Diabetes Mellitus, Type 2
Conditions
Keywords
Phase 2, safety and efficacy study with ertugliflozin (PF-04971729, MK-8835), Type 2 diabetes mellitus
Brief summary
MK-8835-016 (B1521006) is designed to evaluate the safety and efficacy of an investigational drug, ertugliflozin (MK-8835, PF-04971729) in participants with Type 2 diabetes mellitus. Participants in the study will receive 1 of 6 treatments for 12 weeks including 1 treatment with an approved drug (sitagliptin) for the treatment of Type 2 diabetes mellitus.
Interventions
Tablet(s), 1 or 2, matching placebo to 1-mg, 5-mg and/or 25-mg tablets, once daily for 84 days
Tablet, 1 mg, once daily for 84 days
Tablet(s), 1 or 2, 5-mg tablets once daily for 84 days
Tablet, 25 mg, once daily for 84 days
Tablet, 100 mg, once daily for 84 days
Tablet, matching placebo to 100 mg, once daily for 84 days
DRUGMetformin
Participants continued pre-study stable doses of metformin during the run-in and treatment periods of the study (maximum dose up to 2500 mg/day or 3000 mg/day where the maximum metformin dose per the local country product labels was 3000 mg/day).
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 70 Years
Healthy volunteers
No
Inclusion criteria
* Participants with type 2 diabetes on stable doses of background medicines for management of the diabetes; aged 18-70 years; body mass index between 23-45 kg/m\^2
Exclusion criteria
* Participants with type 1 diabetes, heart attack or stroke in last 6-months, uncontrolled blood pressure, significant kidney disease
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Baseline Hemoglobin A1c (HbA1c) | Baseline | HbA1c is measured as percent. |
| Change From Baseline in HbA1c at Week 12 | Baseline and Week 12 | HbA1c is measured as percent. The change from baseline is the Week 12 HbA1c percent minus the Week 0 HbA1c percent (last observation carried forward \[LOCF\]). |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Change From Baseline in HbA1c at Week 4 | Baseline and Week 4 | HbA1c is measured as percent. The change from baseline is the Week 4 HbA1c percent minus the Week 0 HbA1c percent (LOCF). |
| Change From Baseline in HbA1c at Week 8 | Baseline and Week 8 | HbA1c is measured as percent. The change from baseline is the Week 8 HbA1c percent minus the Week 0 HbA1c percent (LOCF). |
| Percent Change From Baseline in Body Weight at Week 12 | Baseline and Week 12 | The percent change from baseline is the (\[Week 12 body weight minus the Week 0 body weight\] divided by the Week 0 body weight) X 100 (LOCF). |
| Percent Change From Baseline in Body Weight at Week 2 | Baseline and Week 2 | The percent change from baseline is the (\[Week 2 body weight minus the Week 0 body weight\] divided by the Week 0 body weight) X 100 (LOCF). |
| Percent Change From Baseline in Body Weight at Week 4 | Baseline and Week 4 | The percent change from baseline is the (\[Week 4 body weight minus the Week 0 body weight\] divided by the Week 0 body weight) X 100 (LOCF). |
| Percent Change From Baseline in Body Weight at Week 8 | Baseline and Week 8 | The percent change from baseline is the (\[Week 8 body weight minus the Week 0 body weight\] divided by the Week 0 body weight) X 100 (LOCF). |
| Baseline Systolic Blood Pressure | Baseline | Sitting blood pressure was measured in triplicate and the average of the measurements taken at a single assessment time was analyzed. |
| Change From Baseline in Systolic Blood Pressure at Week 12 | Baseline and Week 12 | Sitting blood pressure was measured in triplicate and the average of the measurements taken at a single assessment time was analyzed. The change from baseline is the Week 12 systolic blood pressure minus the Week 0 systolic blood pressure (LOCF). |
| Change From Baseline in Systolic Blood Pressure at Week 2 | Baseline and Week 2 | Sitting blood pressure was measured in triplicate and the average of the measurements taken at a single assessment time was analyzed. The change from baseline is the Week 2 systolic blood pressure minus the Week 0 systolic blood pressure (LOCF). |
| Change From Baseline in Systolic Blood Pressure at Week 4 | Baseline and Week 4 | Sitting blood pressure was measured in triplicate and the average of the measurements taken at a single assessment time was analyzed. The change from baseline is the Week 4 systolic blood pressure minus the Week 0 systolic blood pressure (LOCF). |
| Change From Baseline in Systolic Blood Pressure at Week 8 | Baseline and Week 8 | Sitting blood pressure was measured in triplicate and the average of the measurements taken at a single assessment time was analyzed. The change from baseline is the Week 8 systolic blood pressure minus the Week 0 systolic blood pressure (LOCF). |
| Baseline Diastolic Blood Pressure | Baseline | Sitting blood pressure was measured in triplicate and the average of the measurements taken at a single assessment time was analyzed. |
| Baseline Body Weight | Baseline | — |
| Change From Baseline in Diastolic Blood Pressure at Week 2 | Baseline and Week 2 | Sitting blood pressure was measured in triplicate and the average of the measurements taken at a single assessment time was analyzed. The change from baseline is the Week 2 diastolic blood pressure minus the Week 0 diastolic blood pressure (LOCF). |
| Change From Baseline in Diastolic Blood Pressure at Week 4 | Baseline and Week 4 | Sitting blood pressure was measured in triplicate and the average of the measurements taken at a single assessment time was analyzed. The change from baseline is the Week 4 diastolic blood pressure minus the Week 0 diastolic blood pressure (LOCF). |
| Change From Baseline in Diastolic Blood Pressure at Week 8 | Baseline and Week 8 | Sitting blood pressure was measured in triplicate and the average of the measurements taken at a single assessment time was analyzed. The change from baseline is the Week 8 diastolic blood pressure minus the Week 0 diastolic blood pressure (LOCF). |
| Baseline Fasting Plasma Glucose | Baseline | Laboratory measurements were performed after an overnight fast ≥8 hours in duration. |
| Change From Baseline in Fasting Plasma Glucose at Week 12 | Baseline and Week 12 | The change from baseline is the Week 12 FPG minus the Week 0 fasting plasma glucose (LOCF). Laboratory measurements were performed after an overnight fast ≥8 hours in duration. |
| Change From Baseline in Fasting Plasma Glucose at Week 2 | Baseline and Week 2 | The change from baseline is the Week 2 FPG minus the Week 0 FPG (LOCF). Laboratory measurements were performed after an overnight fast ≥8 hours in duration. |
| Change From Baseline in Fasting Plasma Glucose at Week 4 | Baseline and Week 4 | The change from baseline is the Week 4 FPG minus the Week 0 FPG (LOCF). Laboratory measurements were performed after an overnight fast ≥8 hours in duration. |
| Change From Baseline in Fasting Plasma Glucose at Week 8 | Baseline and Week 8 | The change from baseline is the Week 8 FPG minus the Week 0 FPG (LOCF). Laboratory measurements were performed after an overnight fast ≥8 hours in duration. |
| Percentage of Participants Achieving HbA1c <7% at Week 12 | Week 12 | Laboratory measurements were performed after an overnight fast ≥8 hours in duration. |
| Percentage of Participants Achieving HbA1C <6.5% at Week 12 | Week 12 | Laboratory measurements were performed after an overnight fast ≥8 hours in duration. |
| Number of Participants Who Experienced an Advere Event (AE) | Up to 98 days | An adverse event is defines as any untoward medical occurrence in a clinical investigation participant administered a product or medical device; the event need not necessarily have a causal relationship with the treatment or usage. Below table includes all data collected since the first dose of sponsor-provided metformin. |
| Number of Participants Who Discontinued Study Medication Due to an AE | Up to 84 days | An adverse event is defines as any untoward medical occurrence in a clinical investigation participant administered a product or medical device; the event need not necessarily have a causal relationship with the treatment or usage. Below table includes all data collected since the first dose of sponsor-provided metformin and excludes a temporary discontinuation of study medication. |
| Change From Baseline in Diastolic Blood Pressure at Week 12 | Baseline and Week 12 | Sitting blood pressure was measured in triplicate and the average of the measurements taken at a single assessment time was analyzed. The change from baseline is the Week 12 diastolic blood pressure minus the Week 0 diastolic blood pressure (LOCF). |
| Change From Baseline in HbA1C at Week 2 | Baseline and Week 2 | HbA1c is measured as percent. The change from baseline is the Week 2 HbA1c percent minus the Week 0 HbA1c percent (LOCF). |
Participant flow
Pre-assignment details
Of the 375 enrolled participants included in the metformin run-in period, 328 participants were randomized to 1 of 6 treatment groups.
Participants by arm
| Arm | Count |
|---|---|
| Placebo Placebo for ertugliflozin (1 mg or 5 mg and 25 mg) and placebo to sitagliptin, oral, once daily for 84 days | 54 |
| Ertugliflozin 1 mg Ertugliflozin 1 mg, placebo for ertugliflozin (1 mg or 5 mg and 25 mg), and placebo to sitagliptin, oral, once daily for 84 days | 54 |
| Ertugliflozin 5 mg Ertugliflozin 5 mg, placebo for ertugliflozin (1 mg or 5 mg and 25 mg), and placebo to sitagliptin, oral, once daily for 84 days | 55 |
| Ertugliflozin 10 mg Ertugliflozin 10 mg, placebo for ertugliflozin (25 mg), and placebo to sitagliptin, oral, once daily for 84 days | 55 |
| Ertugliflozin 25 mg Ertugliflozin 25 mg, placebo for ertugliflozin (1 mg or 5 mg), and placebo to sitagliptin, oral, once daily for 84 days | 55 |
| Sitagliptin 100 mg Sitagliptin 100 mg, placebo for ertugliflozin (1 mg or 5 mg and 25 mg), oral, once daily for 84 days | 55 |
| Total | 328 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 | FG002 | FG003 | FG004 | FG005 | FG006 |
|---|---|---|---|---|---|---|---|---|
| Enrolled, Run-in Period | Adverse event not related to study drug | 0 | 0 | 0 | 0 | 0 | 0 | 3 |
| Enrolled, Run-in Period | Did not meet entrance criteria | 0 | 0 | 0 | 0 | 0 | 0 | 14 |
| Enrolled, Run-in Period | Lost to Follow-up | 0 | 0 | 0 | 0 | 0 | 0 | 5 |
| Enrolled, Run-in Period | Other reason not specified | 0 | 0 | 0 | 0 | 0 | 0 | 7 |
| Enrolled, Run-in Period | Protocol Violation | 0 | 0 | 0 | 0 | 0 | 0 | 5 |
| Enrolled, Run-in Period | Withdrawal by Subject | 0 | 0 | 0 | 0 | 0 | 0 | 13 |
| Treatment Period | Adverse event not related to study drug | 0 | 1 | 2 | 1 | 1 | 1 | 0 |
| Treatment Period | Adverse event related to study drug | 1 | 0 | 1 | 1 | 0 | 0 | 0 |
| Treatment Period | Insufficient clinical response | 3 | 0 | 0 | 0 | 0 | 0 | 0 |
| Treatment Period | Lost to Follow-up | 2 | 1 | 0 | 1 | 2 | 0 | 0 |
| Treatment Period | Other reason not specified | 1 | 2 | 1 | 2 | 0 | 0 | 0 |
| Treatment Period | Protocol Violation | 0 | 0 | 1 | 1 | 1 | 1 | 0 |
| Treatment Period | Withdrawal by Subject | 3 | 0 | 1 | 5 | 4 | 1 | 0 |
Baseline characteristics
| Characteristic | Placebo | Ertugliflozin 1 mg | Ertugliflozin 5 mg | Ertugliflozin 10 mg | Ertugliflozin 25 mg | Sitagliptin 100 mg | Total |
|---|---|---|---|---|---|---|---|
| Age, Customized 18-44 years | 8 Participants | 10 Participants | 6 Participants | 1 Participants | 9 Participants | 13 Participants | 47 Participants |
| Age, Customized < 18 years | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Age, Customized 45-64 years | 41 Participants | 36 Participants | 42 Participants | 47 Participants | 39 Participants | 33 Participants | 238 Participants |
| Age, Customized >= 65 years | 5 Participants | 8 Participants | 7 Participants | 7 Participants | 7 Participants | 9 Participants | 43 Participants |
| Sex: Female, Male Female | 24 Participants | 20 Participants | 14 Participants | 24 Participants | 18 Participants | 15 Participants | 115 Participants |
| Sex: Female, Male Male | 30 Participants | 34 Participants | 41 Participants | 31 Participants | 37 Participants | 40 Participants | 213 Participants |
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 |
|---|---|---|---|---|---|---|---|
| deaths Total, all-cause mortality | — / — | — / — | — / — | — / — | — / — | — / — | — / — |
| other Total, other adverse events | 13 / 54 | 10 / 54 | 14 / 55 | 14 / 55 | 10 / 55 | 12 / 55 | 30 / 375 |
| serious Total, serious adverse events | 0 / 54 | 0 / 54 | 2 / 55 | 0 / 55 | 1 / 55 | 1 / 55 | 2 / 375 |
Outcome results
Primary
Baseline Hemoglobin A1c (HbA1c)
HbA1c is measured as percent.
Time frame: Baseline
Population: All randomized participants.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Placebo | Baseline Hemoglobin A1c (HbA1c) | 8.08 Percent | Standard Error 0.14 |
| Ertugliflozin 1 mg | Baseline Hemoglobin A1c (HbA1c) | 8.01 Percent | Standard Error 0.17 |
| Ertugliflozin 5 mg | Baseline Hemoglobin A1c (HbA1c) | 7.88 Percent | Standard Error 0.13 |
| Ertugliflozin 10 mg | Baseline Hemoglobin A1c (HbA1c) | 8.13 Percent | Standard Error 0.17 |
| Ertugliflozin 25 mg | Baseline Hemoglobin A1c (HbA1c) | 8.30 Percent | Standard Error 0.16 |
| Sitagliptin 100 mg | Baseline Hemoglobin A1c (HbA1c) | 8.24 Percent | Standard Error 0.15 |
Primary
Change From Baseline in HbA1c at Week 12
HbA1c is measured as percent. The change from baseline is the Week 12 HbA1c percent minus the Week 0 HbA1c percent (last observation carried forward \[LOCF\]).
Time frame: Baseline and Week 12
Population: Analysis population included randomized participants who were treated, had a baseline HbA1c measurement and at least 1 post-baseline HbA1c measurement up to Week 12.
| Arm | Measure | Value (LEAST_SQUARES_MEAN) |
|---|---|---|
| Placebo | Change From Baseline in HbA1c at Week 12 | -0.11 Percent |
| Ertugliflozin 1 mg | Change From Baseline in HbA1c at Week 12 | -0.56 Percent |
| Ertugliflozin 5 mg | Change From Baseline in HbA1c at Week 12 | -0.80 Percent |
| Ertugliflozin 10 mg | Change From Baseline in HbA1c at Week 12 | -0.73 Percent |
| Ertugliflozin 25 mg | Change From Baseline in HbA1c at Week 12 | -0.83 Percent |
| Sitagliptin 100 mg | Change From Baseline in HbA1c at Week 12 | -0.87 Percent |
Comparison: The null hypothesis is that there is no difference between ertugliflozin and placebo on the primary endpoint.p-value: 0.00280% CI: [-0.65, -0.25]ANCOVA
Comparison: The null hypothesis is that there is no difference between ertugliflozin and placebo on the primary endpoint.p-value: 080% CI: [-0.89, -0.49]ANCOVA
Comparison: The null hypothesis is that there is no difference between ertugliflozin and placebo on the primary endpoint.p-value: 080% CI: [-0.82, -0.42]ANCOVA
Comparison: The null hypothesis is that there is no difference between ertugliflozin and placebo on the primary endpoint.p-value: 080% CI: [-0.93, -0.52]ANCOVA
p-value: 080% CI: [-0.97, -0.56]ANCOVA
Secondary
Baseline Body Weight
Time frame: Baseline
Population: All randomized participants.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Placebo | Baseline Body Weight | 83.78 kg | Standard Error 2.37 |
| Ertugliflozin 1 mg | Baseline Body Weight | 83.44 kg | Standard Error 2.57 |
| Ertugliflozin 5 mg | Baseline Body Weight | 85.74 kg | Standard Error 2.82 |
| Ertugliflozin 10 mg | Baseline Body Weight | 82.28 kg | Standard Error 2.93 |
| Ertugliflozin 25 mg | Baseline Body Weight | 81.81 kg | Standard Error 2.34 |
| Sitagliptin 100 mg | Baseline Body Weight | 85.52 kg | Standard Error 2.61 |
Secondary
Baseline Diastolic Blood Pressure
Sitting blood pressure was measured in triplicate and the average of the measurements taken at a single assessment time was analyzed.
Time frame: Baseline
Population: All randomized participants.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Placebo | Baseline Diastolic Blood Pressure | 79.14 mmHg | Standard Error 1.24 |
| Ertugliflozin 1 mg | Baseline Diastolic Blood Pressure | 78.95 mmHg | Standard Error 1.14 |
| Ertugliflozin 5 mg | Baseline Diastolic Blood Pressure | 78.19 mmHg | Standard Error 1.36 |
| Ertugliflozin 10 mg | Baseline Diastolic Blood Pressure | 78.45 mmHg | Standard Error 1.32 |
| Ertugliflozin 25 mg | Baseline Diastolic Blood Pressure | 78.61 mmHg | Standard Error 1.24 |
| Sitagliptin 100 mg | Baseline Diastolic Blood Pressure | 79.15 mmHg | Standard Error 1.01 |
Secondary
Baseline Fasting Plasma Glucose
Laboratory measurements were performed after an overnight fast ≥8 hours in duration.
Time frame: Baseline
Population: All randomized participants.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Placebo | Baseline Fasting Plasma Glucose | 165.3 mg/dL | Standard Error 5.65 |
| Ertugliflozin 1 mg | Baseline Fasting Plasma Glucose | 162.5 mg/dL | Standard Error 6.75 |
| Ertugliflozin 5 mg | Baseline Fasting Plasma Glucose | 156.5 mg/dL | Standard Error 5.79 |
| Ertugliflozin 10 mg | Baseline Fasting Plasma Glucose | 163.3 mg/dL | Standard Error 6.3 |
| Ertugliflozin 25 mg | Baseline Fasting Plasma Glucose | 171.3 mg/dL | Standard Error 7.69 |
| Sitagliptin 100 mg | Baseline Fasting Plasma Glucose | 166.2 mg/dL | Standard Error 6.7 |
Secondary
Baseline Systolic Blood Pressure
Sitting blood pressure was measured in triplicate and the average of the measurements taken at a single assessment time was analyzed.
Time frame: Baseline
Population: All randomized participants.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Placebo | Baseline Systolic Blood Pressure | 126.7 mmHg | Standard Error 1.71 |
| Ertugliflozin 1 mg | Baseline Systolic Blood Pressure | 126.5 mmHg | Standard Error 2.18 |
| Ertugliflozin 5 mg | Baseline Systolic Blood Pressure | 127.9 mmHg | Standard Error 2.31 |
| Ertugliflozin 10 mg | Baseline Systolic Blood Pressure | 125.8 mmHg | Standard Error 1.97 |
| Ertugliflozin 25 mg | Baseline Systolic Blood Pressure | 124.9 mmHg | Standard Error 2.2 |
| Sitagliptin 100 mg | Baseline Systolic Blood Pressure | 126.6 mmHg | Standard Error 1.83 |
Secondary
Change From Baseline in Diastolic Blood Pressure at Week 12
Sitting blood pressure was measured in triplicate and the average of the measurements taken at a single assessment time was analyzed. The change from baseline is the Week 12 diastolic blood pressure minus the Week 0 diastolic blood pressure (LOCF).
Time frame: Baseline and Week 12
Population: Analysis population included randomized participants who were treated, had a baseline diastolic blood pressure measurement and at least 1 post-baseline diastolic blood pressure measurement up to Week 12.
| Arm | Measure | Value (LEAST_SQUARES_MEAN) |
|---|---|---|
| Placebo | Change From Baseline in Diastolic Blood Pressure at Week 12 | 0.81 mmHg |
| Ertugliflozin 1 mg | Change From Baseline in Diastolic Blood Pressure at Week 12 | -1.12 mmHg |
| Ertugliflozin 5 mg | Change From Baseline in Diastolic Blood Pressure at Week 12 | -1.01 mmHg |
| Ertugliflozin 10 mg | Change From Baseline in Diastolic Blood Pressure at Week 12 | -3.18 mmHg |
| Ertugliflozin 25 mg | Change From Baseline in Diastolic Blood Pressure at Week 12 | -1.83 mmHg |
| Sitagliptin 100 mg | Change From Baseline in Diastolic Blood Pressure at Week 12 | 1.68 mmHg |
p-value: 0.07280% CI: [-3.62, -0.24]ANCOVA
p-value: 0.08680% CI: [-3.51, -0.11]ANCOVA
p-value: 0.00280% CI: [-5.71, -2.27]ANCOVA
p-value: 0.02580% CI: [-4.37, -0.92]ANCOVA
p-value: 0.74680% CI: [-0.82, 2.58]ANCOVA
Secondary
Change From Baseline in Diastolic Blood Pressure at Week 2
Sitting blood pressure was measured in triplicate and the average of the measurements taken at a single assessment time was analyzed. The change from baseline is the Week 2 diastolic blood pressure minus the Week 0 diastolic blood pressure (LOCF).
Time frame: Baseline and Week 2
Population: Analysis population included randomized participants who were treated, had a baseline diastolic blood pressure measurement and at least 1 post-baseline diastolic blood pressure measurement up to Week 2.
| Arm | Measure | Value (LEAST_SQUARES_MEAN) |
|---|---|---|
| Placebo | Change From Baseline in Diastolic Blood Pressure at Week 2 | -0.57 mmHg |
| Ertugliflozin 1 mg | Change From Baseline in Diastolic Blood Pressure at Week 2 | -1.25 mmHg |
| Ertugliflozin 5 mg | Change From Baseline in Diastolic Blood Pressure at Week 2 | -1.26 mmHg |
| Ertugliflozin 10 mg | Change From Baseline in Diastolic Blood Pressure at Week 2 | -1.97 mmHg |
| Ertugliflozin 25 mg | Change From Baseline in Diastolic Blood Pressure at Week 2 | -3.01 mmHg |
| Sitagliptin 100 mg | Change From Baseline in Diastolic Blood Pressure at Week 2 | 0.92 mmHg |
p-value: 0.28980% CI: [-2.27, 0.9]ANCOVA
p-value: 0.28880% CI: [-2.31, 0.91]ANCOVA
p-value: 0.1380% CI: [-3.01, 0.19]ANCOVA
p-value: 0.02680% CI: [-4.05, -0.84]ANCOVA
p-value: 0.88380% CI: [-0.11, 3.08]ANCOVA
Secondary
Change From Baseline in Diastolic Blood Pressure at Week 4
Sitting blood pressure was measured in triplicate and the average of the measurements taken at a single assessment time was analyzed. The change from baseline is the Week 4 diastolic blood pressure minus the Week 0 diastolic blood pressure (LOCF).
Time frame: Baseline and Week 4
Population: Analysis population included randomized participants who were treated, had a baseline diastolic blood pressure measurement and at least 1 post-baseline diastolic blood pressure measurement up to Week 4.
| Arm | Measure | Value (LEAST_SQUARES_MEAN) |
|---|---|---|
| Placebo | Change From Baseline in Diastolic Blood Pressure at Week 4 | -0.80 mmHg |
| Ertugliflozin 1 mg | Change From Baseline in Diastolic Blood Pressure at Week 4 | -2.47 mmHg |
| Ertugliflozin 5 mg | Change From Baseline in Diastolic Blood Pressure at Week 4 | -3.08 mmHg |
| Ertugliflozin 10 mg | Change From Baseline in Diastolic Blood Pressure at Week 4 | -2.81 mmHg |
| Ertugliflozin 25 mg | Change From Baseline in Diastolic Blood Pressure at Week 4 | -2.10 mmHg |
| Sitagliptin 100 mg | Change From Baseline in Diastolic Blood Pressure at Week 4 | -0.51 mmHg |
p-value: 0.06380% CI: [-3.07, -0.27]ANCOVA
p-value: 0.01980% CI: [-3.69, -0.88]ANCOVA
p-value: 0.03580% CI: [-3.43, -0.59]ANCOVA
p-value: 0.12180% CI: [-2.73, 0.12]ANCOVA
p-value: 0.60280% CI: [-1.13, 1.7]ANCOVA
Secondary
Change From Baseline in Diastolic Blood Pressure at Week 8
Sitting blood pressure was measured in triplicate and the average of the measurements taken at a single assessment time was analyzed. The change from baseline is the Week 8 diastolic blood pressure minus the Week 0 diastolic blood pressure (LOCF).
Time frame: Baseline and Week 8
Population: Analysis population included randomized participants who were treated, had a baseline diastolic blood pressure measurement and at least 1 post-baseline diastolic blood pressure measurement up to Week 8.
| Arm | Measure | Value (LEAST_SQUARES_MEAN) |
|---|---|---|
| Placebo | Change From Baseline in Diastolic Blood Pressure at Week 8 | 0.80 mmHg |
| Ertugliflozin 1 mg | Change From Baseline in Diastolic Blood Pressure at Week 8 | -1.40 mmHg |
| Ertugliflozin 5 mg | Change From Baseline in Diastolic Blood Pressure at Week 8 | -0.69 mmHg |
| Ertugliflozin 10 mg | Change From Baseline in Diastolic Blood Pressure at Week 8 | -2.23 mmHg |
| Ertugliflozin 25 mg | Change From Baseline in Diastolic Blood Pressure at Week 8 | -1.20 mmHg |
| Sitagliptin 100 mg | Change From Baseline in Diastolic Blood Pressure at Week 8 | 0.32 mmHg |
p-value: 0.04580% CI: [-3.86, -0.54]ANCOVA
p-value: 0.12680% CI: [-3.16, 0.18]ANCOVA
p-value: 0.01180% CI: [-4.72, -1.34]ANCOVA
p-value: 0.06680% CI: [-3.69, -0.3]ANCOVA
p-value: 0.35780% CI: [-2.15, 1.19]ANCOVA
Secondary
Change From Baseline in Fasting Plasma Glucose at Week 12
The change from baseline is the Week 12 FPG minus the Week 0 fasting plasma glucose (LOCF). Laboratory measurements were performed after an overnight fast ≥8 hours in duration.
Time frame: Baseline and Week 12
Population: Analysis population included randomized participants who were treated, had a baseline fasting plasma glucose measurement and at least 1 post-baseline fasting plasma glucose measurement up to Week 12.
| Arm | Measure | Value (LEAST_SQUARES_MEAN) |
|---|---|---|
| Placebo | Change From Baseline in Fasting Plasma Glucose at Week 12 | 2.76 mg/dL |
| Ertugliflozin 1 mg | Change From Baseline in Fasting Plasma Glucose at Week 12 | -18.23 mg/dL |
| Ertugliflozin 5 mg | Change From Baseline in Fasting Plasma Glucose at Week 12 | -23.06 mg/dL |
| Ertugliflozin 10 mg | Change From Baseline in Fasting Plasma Glucose at Week 12 | -31.47 mg/dL |
| Ertugliflozin 25 mg | Change From Baseline in Fasting Plasma Glucose at Week 12 | -29.26 mg/dL |
| Sitagliptin 100 mg | Change From Baseline in Fasting Plasma Glucose at Week 12 | -17.29 mg/dL |
p-value: 080% CI: [-28.29, -13.69]ANCOVA
p-value: 080% CI: [-33.17, -18.47]ANCOVA
p-value: 080% CI: [-41.64, -26.83]ANCOVA
p-value: 080% CI: [-39.49, -24.56]ANCOVA
p-value: 080% CI: [-27.39, -12.72]ANCOVA
Secondary
Change From Baseline in Fasting Plasma Glucose at Week 2
The change from baseline is the Week 2 FPG minus the Week 0 FPG (LOCF). Laboratory measurements were performed after an overnight fast ≥8 hours in duration.
Time frame: Baseline and Week 2
Population: Analysis population included randomized participants who were treated, had a baseline fasting plasma glucose measurement and at least 1 post-baseline fasting plasma glucose measurement up to Week 2.
| Arm | Measure | Value (LEAST_SQUARES_MEAN) |
|---|---|---|
| Placebo | Change From Baseline in Fasting Plasma Glucose at Week 2 | 5.89 mg/dL |
| Ertugliflozin 1 mg | Change From Baseline in Fasting Plasma Glucose at Week 2 | -15.07 mg/dL |
| Ertugliflozin 5 mg | Change From Baseline in Fasting Plasma Glucose at Week 2 | -15.68 mg/dL |
| Ertugliflozin 10 mg | Change From Baseline in Fasting Plasma Glucose at Week 2 | -26.65 mg/dL |
| Ertugliflozin 25 mg | Change From Baseline in Fasting Plasma Glucose at Week 2 | -16.44 mg/dL |
| Sitagliptin 100 mg | Change From Baseline in Fasting Plasma Glucose at Week 2 | -14.69 mg/dL |
p-value: 080% CI: [-28.58, -13.34]ANCOVA
p-value: 080% CI: [-29.27, -13.86]ANCOVA
p-value: 080% CI: [-40.2, -24.88]ANCOVA
p-value: 080% CI: [-30.05, -14.61]ANCOVA
p-value: 080% CI: [-28.19, -12.96]ANCOVA
Secondary
Change From Baseline in Fasting Plasma Glucose at Week 4
The change from baseline is the Week 4 FPG minus the Week 0 FPG (LOCF). Laboratory measurements were performed after an overnight fast ≥8 hours in duration.
Time frame: Baseline and Week 4
Population: Analysis population included randomized participants who were treated, had a baseline fasting plasma glucose measurement and at least 1 post-baseline fasting plasma glucose measurement up to Week 4.
| Arm | Measure | Value (LEAST_SQUARES_MEAN) |
|---|---|---|
| Placebo | Change From Baseline in Fasting Plasma Glucose at Week 4 | 5.17 mg/dL |
| Ertugliflozin 1 mg | Change From Baseline in Fasting Plasma Glucose at Week 4 | -16.91 mg/dL |
| Ertugliflozin 5 mg | Change From Baseline in Fasting Plasma Glucose at Week 4 | -22.77 mg/dL |
| Ertugliflozin 10 mg | Change From Baseline in Fasting Plasma Glucose at Week 4 | -27.95 mg/dL |
| Ertugliflozin 25 mg | Change From Baseline in Fasting Plasma Glucose at Week 4 | -26.62 mg/dL |
| Sitagliptin 100 mg | Change From Baseline in Fasting Plasma Glucose at Week 4 | -18.00 mg/dL |
p-value: 080% CI: [-29.16, -15.01]ANCOVA
p-value: 080% CI: [-35.06, -20.83]ANCOVA
p-value: 080% CI: [-40.29, -25.95]ANCOVA
p-value: 080% CI: [-39.02, -24.56]ANCOVA
p-value: 080% CI: [-30.28, -16.07]ANCOVA
Secondary
Change From Baseline in Fasting Plasma Glucose at Week 8
The change from baseline is the Week 8 FPG minus the Week 0 FPG (LOCF). Laboratory measurements were performed after an overnight fast ≥8 hours in duration.
Time frame: Baseline and Week 8
Population: Analysis population included randomized participants who were treated, had a baseline fasting plasma glucose measurement and at least 1 post-baseline fasting plasma glucose measurement up to Week 8.
| Arm | Measure | Value (LEAST_SQUARES_MEAN) |
|---|---|---|
| Placebo | Change From Baseline in Fasting Plasma Glucose at Week 8 | 3.82 mg/dL |
| Ertugliflozin 1 mg | Change From Baseline in Fasting Plasma Glucose at Week 8 | -18.25 mg/dL |
| Ertugliflozin 5 mg | Change From Baseline in Fasting Plasma Glucose at Week 8 | -24.69 mg/dL |
| Ertugliflozin 10 mg | Change From Baseline in Fasting Plasma Glucose at Week 8 | -31.59 mg/dL |
| Ertugliflozin 25 mg | Change From Baseline in Fasting Plasma Glucose at Week 8 | -30.99 mg/dL |
| Sitagliptin 100 mg | Change From Baseline in Fasting Plasma Glucose at Week 8 | -18.93 mg/dL |
p-value: 080% CI: [-28.87, -15.27]ANCOVA
p-value: 080% CI: [-35.35, -21.67]ANCOVA
p-value: 080% CI: [-42.3, -28.51]ANCOVA
p-value: 080% CI: [-41.76, -27.86]ANCOVA
p-value: 080% CI: [-29.58, -15.92]ANCOVA
Secondary
Change From Baseline in HbA1C at Week 2
HbA1c is measured as percent. The change from baseline is the Week 2 HbA1c percent minus the Week 0 HbA1c percent (LOCF).
Time frame: Baseline and Week 2
Population: Analysis population included randomized participants who were treated, had a baseline HbA1c measurement and at least 1 post-baseline HbA1c measurement up to Week 2.
| Arm | Measure | Value (LEAST_SQUARES_MEAN) |
|---|---|---|
| Placebo | Change From Baseline in HbA1C at Week 2 | 0.00 Percent |
| Ertugliflozin 1 mg | Change From Baseline in HbA1C at Week 2 | -0.14 Percent |
| Ertugliflozin 5 mg | Change From Baseline in HbA1C at Week 2 | -0.29 Percent |
| Ertugliflozin 10 mg | Change From Baseline in HbA1C at Week 2 | -0.22 Percent |
| Ertugliflozin 25 mg | Change From Baseline in HbA1C at Week 2 | -0.17 Percent |
| Sitagliptin 100 mg | Change From Baseline in HbA1C at Week 2 | -0.26 Percent |
p-value: 0.04980% CI: [-0.24, -0.03]ANCOVA
p-value: 080% CI: [-0.39, -0.18]ANCOVA
p-value: 0.00480% CI: [-0.32, -0.11]ANCOVA
p-value: 0.0280% CI: [-0.27, -0.06]ANCOVA
p-value: 0.00180% CI: [-0.36, -0.15]ANCOVA
Secondary
Change From Baseline in HbA1c at Week 4
HbA1c is measured as percent. The change from baseline is the Week 4 HbA1c percent minus the Week 0 HbA1c percent (LOCF).
Time frame: Baseline and Week 4
Population: Analysis population included randomized participants who were treated, had a baseline HbA1c measurement and at least 1 post-baseline HbA1c measurement up to Week 4.
| Arm | Measure | Value (LEAST_SQUARES_MEAN) |
|---|---|---|
| Placebo | Change From Baseline in HbA1c at Week 4 | -0.04 Percent |
| Ertugliflozin 1 mg | Change From Baseline in HbA1c at Week 4 | -0.40 Percent |
| Ertugliflozin 5 mg | Change From Baseline in HbA1c at Week 4 | -0.49 Percent |
| Ertugliflozin 10 mg | Change From Baseline in HbA1c at Week 4 | -0.48 Percent |
| Ertugliflozin 25 mg | Change From Baseline in HbA1c at Week 4 | -0.40 Percent |
| Sitagliptin 100 mg | Change From Baseline in HbA1c at Week 4 | -0.48 Percent |
p-value: 080% CI: [-0.5, -0.23]ANCOVA
p-value: 080% CI: [-0.59, -0.32]ANCOVA
p-value: 080% CI: [-0.57, -0.3]ANCOVA
p-value: 080% CI: [-0.49, -0.22]ANCOVA
p-value: 080% CI: [-0.57, -0.3]ANCOVA
Secondary
Change From Baseline in HbA1c at Week 8
HbA1c is measured as percent. The change from baseline is the Week 8 HbA1c percent minus the Week 0 HbA1c percent (LOCF).
Time frame: Baseline and Week 8
Population: Analysis population included randomized participants who were treated, had a baseline HbA1c measurement and at least 1 post-baseline HbA1c measurement up to Week 8.
| Arm | Measure | Value (LEAST_SQUARES_MEAN) |
|---|---|---|
| Placebo | Change From Baseline in HbA1c at Week 8 | -0.10 Percent |
| Ertugliflozin 1 mg | Change From Baseline in HbA1c at Week 8 | -0.57 Percent |
| Ertugliflozin 5 mg | Change From Baseline in HbA1c at Week 8 | -0.76 Percent |
| Ertugliflozin 10 mg | Change From Baseline in HbA1c at Week 8 | -0.73 Percent |
| Ertugliflozin 25 mg | Change From Baseline in HbA1c at Week 8 | -0.75 Percent |
| Sitagliptin 100 mg | Change From Baseline in HbA1c at Week 8 | -0.77 Percent |
p-value: 080% CI: [-0.64, -0.3]ANCOVA
p-value: 080% CI: [-0.83, -0.49]ANCOVA
p-value: 080% CI: [-0.8, -0.45]ANCOVA
p-value: 080% CI: [-0.82, -0.47]ANCOVA
p-value: 080% CI: [-0.84, -0.5]ANCOVA
Secondary
Change From Baseline in Systolic Blood Pressure at Week 12
Sitting blood pressure was measured in triplicate and the average of the measurements taken at a single assessment time was analyzed. The change from baseline is the Week 12 systolic blood pressure minus the Week 0 systolic blood pressure (LOCF).
Time frame: Baseline and Week 12
Population: Analysis population included randomized participants who were treated, had a baseline systolic blood pressure measurement and at least 1 post-baseline systolic blood pressure measurement up to Week 12.
| Arm | Measure | Value (LEAST_SQUARES_MEAN) |
|---|---|---|
| Placebo | Change From Baseline in Systolic Blood Pressure at Week 12 | -0.55 mmHg |
| Ertugliflozin 1 mg | Change From Baseline in Systolic Blood Pressure at Week 12 | -2.69 mmHg |
| Ertugliflozin 5 mg | Change From Baseline in Systolic Blood Pressure at Week 12 | -4.03 mmHg |
| Ertugliflozin 10 mg | Change From Baseline in Systolic Blood Pressure at Week 12 | -3.43 mmHg |
| Ertugliflozin 25 mg | Change From Baseline in Systolic Blood Pressure at Week 12 | -3.93 mmHg |
| Sitagliptin 100 mg | Change From Baseline in Systolic Blood Pressure at Week 12 | -1.09 mmHg |
p-value: 0.16380% CI: [-4.92, 0.65]ANCOVA
p-value: 0.05680% CI: [-6.28, -0.68]ANCOVA
p-value: 0.09680% CI: [-5.7, -0.05]ANCOVA
p-value: 0.06480% CI: [-6.21, -0.53]ANCOVA
p-value: 0.40380% CI: [-3.33, 2.26]ANCOVA
Secondary
Change From Baseline in Systolic Blood Pressure at Week 2
Sitting blood pressure was measured in triplicate and the average of the measurements taken at a single assessment time was analyzed. The change from baseline is the Week 2 systolic blood pressure minus the Week 0 systolic blood pressure (LOCF).
Time frame: Baseline and Week 2
Population: Analysis population included randomized participants who were treated, had a baseline systolic blood pressure measurement and at least 1 post-baseline systolic blood pressure measurement up to Week 2.
| Arm | Measure | Value (LEAST_SQUARES_MEAN) |
|---|---|---|
| Placebo | Change From Baseline in Systolic Blood Pressure at Week 2 | -1.93 mmHg |
| Ertugliflozin 1 mg | Change From Baseline in Systolic Blood Pressure at Week 2 | -2.30 mmHg |
| Ertugliflozin 5 mg | Change From Baseline in Systolic Blood Pressure at Week 2 | -4.73 mmHg |
| Ertugliflozin 10 mg | Change From Baseline in Systolic Blood Pressure at Week 2 | -2.28 mmHg |
| Ertugliflozin 25 mg | Change From Baseline in Systolic Blood Pressure at Week 2 | -5.39 mmHg |
| Sitagliptin 100 mg | Change From Baseline in Systolic Blood Pressure at Week 2 | -0.91 mmHg |
p-value: 0.42580% CI: [-2.91, 2.17]ANCOVA
p-value: 0.08280% CI: [-5.38, -0.23]ANCOVA
p-value: 0.4380% CI: [-2.92, 2.21]ANCOVA
p-value: 0.04380% CI: [-6.05, -0.89]ANCOVA
p-value: 0.69480% CI: [-1.55, 3.58]ANCOVA
Secondary
Change From Baseline in Systolic Blood Pressure at Week 4
Sitting blood pressure was measured in triplicate and the average of the measurements taken at a single assessment time was analyzed. The change from baseline is the Week 4 systolic blood pressure minus the Week 0 systolic blood pressure (LOCF).
Time frame: Baseline and Week 4
Population: Analysis population included randomized participants who were treated, had a baseline systolic blood pressure measurement and at least 1 post-baseline systolic blood pressure measurement up to Week 4.
| Arm | Measure | Value (LEAST_SQUARES_MEAN) |
|---|---|---|
| Placebo | Change From Baseline in Systolic Blood Pressure at Week 4 | -2.57 mmHg |
| Ertugliflozin 1 mg | Change From Baseline in Systolic Blood Pressure at Week 4 | -3.94 mmHg |
| Ertugliflozin 5 mg | Change From Baseline in Systolic Blood Pressure at Week 4 | -5.15 mmHg |
| Ertugliflozin 10 mg | Change From Baseline in Systolic Blood Pressure at Week 4 | -5.43 mmHg |
| Ertugliflozin 25 mg | Change From Baseline in Systolic Blood Pressure at Week 4 | -3.33 mmHg |
| Sitagliptin 100 mg | Change From Baseline in Systolic Blood Pressure at Week 4 | -3.32 mmHg |
p-value: 0.23480% CI: [-3.81, 1.05]ANCOVA
p-value: 0.08780% CI: [-5.03, -0.14]ANCOVA
p-value: 0.06880% CI: [-5.33, -0.4]ANCOVA
p-value: 0.34680% CI: [-3.25, 1.71]ANCOVA
p-value: 0.34680% CI: [-3.21, 1.7]ANCOVA
Secondary
Change From Baseline in Systolic Blood Pressure at Week 8
Sitting blood pressure was measured in triplicate and the average of the measurements taken at a single assessment time was analyzed. The change from baseline is the Week 8 systolic blood pressure minus the Week 0 systolic blood pressure (LOCF).
Time frame: Baseline and Week 8
Population: Analysis population included randomized participants who were treated, had a baseline systolic blood pressure measurement and at least 1 post-baseline systolic blood pressure measurement up to Week 8.
| Arm | Measure | Value (LEAST_SQUARES_MEAN) |
|---|---|---|
| Placebo | Change From Baseline in Systolic Blood Pressure at Week 8 | -0.44 mmHg |
| Ertugliflozin 1 mg | Change From Baseline in Systolic Blood Pressure at Week 8 | -1.53 mmHg |
| Ertugliflozin 5 mg | Change From Baseline in Systolic Blood Pressure at Week 8 | -2.85 mmHg |
| Ertugliflozin 10 mg | Change From Baseline in Systolic Blood Pressure at Week 8 | -3.04 mmHg |
| Ertugliflozin 25 mg | Change From Baseline in Systolic Blood Pressure at Week 8 | -3.30 mmHg |
| Sitagliptin 100 mg | Change From Baseline in Systolic Blood Pressure at Week 8 | -2.43 mmHg |
p-value: 0.30680% CI: [-3.87, 1.67]ANCOVA
p-value: 0.13380% CI: [-5.19, 0.37]ANCOVA
p-value: 0.11780% CI: [-5.42, 0.2]ANCOVA
p-value: 0.09780% CI: [-5.69, -0.04]ANCOVA
p-value: 0.17980% CI: [-4.78, 0.79]ANCOVA
Secondary
Number of Participants Who Discontinued Study Medication Due to an AE
An adverse event is defines as any untoward medical occurrence in a clinical investigation participant administered a product or medical device; the event need not necessarily have a causal relationship with the treatment or usage. Below table includes all data collected since the first dose of sponsor-provided metformin and excludes a temporary discontinuation of study medication.
Time frame: Up to 84 days
Population: All participants who received at least 1 dose of treatment (including sponsor-supplied metformin).
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Placebo | Number of Participants Who Discontinued Study Medication Due to an AE | 1 Participants |
| Ertugliflozin 1 mg | Number of Participants Who Discontinued Study Medication Due to an AE | 1 Participants |
| Ertugliflozin 5 mg | Number of Participants Who Discontinued Study Medication Due to an AE | 3 Participants |
| Ertugliflozin 10 mg | Number of Participants Who Discontinued Study Medication Due to an AE | 2 Participants |
| Ertugliflozin 25 mg | Number of Participants Who Discontinued Study Medication Due to an AE | 1 Participants |
| Sitagliptin 100 mg | Number of Participants Who Discontinued Study Medication Due to an AE | 1 Participants |
| Metformin Run-in | Number of Participants Who Discontinued Study Medication Due to an AE | 3 Participants |
Secondary
Number of Participants Who Experienced an Advere Event (AE)
An adverse event is defines as any untoward medical occurrence in a clinical investigation participant administered a product or medical device; the event need not necessarily have a causal relationship with the treatment or usage. Below table includes all data collected since the first dose of sponsor-provided metformin.
Time frame: Up to 98 days
Population: All participants who received at least 1 dose of treatment (including sponsor-supplied metformin).
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Placebo | Number of Participants Who Experienced an Advere Event (AE) | 29 Participants |
| Ertugliflozin 1 mg | Number of Participants Who Experienced an Advere Event (AE) | 31 Participants |
| Ertugliflozin 5 mg | Number of Participants Who Experienced an Advere Event (AE) | 30 Participants |
| Ertugliflozin 10 mg | Number of Participants Who Experienced an Advere Event (AE) | 29 Participants |
| Ertugliflozin 25 mg | Number of Participants Who Experienced an Advere Event (AE) | 28 Participants |
| Sitagliptin 100 mg | Number of Participants Who Experienced an Advere Event (AE) | 30 Participants |
| Metformin Run-in | Number of Participants Who Experienced an Advere Event (AE) | 82 Participants |
Secondary
Percentage of Participants Achieving HbA1C <6.5% at Week 12
Laboratory measurements were performed after an overnight fast ≥8 hours in duration.
Time frame: Week 12
Population: Analysis population excludes participants with missing Week 12 HbA1c measurement.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Placebo | Percentage of Participants Achieving HbA1C <6.5% at Week 12 | 6.7 Percentage of participants |
| Ertugliflozin 1 mg | Percentage of Participants Achieving HbA1C <6.5% at Week 12 | 12.0 Percentage of participants |
| Ertugliflozin 5 mg | Percentage of Participants Achieving HbA1C <6.5% at Week 12 | 20.4 Percentage of participants |
| Ertugliflozin 10 mg | Percentage of Participants Achieving HbA1C <6.5% at Week 12 | 13.6 Percentage of participants |
| Ertugliflozin 25 mg | Percentage of Participants Achieving HbA1C <6.5% at Week 12 | 14.9 Percentage of participants |
| Sitagliptin 100 mg | Percentage of Participants Achieving HbA1C <6.5% at Week 12 | 25.5 Percentage of participants |
Secondary
Percentage of Participants Achieving HbA1c <7% at Week 12
Laboratory measurements were performed after an overnight fast ≥8 hours in duration.
Time frame: Week 12
Population: Analysis population excludes participants with missing Week 12 HbA1c measurement.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Placebo | Percentage of Participants Achieving HbA1c <7% at Week 12 | 15.6 Percentage of participants |
| Ertugliflozin 1 mg | Percentage of Participants Achieving HbA1c <7% at Week 12 | 44.0 Percentage of participants |
| Ertugliflozin 5 mg | Percentage of Participants Achieving HbA1c <7% at Week 12 | 42.9 Percentage of participants |
| Ertugliflozin 10 mg | Percentage of Participants Achieving HbA1c <7% at Week 12 | 38.6 Percentage of participants |
| Ertugliflozin 25 mg | Percentage of Participants Achieving HbA1c <7% at Week 12 | 36.2 Percentage of participants |
| Sitagliptin 100 mg | Percentage of Participants Achieving HbA1c <7% at Week 12 | 43.1 Percentage of participants |
Secondary
Percent Change From Baseline in Body Weight at Week 12
The percent change from baseline is the (\[Week 12 body weight minus the Week 0 body weight\] divided by the Week 0 body weight) X 100 (LOCF).
Time frame: Baseline and Week 12
Population: Analysis population included randomized participants who were treated, had a baseline body weight measurement and at least 1 post-baseline body weight measurement up to Week 12.
| Arm | Measure | Value (LEAST_SQUARES_MEAN) |
|---|---|---|
| Placebo | Percent Change From Baseline in Body Weight at Week 12 | -0.75 Percent change |
| Ertugliflozin 1 mg | Percent Change From Baseline in Body Weight at Week 12 | -1.90 Percent change |
| Ertugliflozin 5 mg | Percent Change From Baseline in Body Weight at Week 12 | -2.50 Percent change |
| Ertugliflozin 10 mg | Percent Change From Baseline in Body Weight at Week 12 | -2.90 Percent change |
| Ertugliflozin 25 mg | Percent Change From Baseline in Body Weight at Week 12 | -2.66 Percent change |
| Sitagliptin 100 mg | Percent Change From Baseline in Body Weight at Week 12 | -0.30 Percent change |
p-value: 0.00780% CI: [-1.75, -0.55]ANCOVA
p-value: 080% CI: [-2.35, -1.14]ANCOVA
p-value: 080% CI: [-2.76, -1.54]ANCOVA
p-value: 080% CI: [-2.52, -1.3]ANCOVA
p-value: 0.83380% CI: [-0.15, 1.06]ANCOVA
Secondary
Percent Change From Baseline in Body Weight at Week 2
The percent change from baseline is the (\[Week 2 body weight minus the Week 0 body weight\] divided by the Week 0 body weight) X 100 (LOCF).
Time frame: Baseline and Week 2
Population: Analysis population included randomized participants who were treated, had a baseline body weight measurement and at least 1 post-baseline body weight measurement up to Week 2.
| Arm | Measure | Value (LEAST_SQUARES_MEAN) |
|---|---|---|
| Placebo | Percent Change From Baseline in Body Weight at Week 2 | -0.24 Percent change |
| Ertugliflozin 1 mg | Percent Change From Baseline in Body Weight at Week 2 | -0.65 Percent change |
| Ertugliflozin 5 mg | Percent Change From Baseline in Body Weight at Week 2 | -1.36 Percent change |
| Ertugliflozin 10 mg | Percent Change From Baseline in Body Weight at Week 2 | -1.14 Percent change |
| Ertugliflozin 25 mg | Percent Change From Baseline in Body Weight at Week 2 | -1.11 Percent change |
| Sitagliptin 100 mg | Percent Change From Baseline in Body Weight at Week 2 | 0.21 Percent change |
p-value: 0.04380% CI: [-0.73, -0.11]ANCOVA
p-value: 080% CI: [-1.44, -0.81]ANCOVA
p-value: 080% CI: [-1.22, -0.59]ANCOVA
p-value: 080% CI: [-1.18, -0.55]ANCOVA
p-value: 0.96780% CI: [0.14, 0.76]ANCOVA
Secondary
Percent Change From Baseline in Body Weight at Week 4
The percent change from baseline is the (\[Week 4 body weight minus the Week 0 body weight\] divided by the Week 0 body weight) X 100 (LOCF).
Time frame: Baseline and Week 4
Population: Analysis population included randomized participants who were treated, had a baseline body weight measurement and at least 1 post-baseline body weight measurement up to Week 4.
| Arm | Measure | Value (LEAST_SQUARES_MEAN) |
|---|---|---|
| Placebo | Percent Change From Baseline in Body Weight at Week 4 | -0.44 Percent change |
| Ertugliflozin 1 mg | Percent Change From Baseline in Body Weight at Week 4 | -1.20 Percent change |
| Ertugliflozin 5 mg | Percent Change From Baseline in Body Weight at Week 4 | -1.76 Percent change |
| Ertugliflozin 10 mg | Percent Change From Baseline in Body Weight at Week 4 | -1.68 Percent change |
| Ertugliflozin 25 mg | Percent Change From Baseline in Body Weight at Week 4 | -1.52 Percent change |
| Sitagliptin 100 mg | Percent Change From Baseline in Body Weight at Week 4 | 0.01 Percent change |
p-value: 0.00880% CI: [-1.17, -0.36]ANCOVA
p-value: 080% CI: [-1.73, -0.91]ANCOVA
p-value: 080% CI: [-1.65, -0.83]ANCOVA
p-value: 080% CI: [-1.49, -0.67]ANCOVA
p-value: 0.92280% CI: [0.04, 0.86]ANCOVA
Secondary
Percent Change From Baseline in Body Weight at Week 8
The percent change from baseline is the (\[Week 8 body weight minus the Week 0 body weight\] divided by the Week 0 body weight) X 100 (LOCF).
Time frame: Baseline and Week 8
Population: Analysis population included randomized participants who were treated, had a baseline body weight measurement and at least 1 post-baseline body weight measurement up to Week 8.
| Arm | Measure | Value (LEAST_SQUARES_MEAN) |
|---|---|---|
| Placebo | Percent Change From Baseline in Body Weight at Week 8 | -0.62 Percent change |
| Ertugliflozin 1 mg | Percent Change From Baseline in Body Weight at Week 8 | -1.65 Percent change |
| Ertugliflozin 5 mg | Percent Change From Baseline in Body Weight at Week 8 | -2.18 Percent change |
| Ertugliflozin 10 mg | Percent Change From Baseline in Body Weight at Week 8 | -2.30 Percent change |
| Ertugliflozin 25 mg | Percent Change From Baseline in Body Weight at Week 8 | -2.40 Percent change |
| Sitagliptin 100 mg | Percent Change From Baseline in Body Weight at Week 8 | -0.38 Percent change |
p-value: 0.00380% CI: [-1.51, -0.56]ANCOVA
p-value: 080% CI: [-2.04, -1.09]ANCOVA
p-value: 080% CI: [-2.16, -1.21]ANCOVA
p-value: 080% CI: [-2.26, -1.3]ANCOVA
p-value: 0.74180% CI: [-0.24, 0.71]ANCOVA