Study on the Efficacy and Safety of Chiglitazar Sodium in PCOS With T2DM
Status:
Enrolling by invitation
Trial end date:
2024-09-30
Target enrollment:
Participant gender:
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.