CI

At a glance

ClinicalIndex Comparison Record
Phase 3Completed· 1,233 enrolled
Drug / intervention
Matching Placebo to Ertugliflozin 5 mg +8 moredrug
Likely dose
Matching Placebo to Ertugliflozin 5 mgfrom record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT02099110
NCT02099110Phase 3Completed
CompareCT.gov

A Phase III, Randomized, Double-Blind, Multicenter Study to Evaluate the Efficacy and Safety of the Combination of Ertugliflozin (MK-8835/PF-04971729) With Sitagliptin Compared With Ertugliflozin Alone and Sitagliptin Alone, in the Treatment of Subjects With T2DM With Inadequate Glycemic Control on Metformin Monotherapy

Merck Sharp & Dohme LLC·interventional·Posted Mar 28, 2014·Updated Sep 12, 2018

In Brief

A Phase 3 clinical trial evaluating Matching Placebo to Ertugliflozin 5 mg, Matching Placebo to Ertugliflozin 10 mg, and 7 other interventions for Type 2 Diabetes Mellitus. Completed, enrolled 1,233 participants.

Detailed Summary

This is a study of co-administration of ertugliflozin (MK-8835/PF-04971729) and sitagliptin given together or alone along with metformin in participants with Type 2 diabetes mellitus (T2DM) and inadequate glycemic control on metformin monotherapy. The primary hypothesis of this study is that ertugliflozin 15 mg daily plus sitagliptin 100 mg daily provides greater hemoglobin A1C (A1C)-lowering compared with sitagliptin 100 mg daily alone.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsType 2 Diabetes Mellitus
Countries--
CollaboratorsPfizer

Timeline

Phase 3CompletedFinished
2014201520162017201820192020202120222023202420252026
First PostedMar 28, 2014
Enrollment StartApr 22, 2014
Primary CompletionMay 26, 2016
TodayJul 2, 2026
Enrollment to primary: 2.1 yearsPosted 12.3 years ago

Interventions

Matching Placebo to Ertugliflozin 5 mgdrug

Placebo to ertugliflozin 5 mg tablet, oral, once daily for 52 weeks during the double-blind treatment period

Matching Placebo to Ertugliflozin 10 mgdrug

Placebo to ertugliflozin 10 mg tablet, oral, once daily for 52 weeks during the double-blind treatment period

Matching Placebo to sitagliptin 100 mgdrug

Placebo to sitagliptin 100 mg tablet, oral, once daily for 52 weeks during the double-blind treatment period

Ertugliflozin 5 mgdrug

Ertugliflozin 5 mg tablet, oral, once daily for 52 weeks during the double-blind treatment period

Ertugliflozin 10 mgdrug

Ertugliflozin 10 mg tablet, oral, once daily for 52 weeks during the double-blind treatment period

Sitagliptin 100 mgdrug

Sitagliptin 100 mg tablet, oral, once daily for 52 weeks during the double-blind treatment period

Metformin >= 1500 mg/daydrug

Metformin \>= 1500 mg/day, tablets, oral, for 52 weeks while receiving blinded investigational product during the double-blind treatment period

Insulin Glargine Rescue Medicationbiological

Open-label insulin glargine, subcutaneous injection, as required as a rescue medication; dose determined per the investigator's discretion

Glimepiride Rescue Medicationdrug

Open-label glimepiride tablets, oral, as required as a rescue medication, dose determined per the investigator's discretion