CI

At a glance

ClinicalIndex Comparison Record
Phase 3Completed· 521 enrolled
Drug / intervention
Comparator: sitagliptin 100 mg +3 moredrug
Likely dose
Sitagliptin 100–200 mg orally once daily for 54 weeksAI-extracted
Key inclusion· 2
  • ✓Age 18–75 years
  • ✓Type 2 Diabetes Mellitus diagnosis
Key exclusion· 2
  • ✕Age <18 or >75 years
  • ✕Any condition deemed not in patient's best interest by investigator

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

Search/NCT00094757
NCT00094757Phase 3Completed
CompareCT.gov

A Multicenter, Randomized, Double-Blind Study of MK0431 in Patients With Type 2 Diabetes Mellitus Who Have Inadequate Glycemic Control

Merck Sharp & Dohme LLC·interventional·Posted Oct 25, 2004·Updated May 30, 2019

In Brief

A Phase 3 clinical trial evaluating Comparator: sitagliptin 100 mg, Comparator: sitagliptin 200 mg, and 2 other interventions for Diabetes Mellitus, Type 2. Completed, enrolled 521 participants.

Detailed Summary

The purpose of this study is to determine the safety and effectiveness 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
20052006200720082009201020112012201320142015201620172018201920202021202220232024202520262027
First PostedOct 25, 2004
Enrollment StartOct 6, 2004
Primary CompletionAug 17, 2005
Study CompletionApr 28, 2006
TodayJul 2, 2026
Enrollment to primary: 10 monthsPosted 21.7 years ago

Interventions

Comparator: sitagliptin 100 mgdrug

sitagliptin 100 mg oral tablet once daily for 54 weeks

Comparator: sitagliptin 200 mgdrug

sitagliptin 200 mg (2- 100 mg oral tablets) once daily for 54 weeks

Comparator: placebodrug

placebo oral tablet once daily during Phase A (Weeks 0-18)

Comparator: pioglitazonedrug

pioglitazone 30 mg oral tablet once daily during Phase B (Weeks 18-54)