CI

At a glance

ClinicalIndex Comparison Record
Phase 3Completed· 190 enrolled
Drug / intervention
sitagliptin 100 mg q.d./metformin ≥ 1500 mg/day +1 moredrug
Likely dose
sitagliptin 100 mg q.d./metformin ≥ 1500 mg/dayfrom 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/NCT00337610
NCT00337610Phase 3Completed
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A Multicenter, Double-Blind, Randomized Study to Evaluate the Safety and Efficacy of the Addition of Sitagliptin to Patients With Type 2 Diabetes Mellitus Who Have Inadequate Glycemic Control on Metformin Therapy

Merck Sharp & Dohme LLC·interventional·Posted Jun 16, 2006·Updated May 12, 2016

In Brief

A Phase 3 clinical trial evaluating sitagliptin 100 mg q.d./metformin ≥ 1500 mg/day and comparator: placebo to match sitagliptin 100 mg q.d./metformin ≥ 1500 mg/day for Type 2 Diabetes Mellitus (T2DM). Completed, enrolled 190 participants.

Detailed Summary

A clinical study to determine the safety and efficacy of sitagliptin in patients with Type 2 Diabetes Mellitus who have inadequate glycemic (blood sugar) control on metformin therapy.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsType 2 Diabetes Mellitus (T2DM)
Countries--
Collaborators--

Timeline

Phase 3CompletedFinished
2006200720082009201020112012201320142015201620172018201920202021202220232024202520262027
First PostedJun 16, 2006
Enrollment StartJun 1, 2006
Primary CompletionMay 1, 2007
Study CompletionAug 1, 2007
TodayJul 2, 2026
Enrollment to primary: 11 monthsPosted 20.0 years ago

Interventions

sitagliptin 100 mg q.d./metformin ≥ 1500 mg/daydrug

Patients will receive blinded sitagliptin 100 mg q.d. and open-label metformin ≥ 1500 mg/day for up to 30 weeks. Sitagliptin 100 mg q.d. and metformin ≥ 1500 mg/day will be administered as oral tablets.

comparator: placebo to match sitagliptin 100 mg q.d./metformin ≥ 1500 mg/daydrug

Patients will receive placebo to match sitagliptin 100 mg q.d. and open-label metformin ≥ 1500 mg/day for up to 30 weeks. Sitagliptin 100 mg q.d. and metformin ≥ 1500 mg/day will be administered as oral tablets.