Trials / Completed
CompletedNCT04807348
Chiglitazar Added to Metformin for Type 2 Diabetes
A Randomised Double-blind Placebo Parallel Controlled Phase Ⅲ Clinical Study to Evaluate the Efficacy and Safety of Chiglitazar Added to Metformin in Patients With Type 2 Diabetes Inadequately Controlled With Metformin Monotherapy (RECAM)
- Status
- Completed
- Phase
- Phase 3
- Study type
- Interventional
- Enrollment
- 533 (actual)
- Sponsor
- Chipscreen Biosciences, Ltd. · Industry
- Sex
- All
- Age
- 18 Years – 75 Years
- Healthy volunteers
- Not accepted
Summary
The purpose of the trial is to evaluate the effect of Chiglitazar added to metformin to type 2 diabetes Inadequately controlled with metformin Monotherapy.
Detailed description
This clinical trial is a multi-center, randomized, double-blind, placebo parallel control design, and uses superiority test to determine whether the experimental group is superior to the control group in terms of main efficacy endpoints.
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| DRUG | Chiglitazar 32mg | Administrated once daily |
| DRUG | Chiglitazar 48mg | Administrated once daily |
| DRUG | Placebo | Placebo of Chiglitazar |
| DRUG | Metformin Hydrochloride | most tolerable dose |
Timeline
- Start date
- 2021-07-06
- Primary completion
- 2023-02-10
- Completion
- 2023-02-10
- First posted
- 2021-03-19
- Last updated
- 2024-07-15
Locations
50 sites across 1 country: China
Source: ClinicalTrials.gov record NCT04807348. Inclusion in this directory is not an endorsement.