CI

At a glance

ClinicalIndex Comparison Record
Phase 4Completed· 532 enrolled
Drug / intervention
Metformin IR +1 moredrug
Likely dose
Metformin IR 500 milligramfrom 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/NCT02252965
NCT02252965Phase 4Completed
CompareCT.gov

CONSENT - Comparison of metfOrmin XR to IR as moNotherapy in the Newly diagnoSed Type 2 diabEtes Patients for the gastroiNtestinal Tolerability and Efficacy: a Randomized, Parallel Control, Open-label and Multicenter Study

Merck KGaA, Darmstadt, Germany·interventional·Posted Sep 30, 2014·Updated Jan 24, 2017

In Brief

A Phase 4 clinical trial evaluating Metformin IR and Metformin XR for Diabetes Mellitus, Type 2. Completed, enrolled 532 participants across 1 site.

Detailed Summary

This is a Phase 4, prospective, open label, randomized, parallel controlled multicenter trial in which metformin extended release (XR) will be compared with metformin immediate release (IR) for the gastrointestinal tolerability and efficacy in the newly diagnosed subjects with Type 2 diabetes who have glycosylated hemoglobin (HbA1c) value between 7.0 to 10.0 percent (%).

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsDiabetes Mellitus, Type 2
CountriesGermany
Collaborators--

Timeline

Phase 4CompletedFinished
201520162017201820192020202120222023202420252026
First PostedSep 30, 2014
Enrollment StartDec 1, 2014
Primary CompletionNov 1, 2015
Study CompletionApr 1, 2016
TodayJul 2, 2026
Enrollment to primary: 11 monthsPosted 11.8 years ago

Interventions

Metformin IRdrug

Subjects will receive Metformin Immediate Release (IR) tablets, orally once daily at a dose of 500 milligram (mg) for 1 week, and then dose will increase with increments of 500 mg every week in first 2 weeks to 1500 mg. After that dose will increase up to maximum dose of 2000 mg for the next 2 weeks and will be maintained at 2000 mg until Week 16.

Metformin XRdrug

Subjects will receive Metformin Extended Release (XR) tablets, orally once daily at a dose of 500 mg for 1 week, and then dose will increase with increments of 500 mg every week in first 2 weeks to 1500 mg. After that dose will increase up to maximum dose of 2000 mg for the next 2 weeks and will be maintained at 2000 mg until Week 16.