CI

At a glance

ClinicalIndex Comparison Record
Phase 3Completed· 171 enrolled
Drug / intervention
LMF237 50/250 mg +2 moredrug
Likely dose
LMF237 50/250 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/NCT01811485
NCT01811485Phase 3Completed
CompareCT.gov

A Multicenter, Double-Blind, Randomized, Parallel-Group Study to Compare the Effect of 14 Weeks Treatment With LMF237 Bid to Placebo in Patients With Type 2 Diabetes Inadequately Controlled With Vildagliptin 50 mg Bid Monotherapy

Novartis Pharmaceuticals·interventional·Posted Mar 14, 2013·Updated Feb 23, 2015

In Brief

A Phase 3 clinical trial evaluating LMF237 50/250 mg, LMF237 50/500 mg, and 1 other intervention for Diabetes Mellitus, Type 2. Completed, enrolled 171 participants across 30 sites.

Detailed Summary

The purpose of the study was to evaluate the efficacy and safety of LMF237 50/250 mg and 50/500 mg bid in Japanese patients with T2DM inadequately controlled with vildagliptin monotherapy. This study was conducted to support registration of the fixed-dose combination of vildagliptin and metformin for the treatment of T2DM in Japan.

Study Details

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

Timeline

Phase 3CompletedFinished
20132014201520162017201820192020202120222023202420252026
First PostedMar 14, 2013
Enrollment StartMay 1, 2013
Primary CompletionFeb 1, 2014
TodayJul 2, 2026
Enrollment to primary: 9 monthsPosted 13.3 years ago

Interventions

LMF237 50/250 mgdrug

Corresponds to vildagliptin 50 mg twice daily and metformin 250 mg twice daily

LMF237 50/500 mgdrug

Corresponds to vildagliptin 50 mg twice daily and metformin 500 mg twice daily

Placebodrug

Matching placebo of LMF237 (contained vildagliptin 50 mg as active ingredient) twice daily