CI

At a glance

ClinicalIndex Comparison Record
Phase 3Completed· 60 enrolled
Drug / intervention
Placebo +5 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/NCT01947855
NCT01947855Phase 3Completed

A Randomised, Double-blind, Placebo-controlled, Parallel Group, 4-week Study to Evaluate the Efficacy of Empagliflozin (10 mg and 25 mg Administered Orally Once Daily) in Postprandial Glucose and 24-hour Glucose Variability in Japanese Patients With Type 2 Diabetes Mellitus With Insufficient Glycaemic Control

Boehringer Ingelheim·interventional·Posted Sep 23, 2013·Updated Dec 24, 2014

In Brief

A Phase 3 clinical trial evaluating Placebo and Empagliflozin for Diabetes Mellitus, Type 2. Completed, enrolled 60 participants across 2 sites.

Detailed Summary

To evaluate the efficacy of empagliflozin administered orally once daily in postprandial glucose and 24-hour glycaemic variability compared to placebo given for 4 weeks as mono-therapy in Japanese patients with type 2 diabetes mellitus with insufficient glycaemic control on no antidiabetic treatment.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
CountriesJapan

Timeline

Phase 3CompletedFinished
2014201520162017201820192020202120222023202420252026
First PostedSep 23, 2013
Enrollment StartSep 1, 2013
Primary CompletionDec 1, 2013
TodayJul 2, 2026
Enrollment to primary: 3 monthsPosted 12.8 years ago

Interventions

Placebodrug

Placebo tablet matching Empagliflozin low dose

Empagliflozindrug

Empagliflozin low dose

Placebodrug

Placebo tablet matching Empagliflozin high dose

Placebodrug

Placebo tablet matching Empagliflozin low dose

Empagliflozindrug

Empagliflozin high dose tablet once daily

Placebodrug

Placebo tablet matching Empagliflozin high dose