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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

UNKNOWN

Clinical Phase

PHASE1

Total Enrollment

142 participants

Study Classification

INTERVENTIONAL

Study Start Date

2022-10-01

Study Completion Date

2024-09-30

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

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.

Related Clinical Trials

Explore similar clinical trials based on study characteristics and research focus.

Chiglitazar/Metformin in Non-obese Women With PCOS

NCT06125587

Polycystic Ovary Syndrome Chiglitazar Metformin

COMPLETED PHASE2/PHASE3

SGLT2 Inhibitors in Treating Patients With PCOS

NCT05966792

Polycystic Ovary Syndrome

ENROLLING_BY_INVITATION NA

SGLT2 Inhibitors in Patients With PCOS

NCT04700839

Polycystic Ovary Syndrome

COMPLETED PHASE4

Effects of Pioglitazone Combined With Metformin on Gonadal and Metabolic Profiles in Chinese Nonobese PCOS Patients.

NCT05519813

Polycystic Ovary Syndrome

UNKNOWN PHASE4

of Sodium Glucose Cotransporter-2 Inhibitors on Metabolic, Hormonal and Clinical Parameters in PCO

NCT05601336

PCO

UNKNOWN PHASE3

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

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

See the medical conditions and disease areas that this research is targeting or investigating.

PCOS (Polycystic Ovary Syndrome) of Bilateral Ovaries T2D

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

Pioglitazone group

All participants were treated with lifestyle intervention+ metformin(0.5g bid po)+ orlistat (0.12g bid po) (obese patients)+ pioglitazone (15mg qd po)

Group Type ACTIVE_COMPARATOR

pioglitazone group: lifestyle intervention+ metformin+ orlistat (obese patients)+ pioglitazone

Intervention Type DRUG

the pioglitazone group： classic treatment: lifestyle intervention+ metformin+ orlistat (obese patients)+ pioglitazone

the Chiglitazar group: lifestyle intervention+ metformin+ orlistat (obese patients)+ Chiglitazar

Intervention Type DRUG

the Chiglitazar group: lifestyle intervention+ metformin+ orlistat (obese patients)+ Chiglitazar (32mg QD)

Chiglitazar group

All participants were treated with lifestyle intervention+ metformin(0.5g bid po)+ orlistat (0.12g bid po) (obese patients)+ Chiglitazar (32mg QD)

Group Type EXPERIMENTAL

pioglitazone group: lifestyle intervention+ metformin+ orlistat (obese patients)+ pioglitazone

Intervention Type DRUG

the pioglitazone group： classic treatment: lifestyle intervention+ metformin+ orlistat (obese patients)+ pioglitazone

the Chiglitazar group: lifestyle intervention+ metformin+ orlistat (obese patients)+ Chiglitazar

Intervention Type DRUG

the Chiglitazar group: lifestyle intervention+ metformin+ orlistat (obese patients)+ Chiglitazar (32mg QD)

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

pioglitazone group: lifestyle intervention+ metformin+ orlistat (obese patients)+ pioglitazone

the pioglitazone group： classic treatment: lifestyle intervention+ metformin+ orlistat (obese patients)+ pioglitazone

Intervention Type DRUG

the Chiglitazar group: lifestyle intervention+ metformin+ orlistat (obese patients)+ Chiglitazar

the Chiglitazar group: lifestyle intervention+ metformin+ orlistat (obese patients)+ Chiglitazar (32mg QD)

Intervention Type DRUG

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

Inclusion Criteria

Clinical diagnosis of Type 2 diabetes mellitus Clinical diagnosis of Polycystic ovarian syndrome Must be able to swallow tablets

Exclusion Criteria

Mental diseases, autoimmune diseases, hematological diseases, malignant tumors, other ovarian diseases (such as ovarian cysts), sexually transmitted diseases Infertility caused by gynecological diseases such as uterine cat's eye disease and other reasons Abnormal function of important organs Congenital adrenocorticosis, hypothyroidism, Cushing's syndrome and other endocrine diseases Patients who have recently prepared or become pregnant

Maximum Eligible Age

40 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

No