CI

At a glance

ClinicalIndex Comparison Record
Phase 3Completed· 1,413 enrolled
Drug / intervention
Metformin 500 mg bid +13 moredrug
Likely dose
Metformin 500 mg bidfrom 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/NCT01719003
NCT01719003Phase 3Completed
CompareCT.gov

A 24-week Phase III Randomized, Double-blind, Parallel Group Study to Evaluate the Efficacy and Safety of Twice Daily Oral Administration of Empagliflozin + Metformin Compared With the Individual Components of Empagliflozin or Metformin in Drug Naive Patients With Type 2 Diabetes Mellitus

Boehringer Ingelheim·interventional·Posted Nov 1, 2012·Updated Feb 19, 2016

In Brief

A Phase 3 clinical trial evaluating Metformin 500 mg bid, Metformin 1000 mg bid, and 4 other interventions for Diabetes Mellitus, Type 2 and Hyperglycemia. Completed, enrolled 1,413 participants across 190 sites in 21 countries.

Detailed Summary

This study will investigate the efficacy and safety of two doses (high and low) of empagliflozin in combination with metformin (500 mg and 1000 mg) administered twice daily in patients with type 2 diabetes mellitus (T2DM). Study will compare four dose combinations of empagliflozin + metformin versus each individual component after 24 weeks of treatment.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsDiabetes Mellitus, Type 2, Hyperglycemia
CountriesBrazil, Canada, Czechia, Egypt, France, Germany, Guatemala, Lebanon, Malaysia, Mexico, Peru, Philippines, Russia, Serbia, South Korea, Spain, Taiwan, Thailand, Turkey (Türkiye), United Kingdom, United States
CollaboratorsEli Lilly and Company

Timeline

Phase 3CompletedFinished
20132014201520162017201820192020202120222023202420252026
First PostedNov 1, 2012
Enrollment StartOct 1, 2012
Primary CompletionNov 1, 2014
Study CompletionDec 1, 2014
TodayJul 2, 2026
Enrollment to primary: 2.1 yearsPosted 13.7 years ago

Interventions

Metformin 500 mg biddrug

Metformin 500 mg twice daily

Metformin 1000 mg biddrug

Metformin 1000 mg twice daily

Empagliflozin low dose qddrug

Empagliflozin low dose once daily

Empagliflozin high dose qddrug

Empagliflozin high dose once daily

Empagliflozin low dose biddrug

Empagliflozin low dose split twice daily

Metformin 500 mg biddrug

Metformin 500 mg twice daily

Empagliflozin high dose biddrug

Empagliflozin high dose split twice daily

Empagliflozin low dose biddrug

Empagliflozin low dose split twice daily

Metformin 1000 mg biddrug

Metformin 1000 mg twice daily

Metformin 500 mg biddrug

Metformin 500 mg twice daily

Metformin 1000 mg biddrug

Metformin 1000 mg twice daily

Empagliflozin high dose biddrug

Empagliflozin high dose split twice daily

Metformin 1000 mg biddrug

Metformin 1000 mg twice daily

Empagliflozin high dose biddrug

Empagliflozin high dose split twice daily