CI

At a glance

ClinicalIndex Comparison Record
Phase 2Completed· 983 enrolled
Drug / intervention
Placebo +19 moredrug
Likely dose
Not stated in 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/NCT01649297
NCT01649297Phase 2Completed
CompareCT.gov

A Randomised, Double Blind, Placebo Controlled, Parallel Group Efficacy and Safety Study of Oral Administration of Empagliflozin Twice Daily Versus Once Daily in Two Different Daily Doses Over 16 Weeks as add-on Therapy to a Twice Daily Dosing Regimen of Metformin in Patients With Type 2 Diabetes Mellitus and Insufficient Glycaemic Control

Boehringer Ingelheim·interventional·Posted Jul 25, 2012·Updated Jul 23, 2015

In Brief

A Phase 2 clinical trial evaluating Placebo, empagliflozin (low dose qd), and 3 other interventions for Diabetes Mellitus, Type 2. Completed, enrolled 983 participants across 139 sites in 18 countries.

Detailed Summary

The aim of this study is to investigate the efficacy and safety of two doses (high and low) of empagliflozin as add-on therapy to metformin in patients with type 2 diabetes mellitus (T2DM) and insufficient glycaemic control. Both doses may be given once daily or split to a twice daily dosage. This results in 4 different dosage regimens of empagliflozin (high dose once daily or split vs. low dose once daily or split). This is done to evaluate whether a twice daily dose regimen of empagliflozin results in a loss of efficacy relative to once daily dosing when given on top of metformin background therapy.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsDiabetes Mellitus, Type 2
CountriesAustralia, Canada, Estonia, France, Georgia, Germany, Guatemala, Italy, Latvia, Lithuania, Mexico, New Zealand, Poland, Russia, South Africa, Spain, Ukraine, United States
CollaboratorsEli Lilly and Company

Timeline

Phase 2CompletedFinished
20132014201520162017201820192020202120222023202420252026
First PostedJul 25, 2012
Enrollment StartOct 1, 2012
Primary CompletionDec 1, 2013
TodayJul 2, 2026
Enrollment to primary: 1.2 yearsPosted 13.9 years ago

Interventions

Placebodrug

Patients receive placebo matching empagliflozin (low dose qd)

Placebodrug

Patients receive placebo matching empagliflozin (low dose bid)

Placebodrug

Patients receive placebo matching Empagliflozin (high dose qd)

Placebodrug

Patients receive placebo matching Empagliflozin (high dose qd)

Placebodrug

Patients receive placebo matching Empagliflozin (high dose qd)

empagliflozin (low dose qd)drug

Patients receive Empagliflozin low dose once daily

Placebodrug

Patients receive placebo matching empagliflozin (low dose qd)

Placebodrug

Patients receive placebo matching empagliflozin (low dose bid)

Placebodrug

Patients receive placebo matching Empagliflozin (high dose bid)

Placebodrug

Patients receive placebo matching Empagliflozin (high dose bid)

Placebodrug

Patients receive placebo matching empagliflozin (low dose qd)

Placebodrug

Patients receive placebo matching empagliflozin (low dose bid)

Placebodrug

Patients receive placebo matching Empagliflozin (high dose bid)

Placebodrug

Patients receive placebo matching empagliflozin (low dose qd)

Placebodrug

Patients receive placebo matching empagliflozin (low dose bid)

Placebodrug

Patients receive placebo matching Empagliflozin (high dose bid)

Empagliflozin (high dose qd)drug

Patients receive Empagliflozin high dose once daily

empagliflozin (high dose bid)drug

Patients receive Empagliflozin high dose split twice daily

Placebodrug

Patients receive placebo matching Empagliflozin (high dose qd)

empagliflozin (low dose bid)drug

Patients receive Empagliflozin low dose split twice daily