NCT05760677

Study on the Efficacy and Safety of Chiglitazar Sodium in PCOS With T2DM

Study on the Efficacy and Safety of Chiglitazar Sodium in the Treatment of Polycystic Ovary Syndrome With Type 2 Diabetes

• Status: Unknown
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 142 (estimated)
• Sponsor: Affiliated Hospital of Nantong University · Academic / Other
• Sex: Female
• Age: 40 Years
• Healthy volunteers: Not accepted

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.

Detailed description

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.

Conditions

• PCOS (Polycystic Ovary Syndrome) of Bilateral Ovaries
• T2D

Interventions

Type	Name	Description
DRUG	pioglitazone group: lifestyle intervention+ metformin+ orlistat (obese patients)+ pioglitazone	the pioglitazone group： classic treatment: lifestyle intervention+ metformin+ orlistat (obese patients)+ pioglitazone
DRUG	the Chiglitazar group: lifestyle intervention+ metformin+ orlistat (obese patients)+ Chiglitazar	the Chiglitazar group: lifestyle intervention+ metformin+ orlistat (obese patients)+ Chiglitazar (32mg QD)

Timeline

• Start date: 2022-10-01
• Primary completion: 2023-09-30
• Completion: 2024-09-30
• First posted: 2023-03-08
• Last updated: 2023-08-01

Locations

1 site across 1 country: China