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

NCT05760677 · Status: UNKNOWN · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 142

Last updated 2023-08-01

No results posted yet for this study

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.

Conditions

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

Interventions

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)

Sponsors & Collaborators

  • Affiliated Hospital of Nantong University

    lead OTHER

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Max Age
40 Years
Sex
FEMALE
Healthy Volunteers
No

Timeline & Regulatory

Start
2022-10-01
Primary Completion
2023-09-30
Completion
2024-09-30

Countries

  • China

Study Locations

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Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT05760677 on ClinicalTrials.gov