Study on the Efficacy and Safety of Chiglitazar Sodium in PCOS With T2DM
Summary
Purpose and significance: To explore the clinical efficacy and safety of Chiglitazar sodium in polycystic ovary syndrome with type 2 diabetes Methods: From October 2022 to September 2024, a total of 142 PCOS with T2DM patients admitted to Department of Endocrinology and Metabolism at the Affiliated Hospital of Nantong University were recruited. Participants are randomized in a ratio of 1:1 into two treatment groups of 71 participants: ① control group；②experimental group. After randomization, the control group was treated with lifestyle intervention+ metformin+ orlistat (obese patients)+ pioglitazone, and the patients in the experimental group were treated with lifestyle intervention+ metformin+ orlistat (obese patients)+ Chiglitazar (32mg QD) until the end of follow-up. The treatment and follow-up period totaled 3 months. Observe the body weight, menstrual cycle and blood glucose control and other related indicators. Type of study: randomized controlled, prospective, intervention study.
Timeline
- Start
- 2022-10-01
- Primary completion
- 2023-09-30
- Completion
- 2024-09-30
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | Chiglitazar | Unknown | 32 mg | — |
| Subject | Pioglitazone | Small molecule | 15 mg | Oral |
| Background | Metformin | Small molecule | 0.5 g | Oral |
| Background | Orlistat | Small molecule | 0.12 g | Oral |