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

A

Affiliated Hospital of Nantong University

Status and phase

Invitation-only
Phase 1

Conditions

PCOS (Polycystic Ovary Syndrome) of Bilateral Ovaries
T2D

Treatments

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

Study type

Interventional

Funder types

Other

Identifiers

NCT05760677
Chiglitazar sodium

Details and patient eligibility

About

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.

Full 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.

Enrollment

142 estimated patients

Sex

Female

Ages

Under 40 years old

Volunteers

No Healthy Volunteers

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

Trial design

Primary purpose

Treatment

Allocation

Randomized

Interventional model

Parallel Assignment

Masking

None (Open label)

142 participants in 2 patient groups

Pioglitazone group
Active Comparator group
Description:
All participants were treated with lifestyle intervention+ metformin(0.5g bid po)+ orlistat (0.12g bid po) (obese patients)+ pioglitazone (15mg qd po)
Treatment:
Drug: the Chiglitazar group: lifestyle intervention+ metformin+ orlistat (obese patients)+ Chiglitazar
Drug: pioglitazone group: lifestyle intervention+ metformin+ orlistat (obese patients)+ pioglitazone
Chiglitazar group
Experimental group
Description:
All participants were treated with lifestyle intervention+ metformin(0.5g bid po)+ orlistat (0.12g bid po) (obese patients)+ Chiglitazar (32mg QD)
Treatment:
Drug: the Chiglitazar group: lifestyle intervention+ metformin+ orlistat (obese patients)+ Chiglitazar
Drug: pioglitazone group: lifestyle intervention+ metformin+ orlistat (obese patients)+ pioglitazone

Trial contacts and locations

1

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Data sourced from clinicaltrials.gov

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