CI

At a glance

ClinicalIndex Comparison Record
Phase 3Completed· 219 enrolled
Drug / intervention
Empagliflozin +1 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/NCT04233801
NCT04233801Phase 3Completed

A Phase III, Randomised, Double-blind, Placebo-controlled, Parallel Group Study of Empagliflozin (10 mg and 25 mg) Administered Orally Once Daily in Combination With Insulin With or Without up to Two Oral Anti-diabetic Agents for 24 Weeks in Chinese Type 2 Diabetic Patients With Insufficient Glycemic Control.

Boehringer Ingelheim·interventional·Posted Jan 18, 2020·Updated Dec 15, 2023

In Brief

A Phase 3 clinical trial evaluating Empagliflozin and Placebo for Diabetes Mellitus, Type 2. Completed, enrolled 219 participants across 24 sites.

Detailed Summary

This is a study in Chinese adults with type 2 diabetes. The study is open to people who take insulin but still have too high blood sugar levels. Participants may additionally be taking up to 2 other medicines for their diabetes. The purpose of this study is to find out whether empagliflozin taken together with insulin helps people with type 2 diabetes to better control their blood sugar. The participants are in the study for about 7 months. During this time, they visit the study site about 8 times, 1 additional visit may be either a visit to the study site or a phone call. At the start of the study, participants are put into 3 groups by chance. Participants get either 10 mg empagliflozin tablets, or 25 mg empagliflozin tablets, or placebo tablets once a day. Placebo tablets look like empagliflozin tablets but do not contain any medicine. The doctors regularly take blood samples from the participants. The changes in blood sugar levels are compared between the groups. The doctors also check the general health of the participants.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
CountriesChina
Collaborators--

Timeline

Phase 3CompletedFinished
2020202120222023202420252026
First PostedJan 18, 2020
Enrollment StartApr 15, 2020
Primary CompletionMar 3, 2022
Study CompletionMar 10, 2022
TodayJul 2, 2026
Enrollment to primary: 1.9 yearsPosted 6.5 years ago

Interventions

Empagliflozindrug

Empagliflozin

Placebodrug

Placebo