Trials / Completed
CompletedNCT04233801
A Study to Test How Well Empagliflozin Works in Chinese Patients With Type 2 Diabetes Who Already Take Insulin
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.
- Status
- Completed
- Phase
- Phase 3
- Study type
- Interventional
- Enrollment
- 219 (actual)
- Sponsor
- Boehringer Ingelheim · Industry
- Sex
- All
- Age
- 18 Years – 75 Years
- Healthy volunteers
- Not accepted
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.
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| DRUG | Empagliflozin | Empagliflozin |
| DRUG | Placebo | Placebo |
Timeline
- Start date
- 2020-04-15
- Primary completion
- 2022-03-03
- Completion
- 2022-03-10
- First posted
- 2020-01-18
- Last updated
- 2023-12-15
- Results posted
- 2023-12-15
Locations
24 sites across 1 country: China
Source: ClinicalTrials.gov record NCT04233801. Inclusion in this directory is not an endorsement.