At a glance
ClinicalIndex Comparison RecordStandardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.
A Phase III, Randomized, Double-Blind, Placebo-Controlled, Parallel-Group, Multicenter Clinical Trial to Evaluate the Efficacy and Safety of the Initial Combination of Ertugliflozin (MK-8835/PF-04971729) With Sitagliptin in the Treatment of Subjects With T2DM With Inadequate Glycemic Control on Diet and Exercise
In Brief
A Phase 3 clinical trial evaluating Ertugliflozin, Sitagliptin, and 3 other interventions for Type 2 Diabetes Mellitus. Completed, enrolled 291 participants.
Detailed 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.
Study Details
Timeline
Interventions
Ertugliflozin, 5 mg or 15 mg, administered orally, once daily for 26 weeks.
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.
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.