CI

At a glance

ClinicalIndex Comparison Record
Phase 3Completed· 353 enrolled
Drug / intervention
Comparator: Sitagliptin +3 moredrug
Likely dose
Sitagliptin 100 mg once dailyAI-extracted
Key inclusion· 3
  • ✓Type 2 diabetes mellitus
  • ✓Age 18 years or older
  • ✓Not pregnant or breast-feeding
Key exclusion· 15
  • ✕History of type 1 diabetes or ketoacidosis
  • ✕Insulin use within prior 8 weeks
  • ✕Acute coronary syndrome, coronary artery intervention, or stroke within past 6 months
  • ✕New or worsening coronary heart disease signs/symptoms within past 3 months

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

Search/NCT00086502
NCT00086502Phase 3Completed
CompareCT.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 Pioglitazone Therapy

Merck Sharp & Dohme LLC·interventional·Posted Jul 5, 2004·Updated Feb 5, 2016

In Brief

A Phase 3 clinical trial evaluating Comparator: Sitagliptin, Comparator: Placebo, and 2 other interventions for Diabetes Mellitus, Type 2. Completed, enrolled 353 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 2
Countries--
Collaborators--

Timeline

Phase 3CompletedFinished
200420052006200720082009201020112012201320142015201620172018201920202021202220232024202520262027
First PostedJul 5, 2004
Enrollment StartJun 1, 2004
Primary CompletionNov 1, 2005
TodayJul 2, 2026
Enrollment to primary: 1.4 yearsPosted 22.0 years ago

Interventions

Comparator: Sitagliptindrug

Sitagliptin 100 mg once daily, from Visit 4 through Visit 8. Day 1 through week 24

Comparator: Placebodrug

Placebo (to match Sitagliptin 100 mg) once daily, from Visit 4 through Visit 8. Day 1 through Week 24

Comparator: Pioglitazonedrug

Pioglitazone 30 mg or 45 mg once daily, Visit 2 through Visit 8

Metformindrug

Metformin rescue for patients meeting pre-specified glycemic criteria. Metformin 500 mg,once daily, Visit 4 through Visit 8