At a glance

ClinicalIndex Comparison Record

Phase 3Completed· 701 enrolled

Drug / intervention

Sitagliptin (MK0431) +3 moredrug

Likely dose

Sitagliptin 100 mg orally once dailyAI-extracted

Key inclusion· 1

✓Diagnosis of type 2 diabetes mellitus

Key exclusion· 0

None specified.

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

Search/NCT00086515

NCT00086515Phase 3Completed

Compare CT.gov

A Multicenter, Randomized, Double-Blind Study to Evaluate the Safety and Efficacy of the Addition of MK0431 to Patients With Type 2 Diabetes Mellitus Who Have Inadequate Glycemic Control on Metformin Therapy

Merck Sharp & Dohme LLC·interventional·Posted Jul 5, 2004·Updated May 5, 2017

In Brief

A Phase 3 clinical trial evaluating Sitagliptin (MK0431), Placebo/Glipizide 5 mg, and 2 other interventions for Diabetes Mellitus, Type II. Completed, enrolled 701 participants.

Detailed Summary

The purpose of this study is to determine the safety and efficacy of an investigational drug in patients with type 2 diabetes mellitus.

Study Details

Study Typeinterventional

Allocation--

Masking--

Primary Purpose--

ConditionsDiabetes Mellitus, Type II

Countries--

Collaborators--

Timeline

Phase 3CompletedFinished

200420052006200720082009201020112012201320142015201620172018201920202021202220232024202520262027

Enrollment StartJun 2004

First PostedJul 2004

Primary CompletionJul 2005

Study CompletionFeb 2007

TodayJul 2026

First PostedJul 5, 2004

Enrollment StartJun 30, 2004

Primary CompletionJul 20, 2005

Study CompletionFeb 2, 2007

TodayJul 2, 2026

Enrollment to primary: 1.1 yearsPosted 22.0 years ago

Interventions

Sitagliptin (MK0431)drug

Sitagliptin 100 mg once daily, from Visit 4 through Final Visit, week 104

Placebo/Glipizide 5 mgdrug

Placebo (to match Sitagliptin 100 mg) from Visit 4 through Visit 8; Glipizide 5 mg from Visit 8, week 24 to Final Visit (Week 104)

Metformindrug

Metformin 1500 mg, once daily, from Visit 2 to Final Visit (Week 104)

Pioglitazonedrug

Pioglitazone 15 mg once daily, for patients not meeting specific glycemic goals during the placebo-controlled treatment period \[Phase A\], from Visit 5 (Week 6) to Visit 8 (Week 24)