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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Enrollment
375
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
Baseline Hemoglobin A1c (HbA1c)
HbA1c is measured as percent.
Time frame: Baseline
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
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
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
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
Baseline Body Weight
Time frame: Baseline
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
Percent Change From Baseline in Body Weight at Week 2
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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
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).
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
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
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
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
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
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
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
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
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
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
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
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
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
Baseline Fasting Plasma Glucose
Laboratory measurements were performed after an overnight fast ≥8 hours in duration.
Time frame: Baseline
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
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
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
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
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
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
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
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