CI

At a glance

ClinicalIndex Comparison Record
Phase 3Completed· 1,512 enrolled
Drug / intervention
sitagliptin phosphate +2 moredrug
Likely dose
sitagliptin phosphate 100 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/NCT00545584
NCT00545584Phase 3Completed
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Multicenter, Open, Pragmatic, Randomized Trial Comparing the Efficacy of 3 Different Lifestyle Interventions After Addition of Sitagliptin to Patients With Type 2 Diabetes Mellitus Who Have Inadequate Glycemic Control on Metformin Therapy

Merck Sharp & Dohme LLC·interventional·Posted Oct 17, 2007·Updated May 12, 2017

In Brief

A Phase 3 clinical trial evaluating sitagliptin phosphate, Comparator: Diet, and 1 other intervention for Diabetes Mellitus, Non-Insulin-Dependent. Completed, enrolled 1,512 participants.

Detailed Summary

To compare the efficacy of three strategies of lifestyle changes associated with Januvia (sitagliptin) 100 mg/day in patients with Type 2 Diabetes Mellitus (T2DM) inadequately controlled by metformin (hemoglobin A1c \[HbA1c\] 6.5-9%). A difference between the three strategies of lifestyle changes was expected.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsDiabetes Mellitus, Non-Insulin-Dependent
Countries--
Collaborators--

Timeline

Phase 3CompletedFinished
200720082009201020112012201320142015201620172018201920202021202220232024202520262027
First PostedOct 17, 2007
Enrollment StartApr 1, 2007
Primary CompletionNov 19, 2009
TodayJul 2, 2026
Enrollment to primary: 2.6 yearsPosted 18.7 years ago

Interventions

sitagliptin phosphatedrug

sitagliptin 100 mg once daily. Duration of treatment: 26 Weeks

Comparator: Dietbehavioral

Diet

Comparator: Physical Activitybehavioral

Physical Activity