drugset / Trial / NCT02226003

Efficacy and Safety of Ertugliflozin (MK-8835/PF-04971729) With Sitagliptin in the Treatment of Participants With Type 2 Diabetes Mellitus (T2DM) With Inadequate Glycemic Control on Diet and Exercise (MK-8835-017)

NCT02226003

Phase 3 Completed 291 enrolled Merck Sharp & Dohme LLC Pfizer · collab
RandomizedParallel-groupDouble-blindTreatment

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.

Timeline

Start
2014-09-23
Primary completion
2016-02-23
Completion
2016-02-23

Publications

Drugs

EvaluationDrugModalityDoseRoute
Subject Ertugliflozin Unknown 5 mg Oral
Subject Ertugliflozin Unknown 15 mg Oral
Subject Sitagliptin Small molecule 100 mg Oral
Background Glimepiride Small molecule 1 mg Oral
Background Glimepiride Small molecule 2 mg Oral