Type 2 Diabetes Mellitus
Conditions
Brief summary
This is a study to evaluate the efficacy and safety of ertugliflozin (MK-8835/PF-04971729) in combination with sitagliptin in the treatment of participants with Type 2 diabetes mellitus (T2DM) with inadequate glycemic control on diet and exercise. The primary hypothesis of the study is that ertugliflozin plus sitagliptin is more effective in lowering of hemoglobin A1C (HbA1C) than placebo.
Detailed description
Each participant will be in the study for approximately 39 weeks including: a 1-week screening period, an 8-week (or greater) antihyperglycemic agent (AHA) wash-off period, a 2-week single-blind placebo run-in period, a 26-week double-blind treatment period, and a post-treatment telephone contact 14 days after the last dose of study drug.
Interventions
DRUGErtugliflozin
Ertugliflozin, 5 mg or 15 mg, administered orally, once daily for 26 weeks.
DRUGSitagliptin
Sitagliptin, 100 mg, administered orally, once daily for 26 weeks.
Matching placebo to ertugliflozin administered orally, once daily for 26 weeks.
Matching placebo to sitagliptin administered orally, once daily for 26 weeks.
DRUGGlimepiride
Open-label glimepiride rescue therapy will be initiated at 1 or 2 mg/day and may be titrated to the maximum labeled dose or maximum tolerated dose (if lower than labeled dose), as considered appropriate by the investigator, based on blood glucose measurements and in accordance with the local, approved label.
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
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Type 2 diabetes mellitus as per American Diabetes Association guidelines * Not on antihyperglycemic agent (AHA) \>=8 weeks with a Visit 1/Screening HbA1C \>=8.0% and \<=10.5% (\>=64 mmol/mol and \<=91 mmol/mol) OR on single allowable AHA (allowable AHAs prior to screening are: metformin, α-glucosidase inhibitors, sulfonylureas and glinides) with a Visit 1/Screening HbA1C \>=7.5% and \<=10.0% (\>=58 mmol/mol and \<=86 mmol/mol) OR on low-dose dual combination therapy (≤50% of maximum labeled dose of an AHA) with allowable AHAs with a Visit 1/Screening HbA1C \>=7.5% and \<=10.0% (\>=58 mmol/mol and \<=86 mmol/mol) * Body mass index (BMI) \>=18.0 kg/m\^2 * Male or female not of reproductive potential * Female of reproductive potential who agrees to (or have their partner agree to) remain abstinent from heterosexual activity or to use 2 acceptable combinations of contraception.
Exclusion criteria
* History of type 1 diabetes mellitus or diabetic ketoacidosis * History of other specific types of diabetes (e.g., genetic syndromes, secondary pancreatic diabetes, diabetes due to endocrinopathies, drug- or chemical-induced, and post-organ transplant * A known hypersensitivity or intolerance to any sodium glucose co-transporter (SGLT2) inhibitor or sitagliptin * Has been treated with any of the following agents within 12 weeks of study start or during the pre-randomization period: insulin of any type (except for short-term use \[i.e., \<=7 days\] during concomitant illness or other stress), other injectable anti-hyperglycemic agents (e.g., pramlintide, exenatide, liraglutide), pioglitazone or rosiglitazone, other sodium glucose co-transporter 2 (SGLT2) inhibitors, dipeptidyl-peptidase 4 inhibitors (DPP-4 inhibitors), bromocriptine (Cycloset™), colesevelam (Welchol™), any other AHA with the exception of the protocol-approved agents * Is on a weight-loss program or weight-loss medication or other medication associated with weight changes and is not weight stable prior to study start * Has undergone bariatric surgery within the past 12 months or \>12 months and is not weight stable prior to study start * A history of myocardial infarction, unstable angina, arterial revascularization, stroke, transient ischemic attack, or New York Heart Association (NYHA) functional Class III-IV heart failure within 3 months of study start * Active, obstructive uropathy or indwelling urinary catheter * History of malignancy \<=5 years prior to study start, except for adequately treated basal cell or squamous cell skin cancer or in situ cervical cancer * A known history of human immunodeficiency virus (HIV) * A blood dyscrasia or any disorder causing hemolysis or unstable red blood cells, or a clinically important hematological disorder (e.g. aplastic anemia, myeloproliferative or myelodysplastic syndromes, thrombocytopenia) * A medical history of active liver disease (other than non-alcoholic hepatic steatosis), including chronic active hepatitis B or C, primary biliary cirrhosis, or symptomatic gallbladder disease * Any clinically significant malabsorption condition * Current treatment for hyperthyroidism * On thyroid replacement therapy and not on a stable dose for at least 6 weeks prior study start * On a previous clinical study with ertugliflozin * Participated in other studies involving investigational drug(s) 30 days prior to study start * Surgical procedure within 6 weeks prior to study start or major surgery planned during the trial * Positive urine pregnancy test * Pregnant or breast-feeding, or planning to conceive during the trial, including 14 days following the last dose of study medication * Planning to undergo hormonal therapy in preparation for egg donation during the trial, including 14 days following the last dose of study medication * Routinely consumes \>2 alcoholic drinks per day or \>14 alcoholic drinks per week or engages in binge drinking * Donated blood or blood products within 6 weeks of study start.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Change From Baseline in Hemoglobin A1C (HbA1C) at Week 26 - Full Analysis Set (FAS Population Excluding Rescue Approach | Baseline and Week 26 | HbA1C is blood marker used to report average blood glucose levels over prolonged periods of time and is reported as a percentage (%). HbA1C represents the percentage of glycated hemoglobin. A negative number indicates a reduction in HbA1C level. Excluding rescue approach excludes all data following the initiation of rescue, in order to avoid the confounding influence of the rescue therapy with open-label glimepiride. |
| Percentage of Participants Who Experienced an Adverse Event (AE) - All Participants as Treated Excluding Rescue Approach | Up to Week 28 | An adverse event (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. Excluding rescue approach excludes all data following the initiation of rescue, in order to avoid the confounding influence of the rescue therapy with open-label glimepiride. |
| Percentage of Participants Who Discontinued Study Medication Due to an AE - All Participants as Treated Excluding Rescue Approach | Up to Week 26 | 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. Excluding rescue approach excludes all data following the initiation of rescue, in order to avoid the confounding influence of the rescue therapy with open-label glimepiride. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Change From Baseline in Body Weight at Week 26 - Full Analysis Set Excluding Rescue Approach | Baseline and Week 26 | Body weight was measured using a standardized, digital scale at each of the pre-defined nominal time points. Weight was taken in duplicate throughout the trial at approximately the same time of day, after voiding (i.e., forced void) and while wearing only a gown and underwear. Excluding rescue approach excludes all data following the initiation of rescue, in order to avoid the confounding influence of the rescue therapy with open-label glimepiride. |
| Change From Baseline in Fasting Plasma Glucose (FPG) at Week 26 - Full Analysis Set Excluding Rescue Approach | Baseline and Week 26 | Blood glucose was measured after a ≥10 hour fast. Blood was drawn at predose on Day 1 and after 26 weeks of treatment to determine change in plasma glucose levels (i.e., FPG at Week 26 minus FPG at baseline). Excluding rescue approach excludes all data following the initiation of rescue, in order to avoid the confounding influence of the rescue therapy with open-label glimepiride. |
| Change From Baseline in Sitting Diastolic Blood Pressure at Week 26 - Full Analysis Set Excluding Rescue Approach | Baseline and Week 26 | Blood pressure measurements were taken after at least 5 minutes of rest. Three measurements were taken approximately 2 minutes apart with the triplicate set recorded. Excluding rescue approach excludes all data following the initiation of rescue, in order to avoid the confounding influence of the rescue therapy with open-label glimepiride. |
| Change From Baseline in Sitting Systolic Blood Pressure at Week 26 - Full Analysis Set Excluding Rescue Approach | Baseline and Week 26 | Blood pressure measurements were taken after at least 5 minutes of rest. Three measurements were taken approximately 2 minutes apart with the triplicate set recorded. Excluding rescue approach excludes all data following the initiation of rescue, in order to avoid the confounding influence of the rescue therapy with open-label glimepiride. |
| Change From Baseline in 2-hour Post-Meal Glucose (PMG) at Week 26 - Full Analysis Set Excluding Rescue Approach | Baseline and Week 26 | Change from baseline at Week 26 is defined as 2-hour PMG at Week 26 minus 2-hour PMG at Week 0. Two-hour post-meal glucose was measured following a standard meal. Excluding rescue approach excludes all data following the initiation of rescue, in order to avoid the confounding influence of the rescue therapy with open-label glimepiride. |
| Percentage of Participants With HbA1C <7% (<53 mmol/Mol) at Week 26 | Week 26 | HbA1C is blood marker used to report average blood glucose levels over prolonged periods of time and is reported as a percentage (%). HbA1c represents the percentage of glycated hemoglobin. |
Participant flow
Recruitment details
A total of 96 sites received independent ethics committees/institutional review boards' approval and 66 sites in 9 countries enrolled at least 1 participant.
Pre-assignment details
The study included a 1-week screening period; an 8-week (or greater) antihyperglycemic agent (AHA) wash-off period; and a 2-week single-blind placebo run-in period.
Participants by arm
| Arm | Count |
|---|---|
| Ertugliflozin 5 mg + Sitagliptin 100 mg Ertugliflozin, 5 mg, administered orally, once daily for 26 weeks. Sitagliptin, 100 mg, administered orally, once daily for 26 weeks. Placebo to ertugliflozin, 10 mg, administered orally, once daily for 26 weeks. | 98 |
| Ertugliflozin 15 mg + Sitagliptin 100 mg Ertugliflozin, 15 mg, administered orally, once daily for 26 weeks. Sitagliptin, 100 mg, administered orally, once daily for 26 weeks. | 96 |
| Placebo Placebo to ertugliflozin, 5 mg and 10 mg, administered orally, once daily for 26 weeks. Placebo to sitagliptin, 100 mg, administered orally, once daily for 26 weeks. | 97 |
| Total | 291 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 | FG002 |
|---|---|---|---|---|
| Overall Study | Lost to Follow-up | 2 | 1 | 3 |
| Overall Study | Withdrawal by Subject | 0 | 0 | 3 |
Baseline characteristics
| Characteristic | Ertugliflozin 5 mg + Sitagliptin 100 mg | Ertugliflozin 15 mg + Sitagliptin 100 mg | Placebo | Total |
|---|---|---|---|---|
| Age, Continuous | 56.4 Years STANDARD_DEVIATION 9.3 | 56.1 Years STANDARD_DEVIATION 10.1 | 54.3 Years STANDARD_DEVIATION 10.3 | 55.6 Years STANDARD_DEVIATION 10 |
| Sex: Female, Male Female | 41 Participants | 43 Participants | 40 Participants | 124 Participants |
| Sex: Female, Male Male | 57 Participants | 53 Participants | 57 Participants | 167 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk | EG002 affected / at risk |
|---|---|---|---|
| deaths Total, all-cause mortality | — / — | — / — | — / — |
| other Total, other adverse events | 8 / 98 | 3 / 96 | 12 / 97 |
| serious Total, serious adverse events | 2 / 98 | 3 / 96 | 5 / 97 |
Outcome results
Primary
Change From Baseline in Hemoglobin A1C (HbA1C) at Week 26 - Full Analysis Set (FAS Population Excluding Rescue Approach
HbA1C is blood marker used to report average blood glucose levels over prolonged periods of time and is reported as a percentage (%). HbA1C represents the percentage of glycated hemoglobin. A negative number indicates a reduction in HbA1C level. Excluding rescue approach excludes all data following the initiation of rescue, in order to avoid the confounding influence of the rescue therapy with open-label glimepiride.
Time frame: Baseline and Week 26
Population: FAS population includes randomized participants who took at least 1 dose of study medication and had at least one assessment at or after baseline for the change from baseline in the Week 26 HbA1C endpoint.
| Arm | Measure | Value (LEAST_SQUARES_MEAN) |
|---|---|---|
| Ertugliflozin 5 mg + Sitagliptin 100 mg | Change From Baseline in Hemoglobin A1C (HbA1C) at Week 26 - Full Analysis Set (FAS Population Excluding Rescue Approach | -1.60 Percentage |
| Ertugliflozin 15 mg + Sitagliptin 100 mg | Change From Baseline in Hemoglobin A1C (HbA1C) at Week 26 - Full Analysis Set (FAS Population Excluding Rescue Approach | -1.68 Percentage |
| Placebo | Change From Baseline in Hemoglobin A1C (HbA1C) at Week 26 - Full Analysis Set (FAS Population Excluding Rescue Approach | -0.44 Percentage |
p-value: <0.00195% CI: [-1.49, -0.84]Constrained Longitudinal Data Analysis
p-value: <0.00195% CI: [-1.57, -0.91]Constrained Longitudinal Data Analysis
Primary
Percentage of Participants Who Discontinued Study Medication Due to an AE - All Participants as Treated Excluding Rescue Approach
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. Excluding rescue approach excludes all data following the initiation of rescue, in order to avoid the confounding influence of the rescue therapy with open-label glimepiride.
Time frame: Up to Week 26
Population: ASaT population consisted of all randomized participants who received at least one dose of a study drug.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Ertugliflozin 5 mg + Sitagliptin 100 mg | Percentage of Participants Who Discontinued Study Medication Due to an AE - All Participants as Treated Excluding Rescue Approach | 2.0 Percentage of Participants |
| Ertugliflozin 15 mg + Sitagliptin 100 mg | Percentage of Participants Who Discontinued Study Medication Due to an AE - All Participants as Treated Excluding Rescue Approach | 2.1 Percentage of Participants |
| Placebo | Percentage of Participants Who Discontinued Study Medication Due to an AE - All Participants as Treated Excluding Rescue Approach | 2.1 Percentage of Participants |
Primary
Percentage of Participants Who Experienced an Adverse Event (AE) - All Participants as Treated Excluding Rescue Approach
An adverse event (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. Excluding rescue approach excludes all data following the initiation of rescue, in order to avoid the confounding influence of the rescue therapy with open-label glimepiride.
Time frame: Up to Week 28
Population: All Subjects as Treated (ASaT) population consisted of all randomized participants who received at least one dose of a study drug.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Ertugliflozin 5 mg + Sitagliptin 100 mg | Percentage of Participants Who Experienced an Adverse Event (AE) - All Participants as Treated Excluding Rescue Approach | 44.9 Percentage of Participants |
| Ertugliflozin 15 mg + Sitagliptin 100 mg | Percentage of Participants Who Experienced an Adverse Event (AE) - All Participants as Treated Excluding Rescue Approach | 44.8 Percentage of Participants |
| Placebo | Percentage of Participants Who Experienced an Adverse Event (AE) - All Participants as Treated Excluding Rescue Approach | 42.3 Percentage of Participants |
95% CI: [-11.2, 16.4]
95% CI: [-11.4, 16.4]
Secondary
Change From Baseline in 2-hour Post-Meal Glucose (PMG) at Week 26 - Full Analysis Set Excluding Rescue Approach
Change from baseline at Week 26 is defined as 2-hour PMG at Week 26 minus 2-hour PMG at Week 0. Two-hour post-meal glucose was measured following a standard meal. Excluding rescue approach excludes all data following the initiation of rescue, in order to avoid the confounding influence of the rescue therapy with open-label glimepiride.
Time frame: Baseline and Week 26
Population: FAS population is all randomized participants who took at least 1 dose of study medication and had at least one assessment at or after baseline for the change from baseline in the Week 26 2-hour PMG endpoint.
| Arm | Measure | Value (LEAST_SQUARES_MEAN) |
|---|---|---|
| Ertugliflozin 5 mg + Sitagliptin 100 mg | Change From Baseline in 2-hour Post-Meal Glucose (PMG) at Week 26 - Full Analysis Set Excluding Rescue Approach | -82.80 milligrams/deciliter |
| Ertugliflozin 15 mg + Sitagliptin 100 mg | Change From Baseline in 2-hour Post-Meal Glucose (PMG) at Week 26 - Full Analysis Set Excluding Rescue Approach | -90.03 milligrams/deciliter |
| Placebo | Change From Baseline in 2-hour Post-Meal Glucose (PMG) at Week 26 - Full Analysis Set Excluding Rescue Approach | -20.38 milligrams/deciliter |
p-value: <0.00195% CI: [-80.47, -44.37]Constrained Longitudinal Data Analysis
p-value: <0.00195% CI: [-87.83, -51.46]Constrained Longitudinal Data Analysis
Secondary
Change From Baseline in Body Weight at Week 26 - Full Analysis Set Excluding Rescue Approach
Body weight was measured using a standardized, digital scale at each of the pre-defined nominal time points. Weight was taken in duplicate throughout the trial at approximately the same time of day, after voiding (i.e., forced void) and while wearing only a gown and underwear. Excluding rescue approach excludes all data following the initiation of rescue, in order to avoid the confounding influence of the rescue therapy with open-label glimepiride.
Time frame: Baseline and Week 26
Population: FAS population is all randomized participants who took at least 1 dose of study medication and had at least one assessment at or after baseline for the change from baseline in the Week 26 body weight endpoint.
| Arm | Measure | Value (LEAST_SQUARES_MEAN) |
|---|---|---|
| Ertugliflozin 5 mg + Sitagliptin 100 mg | Change From Baseline in Body Weight at Week 26 - Full Analysis Set Excluding Rescue Approach | -2.94 Kilograms |
| Ertugliflozin 15 mg + Sitagliptin 100 mg | Change From Baseline in Body Weight at Week 26 - Full Analysis Set Excluding Rescue Approach | -3.04 Kilograms |
| Placebo | Change From Baseline in Body Weight at Week 26 - Full Analysis Set Excluding Rescue Approach | -0.94 Kilograms |
p-value: <0.00195% CI: [-2.99, -1.01]Constrained Longitudinal Data Analysis
p-value: <0.00195% CI: [-3.1, -1.11]Constrained Longitudinal Data Analysis
Secondary
Change From Baseline in Fasting Plasma Glucose (FPG) at Week 26 - Full Analysis Set Excluding Rescue Approach
Blood glucose was measured after a ≥10 hour fast. Blood was drawn at predose on Day 1 and after 26 weeks of treatment to determine change in plasma glucose levels (i.e., FPG at Week 26 minus FPG at baseline). Excluding rescue approach excludes all data following the initiation of rescue, in order to avoid the confounding influence of the rescue therapy with open-label glimepiride.
Time frame: Baseline and Week 26
Population: FAS population includes randomized participants who took at least 1 dose of study medication and had at least one assessment at or after baseline for the change from baseline in the Week 26 FPG endpoint.
| Arm | Measure | Value (LEAST_SQUARES_MEAN) |
|---|---|---|
| Ertugliflozin 5 mg + Sitagliptin 100 mg | Change From Baseline in Fasting Plasma Glucose (FPG) at Week 26 - Full Analysis Set Excluding Rescue Approach | -48.25 milligrams/deciliter |
| Ertugliflozin 15 mg + Sitagliptin 100 mg | Change From Baseline in Fasting Plasma Glucose (FPG) at Week 26 - Full Analysis Set Excluding Rescue Approach | -55.36 milligrams/deciliter |
| Placebo | Change From Baseline in Fasting Plasma Glucose (FPG) at Week 26 - Full Analysis Set Excluding Rescue Approach | -9.30 milligrams/deciliter |
p-value: <0.00195% CI: [-49.93, -27.96]Constrained Longitudinal Data Analysis
p-value: <0.00195% CI: [-57.09, -35.02]Constrained Longitudinal Data Analysis
Secondary
Change From Baseline in Sitting Diastolic Blood Pressure at Week 26 - Full Analysis Set Excluding Rescue Approach
Blood pressure measurements were taken after at least 5 minutes of rest. Three measurements were taken approximately 2 minutes apart with the triplicate set recorded. Excluding rescue approach excludes all data following the initiation of rescue, in order to avoid the confounding influence of the rescue therapy with open-label glimepiride.
Time frame: Baseline and Week 26
Population: The FAS population included all randomized participants who took at least 1 dose of study medication and had at least one assessment at or after baseline for the change from baseline in the Week 26 sitting diastolic blood pressure endpoint.
| Arm | Measure | Value (LEAST_SQUARES_MEAN) |
|---|---|---|
| Ertugliflozin 5 mg + Sitagliptin 100 mg | Change From Baseline in Sitting Diastolic Blood Pressure at Week 26 - Full Analysis Set Excluding Rescue Approach | -0.44 millimeters of mercury |
| Ertugliflozin 15 mg + Sitagliptin 100 mg | Change From Baseline in Sitting Diastolic Blood Pressure at Week 26 - Full Analysis Set Excluding Rescue Approach | -0.97 millimeters of mercury |
| Placebo | Change From Baseline in Sitting Diastolic Blood Pressure at Week 26 - Full Analysis Set Excluding Rescue Approach | 1.21 millimeters of mercury |
p-value: 0.18495% CI: [-4.09, 0.79]Constrained Longitudinal Data Analysis
p-value: 0.0895% CI: [-4.62, 0.26]Constrained Longitudinal Data Analysis
Secondary
Change From Baseline in Sitting Systolic Blood Pressure at Week 26 - Full Analysis Set Excluding Rescue Approach
Blood pressure measurements were taken after at least 5 minutes of rest. Three measurements were taken approximately 2 minutes apart with the triplicate set recorded. Excluding rescue approach excludes all data following the initiation of rescue, in order to avoid the confounding influence of the rescue therapy with open-label glimepiride.
Time frame: Baseline and Week 26
Population: FAS population included all randomized participants who took at least 1 dose of study medication and had at least one assessment at or after baseline for the change from baseline in the Week 26 sitting systolic blood pressure endpoint.
| Arm | Measure | Value (LEAST_SQUARES_MEAN) |
|---|---|---|
| Ertugliflozin 5 mg + Sitagliptin 100 mg | Change From Baseline in Sitting Systolic Blood Pressure at Week 26 - Full Analysis Set Excluding Rescue Approach | -2.04 millimeters of mercury |
| Ertugliflozin 15 mg + Sitagliptin 100 mg | Change From Baseline in Sitting Systolic Blood Pressure at Week 26 - Full Analysis Set Excluding Rescue Approach | -3.98 millimeters of mercury |
| Placebo | Change From Baseline in Sitting Systolic Blood Pressure at Week 26 - Full Analysis Set Excluding Rescue Approach | 2.41 millimeters of mercury |
p-value: 0.01195% CI: [-7.87, -1.01]Constrained Longitudinal Data Analysis
p-value: <0.00195% CI: [-9.83, -2.95]Constrained Longitudinal Data Analysis
Secondary
Percentage of Participants With HbA1C <7% (<53 mmol/Mol) at Week 26
HbA1C is blood marker used to report average blood glucose levels over prolonged periods of time and is reported as a percentage (%). HbA1c represents the percentage of glycated hemoglobin.
Time frame: Week 26
Population: FAS population includes randomized participants who took at least 1 dose of study medication and had at least one assessment at or after baseline in the Week 26 HbA1C endpoint.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Ertugliflozin 5 mg + Sitagliptin 100 mg | Percentage of Participants With HbA1C <7% (<53 mmol/Mol) at Week 26 | 35.7 Percentage of participants |
| Ertugliflozin 15 mg + Sitagliptin 100 mg | Percentage of Participants With HbA1C <7% (<53 mmol/Mol) at Week 26 | 31.3 Percentage of participants |
| Placebo | Percentage of Participants With HbA1C <7% (<53 mmol/Mol) at Week 26 | 8.3 Percentage of participants |
p-value: <0.00195% CI: [2.81, 16.83]Logistic regression model
p-value: <0.00195% CI: [2.98, 18.31]Logistic regression model