Trials / Unknown
UnknownNCT05054842
Clinical Study of Retagliptin Phosphate Combined With Metformin in the Treatment of Type 2 Diabetes
Efficacy and Safety of Retagliptin Phosphate in Combination With Metformin in Type 2 Diabetic Subjects With Poor Metformin Glycemic Control: a Phase III Multicenter, Randomized, Double-blind, Placebo-controlled Design
- Status
- Unknown
- Phase
- Phase 3
- Study type
- Interventional
- Enrollment
- 174 (actual)
- Sponsor
- Jiangsu HengRui Medicine Co., Ltd. · Industry
- Sex
- All
- Age
- 18 Years – 75 Years
- Healthy volunteers
- Not accepted
Summary
Retagliptin phosphate tablet is a DPP IV inhibitor durg，study number is HR-SP2086-304. The primary purpose of the study is to evaluate the efficacy of the combination of Retagliptin phosphate and metformin compared with placebo and metformin in type 2 diabetes subjects with poor glycemic control treated with metformin for 16 weeks.
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| DRUG | Retagliptin phosphate tablets、metformin sustained-release tablets | Retagliptin phosphate tablets 100mg+ metformin sustained-release tablets 1500mg or 2000mg based on prior medication |
| DRUG | Retagliptin phosphate placebo tablets、metformin sustained-release tablets | Retagliptin phosphate 100mg placebo tablets + metformin sustained-release tablets 1500mg or 2000mg based on prior medication |
Timeline
- Start date
- 2021-12-06
- Primary completion
- 2023-12-01
- Completion
- 2023-12-01
- First posted
- 2021-09-23
- Last updated
- 2023-07-10
Locations
1 site across 1 country: China
Source: ClinicalTrials.gov record NCT05054842. Inclusion in this directory is not an endorsement.