 1.05 Events per 100 Person-years |
| All Ertugliflozin (Overall Cardiovascular Study) | Time to First Occurrence of Hospitalization for Heart Failure (HHF) (On-Study Approach) (Overall Cardiovascular Study) | 0.73 Events per 100 Person-years |
p-value: 0.00695% CI: [0.539, 0.902]Cox proportional hazards model
p-value: 0.01695% CI: [0.502, 0.932]Cox Proportional Hazards Model
p-value: 0.02895% CI: [0.524, 0.964]Cox Proportional Hazards Model
Secondary
Time to First Occurrence of MACE Plus (Composite Endpoint of Cardiovascular Death, Non-fatal Myocardial Infarction, Non-fatal Stroke or Hospitalization for Unstable Angina) (On-Study Approach) (Overall Cardiovascular Study)
Time to the first occurrence of any of the following adjudicated components 4-point MACE: cardiovascular death (including fatal stroke and fatal myocardial infarction), non-fatal myocardial infarction, non-fatal stroke, and hospitalization for unstable angina pectoris. The on-study approach included confirmed events that occurred between the randomization date and the on-study censor date. Person-years was calculated as the sum of participants' time to first event or time to censoring (the earliest of participants' end of study date, death date, or last contact date). The on-study approach included events that occurred between the randomization date and the on-study censor date.
Time frame: Up to approximately 6 years
Population: The analysis population included all randomized participants.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Ertugliflozin 5 mg (Overall Cardiovascular Study) | Time to First Occurrence of MACE Plus (Composite Endpoint of Cardiovascular Death, Non-fatal Myocardial Infarction, Non-fatal Stroke or Hospitalization for Unstable Angina) (On-Study Approach) (Overall Cardiovascular Study) | 4.42 Events per 100 Person-years |
| Ertugliflozin 15 mg (Overall Cardiovascular Study) | Time to First Occurrence of MACE Plus (Composite Endpoint of Cardiovascular Death, Non-fatal Myocardial Infarction, Non-fatal Stroke or Hospitalization for Unstable Angina) (On-Study Approach) (Overall Cardiovascular Study) | 4.67 Events per 100 Person-years |
| Placebo (Overall Cardiovascular Study) | Time to First Occurrence of MACE Plus (Composite Endpoint of Cardiovascular Death, Non-fatal Myocardial Infarction, Non-fatal Stroke or Hospitalization for Unstable Angina) (On-Study Approach) (Overall Cardiovascular Study) | 4.92 Events per 100 Person-years |
| All Ertugliflozin (Overall Cardiovascular Study) | Time to First Occurrence of MACE Plus (Composite Endpoint of Cardiovascular Death, Non-fatal Myocardial Infarction, Non-fatal Stroke or Hospitalization for Unstable Angina) (On-Study Approach) (Overall Cardiovascular Study) | 4.54 Events per 100 Person-years |
p-value: 0.18395% CI: [0.823, 1.038]Cox proportional hazards model
p-value: 0.4595% CI: [0.831, 1.086]Cox Proportional Hazards Model
p-value: 0.12395% CI: [0.785, 1.029]Cox Proportional Hazards Model
Secondary
Time to First Occurrence of the Renal Composite: the Composite of Renal Death, Renal Dialysis/Transplant, or Doubling of Serum Creatinine From Baseline (On-Study Approach) (Overall Cardiovascular Study)
Renal composite endpoint was defined as a composite of renal death, renal dialysis/transplant, or doubling of serum creatinine from baseline. The on-study approach included events that occurred between the randomization date and the on-study censor date. Person-years was calculated as the sum of participants' time to first event or time to censoring (the earliest of participants' end of study date, death date, or last contact date). The on-study approach included events that occurred between the randomization date and the on-study censor date.
Time frame: Up to approximately 6 years
Population: The analysis population included all randomized participants.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Ertugliflozin 5 mg (Overall Cardiovascular Study) | Time to First Occurrence of the Renal Composite: the Composite of Renal Death, Renal Dialysis/Transplant, or Doubling of Serum Creatinine From Baseline (On-Study Approach) (Overall Cardiovascular Study) | 0.87 Events per 100 Person-years |
| Ertugliflozin 15 mg (Overall Cardiovascular Study) | Time to First Occurrence of the Renal Composite: the Composite of Renal Death, Renal Dialysis/Transplant, or Doubling of Serum Creatinine From Baseline (On-Study Approach) (Overall Cardiovascular Study) | 0.98 Events per 100 Person-years |
| Placebo (Overall Cardiovascular Study) | Time to First Occurrence of the Renal Composite: the Composite of Renal Death, Renal Dialysis/Transplant, or Doubling of Serum Creatinine From Baseline (On-Study Approach) (Overall Cardiovascular Study) | 1.15 Events per 100 Person-years |
| All Ertugliflozin (Overall Cardiovascular Study) | Time to First Occurrence of the Renal Composite: the Composite of Renal Death, Renal Dialysis/Transplant, or Doubling of Serum Creatinine From Baseline (On-Study Approach) (Overall Cardiovascular Study) | 0.93 Events per 100 Person-years |
p-value: 0.08195.8% CI: [0.63, 1.036]Cox Proportional Hazards Model
p-value: 0.25895.8% CI: [0.638, 1.137]Cox Proportional Hazard Model
p-value: 0.06595.8% CI: [0.568, 1.028]Cox Proportional Hazards Model
Secondary
Time to Initiation of Insulin for Participants Not on Insulin at Baseline (Overall Cardiovascular Study)
Participants who were not on insulin therapy at the start of study medication.
Time frame: Up to approximately 6 years
Population: The analysis population included all participants who were randomized, received at least one dose of blinded study medication, and were not on insulin therapy at the start of study medication.
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| Ertugliflozin 5 mg (Overall Cardiovascular Study) | Time to Initiation of Insulin for Participants Not on Insulin at Baseline (Overall Cardiovascular Study) | 602 Days |
| Ertugliflozin 15 mg (Overall Cardiovascular Study) | Time to Initiation of Insulin for Participants Not on Insulin at Baseline (Overall Cardiovascular Study) | 650 Days |
| Placebo (Overall Cardiovascular Study) | Time to Initiation of Insulin for Participants Not on Insulin at Baseline (Overall Cardiovascular Study) | 482 Days |
p-value: <0.001Log Rank
p-value: <0.001Log Rank
Secondary
Time to Occurrence of Cardiovascular (CV) Death or Hospitalization for Heart Failure (HHF) (On-Study Approach) (Overall Cardiovascular Study)
Time to the occurrence of any of the following adjudicated components of cardiovascular (CV) death (including fatal stroke and fatal myocardial infarction (MI)) or hospitalization for heart failure. The on-study approach included confirmed events that occurred between the randomization date and the on-study censor date. Person-years was calculated as the sum of participants' time to event or time to censoring (the earliest of participants' end of study date, death date, or last contact date).
Time frame: Up to approximately 6 years
Population: The analysis population included all randomized participants.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Ertugliflozin 5 mg (Overall Cardiovascular Study) | Time to Occurrence of Cardiovascular (CV) Death or Hospitalization for Heart Failure (HHF) (On-Study Approach) (Overall Cardiovascular Study) | 2.36 Events per 100 Person-years |
| Ertugliflozin 15 mg (Overall Cardiovascular Study) | Time to Occurrence of Cardiovascular (CV) Death or Hospitalization for Heart Failure (HHF) (On-Study Approach) (Overall Cardiovascular Study) | 2.33 Events per 100 Person-years |
| Placebo (Overall Cardiovascular Study) | Time to Occurrence of Cardiovascular (CV) Death or Hospitalization for Heart Failure (HHF) (On-Study Approach) (Overall Cardiovascular Study) | 2.66 Events per 100 Person-years |
| All Ertugliflozin (Overall Cardiovascular Study) | Time to Occurrence of Cardiovascular (CV) Death or Hospitalization for Heart Failure (HHF) (On-Study Approach) (Overall Cardiovascular Study) | 2.34 Events per 100 Person-years |
p-value: 0.10895.8% CI: [0.75, 1.034]Cox Proportional Hazards Model
p-value: 0.1595.8% CI: [0.725, 1.057]Cox Proportional Hazards Model
p-value: 0.18895.8% CI: [0.735, 1.068]Cox Proportional Hazards Model
Secondary
Time to Occurrence of Cardiovascular Death (On-study Approach) (Overall Cardiovascular Study)
Time to the occurrence of cardiovascular (CV) death (including fatal stroke and fatal myocardial infarction (MI)). The on-study approach included confirmed events that occurred between the randomization date and the on-study censor date. Person-years was calculated as the sum of participants' time to CV death or time to censoring (the earliest of participants' end of study date or date last known to be alive).
Time frame: Up to approximately 6 years
Population: The analysis population included all randomized participants.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Ertugliflozin 5 mg (Overall Cardiovascular Study) | Time to Occurrence of Cardiovascular Death (On-study Approach) (Overall Cardiovascular Study) | 1.77 Events per 100 Person-years |
| Ertugliflozin 15 mg (Overall Cardiovascular Study) | Time to Occurrence of Cardiovascular Death (On-study Approach) (Overall Cardiovascular Study) | 1.74 Events per 100 Person-years |
| Placebo (Overall Cardiovascular Study) | Time to Occurrence of Cardiovascular Death (On-study Approach) (Overall Cardiovascular Study) | 1.90 Events per 100 Person-years |
| All Ertugliflozin (Overall Cardiovascular Study) | Time to Occurrence of Cardiovascular Death (On-study Approach) (Overall Cardiovascular Study) | 1.76 Events per 100 Person-years |
p-value: 0.38595.8% CI: [0.767, 1.113]Cox Proportional Hazards Model
p-value: 0.41795.8% CI: [0.739, 1.139]Cox Proportional Hazards Model
p-value: 0.49495.8% CI: [0.75, 1.154]Cox Proportional Hazards Model
Secondary
Time to Occurrence of Death From Any Cause (On-Study Approach) (Overall Cardiovascular Study)
Time to the occurrence of death from any cause. The on-study approach included confirmed events that occurred between the randomization date and the on-study censor date. Person-years was calculated as the sum of participants' time to event or time to censoring (the earliest of participants' end of study date, death date, last contact date, or date last known to be alive. The on-study approach included events that occurred between the randomization date and the on-study censor date.
Time frame: Up to approximately 6 years
Population: The analysis population included all randomized participants.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Ertugliflozin 5 mg (Overall Cardiovascular Study) | Time to Occurrence of Death From Any Cause (On-Study Approach) (Overall Cardiovascular Study) | 2.42 Events per 100 Person-years |
| Ertugliflozin 15 mg (Overall Cardiovascular Study) | Time to Occurrence of Death From Any Cause (On-Study Approach) (Overall Cardiovascular Study) | 2.46 Events per 100 Person-years |
| Placebo (Overall Cardiovascular Study) | Time to Occurrence of Death From Any Cause (On-Study Approach) (Overall Cardiovascular Study) | 2.62 Events per 100 Person-years |
| All Ertugliflozin (Overall Cardiovascular Study) | Time to Occurrence of Death From Any Cause (On-Study Approach) (Overall Cardiovascular Study) | 2.44 Events per 100 Person-years |
p-value: 0.3495% CI: [0.797, 1.081]Cox proportional hazards model
p-value: 0.46395% CI: [0.784, 1.117]Cox Proportional Hazards Model
p-value: 0.36395% CI: [0.771, 1.1]Cox Proportional Hazards Model
Secondary
Time to the First Occurrence of a Participant Receiving Glycemic Rescue Therapy Through Week 18 (Overall Cardiovascular Study)
Participants who met glycemic rescue criteria received open-label sitagliptin glycemic rescue medication.
Time frame: Up to 18 weeks
Population: The analysis population included all participants who were randomized, received at least one dose of blinded study medication, and received glycemic rescue by Week 18.
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| Ertugliflozin 5 mg (Overall Cardiovascular Study) | Time to the First Occurrence of a Participant Receiving Glycemic Rescue Therapy Through Week 18 (Overall Cardiovascular Study) | 59.0 Days |
| Ertugliflozin 15 mg (Overall Cardiovascular Study) | Time to the First Occurrence of a Participant Receiving Glycemic Rescue Therapy Through Week 18 (Overall Cardiovascular Study) | 51.0 Days |
| Placebo (Overall Cardiovascular Study) | Time to the First Occurrence of a Participant Receiving Glycemic Rescue Therapy Through Week 18 (Overall Cardiovascular Study) | 74.0 Days |
p-value: <0.001Log Rank
p-value: <0.001Log Rank