NCT05760677

Brief 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.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
142

participants targeted

Target at P75+ for phase_1

Timeline
Completed

Started Oct 2022

Typical duration for phase_1

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

October 1, 2022

Completed
5 months until next milestone

First Submitted

Initial submission to the registry

February 27, 2023

Completed
9 days until next milestone

First Posted

Study publicly available on registry

March 8, 2023

Completed
7 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 30, 2023

Completed
1 year until next milestone

Study Completion

Last participant's last visit for all outcomes

September 30, 2024

Completed
Last Updated

August 1, 2023

Status Verified

February 1, 2023

Enrollment Period

12 months

First QC Date

February 27, 2023

Last Update Submit

July 28, 2023

Conditions

PCOS (Polycystic Ovary Syndrome) of Bilateral OvariesT2D

Outcome Measures

Primary Outcomes (2)

  • Change of plasma glucose

    Assessment the change level of plasma glucose. The unit is mmol/L.

    12 weeks

  • The recovery of menstrual cycle

    Assessment the recovery of menstrual cycle. The unit is day.

    12 weeks

Secondary Outcomes (1)

  • The changes in body weight

    12 weeks

Study Arms (2)

Pioglitazone group

ACTIVE COMPARATOR

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

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

Chiglitazar group

EXPERIMENTAL

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

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

Interventions

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

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

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

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

Chiglitazar groupPioglitazone group

Eligibility Criteria

AgeUp to 40 Years
Sexfemale
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64)

You may qualify if:

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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Gu Yunjuan

Nantong, Jiangsu, 226001, China

Location

MeSH Terms

Conditions

Polycystic Ovary Syndrome

Condition Hierarchy (Ancestors)

Ovarian CystsCystsNeoplasmsOvarian DiseasesAdnexal DiseasesGenital Diseases, FemaleFemale Urogenital DiseasesFemale Urogenital Diseases and Pregnancy ComplicationsUrogenital DiseasesGenital DiseasesGonadal DisordersEndocrine System Diseases

Study Design

Study Type
interventional
Phase
phase 1
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

February 27, 2023

First Posted

March 8, 2023

Study Start

October 1, 2022

Primary Completion

September 30, 2023

Study Completion

September 30, 2024

Last Updated

August 1, 2023

Record last verified: 2023-02

Locations

CN(1)