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

Primary Purpose

PCOS (Polycystic Ovary Syndrome) of Bilateral Ovaries, T2D

Status
Enrolling by invitation
Phase
Phase 1
Locations
China
Study Type
Interventional
Intervention
pioglitazone group: lifestyle intervention+ metformin+ orlistat (obese patients)+ pioglitazone
the Chiglitazar group: lifestyle intervention+ metformin+ orlistat (obese patients)+ Chiglitazar
Sponsored by
Affiliated Hospital of Nantong University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for PCOS (Polycystic Ovary Syndrome) of Bilateral Ovaries

Eligibility Criteria

undefined - 40 Years (Child, Adult)FemaleDoes not accept 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

Sites / Locations

  • Gu Yunjuan

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Experimental

Arm Label

Pioglitazone group

Chiglitazar group

Arm Description

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

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

Outcomes

Primary Outcome Measures

Change of plasma glucose
Assessment the change level of plasma glucose. The unit is mmol/L.
The recovery of menstrual cycle
Assessment the recovery of menstrual cycle. The unit is day.

Secondary Outcome Measures

The changes in body weight
Assessment the changes of body weight. The unit is kilogram.

Full Information

First Posted
February 27, 2023
Last Updated
July 28, 2023
Sponsor
Affiliated Hospital of Nantong University
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1. Study Identification

Unique Protocol Identification Number
NCT05760677
Brief Title
Study on the Efficacy and Safety of Chiglitazar Sodium in PCOS With T2DM
Official Title
Study on the Efficacy and Safety of Chiglitazar Sodium in the Treatment of Polycystic Ovary Syndrome With Type 2 Diabetes
Study Type
Interventional

2. Study Status

Record Verification Date
February 2023
Overall Recruitment Status
Enrolling by invitation
Study Start Date
October 1, 2022 (Actual)
Primary Completion Date
September 30, 2023 (Anticipated)
Study Completion Date
September 30, 2024 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Affiliated Hospital of Nantong University

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

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.
Detailed 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
PCOS (Polycystic Ovary Syndrome) of Bilateral Ovaries, T2D

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 1
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
142 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Pioglitazone group
Arm Type
Active Comparator
Arm Description
All participants were treated with lifestyle intervention+ metformin(0.5g bid po)+ orlistat (0.12g bid po) (obese patients)+ pioglitazone (15mg qd po)
Arm Title
Chiglitazar group
Arm Type
Experimental
Arm Description
All participants were treated with lifestyle intervention+ metformin(0.5g bid po)+ orlistat (0.12g bid po) (obese patients)+ Chiglitazar (32mg QD)
Intervention Type
Drug
Intervention Name(s)
pioglitazone group: lifestyle intervention+ metformin+ orlistat (obese patients)+ pioglitazone
Intervention Description
the pioglitazone group： classic treatment: lifestyle intervention+ metformin+ orlistat (obese patients)+ pioglitazone
Intervention Type
Drug
Intervention Name(s)
the Chiglitazar group: lifestyle intervention+ metformin+ orlistat (obese patients)+ Chiglitazar
Intervention Description
the Chiglitazar group: lifestyle intervention+ metformin+ orlistat (obese patients)+ Chiglitazar (32mg QD)
Primary Outcome Measure Information:
Title
Change of plasma glucose
Description
Assessment the change level of plasma glucose. The unit is mmol/L.
Time Frame
12 weeks
Title
The recovery of menstrual cycle
Description
Assessment the recovery of menstrual cycle. The unit is day.
Time Frame
12 weeks
Secondary Outcome Measure Information:
Title
The changes in body weight
Description
Assessment the changes of body weight. The unit is kilogram.
Time Frame
12 weeks

10. Eligibility

Sex
Female
Maximum Age & Unit of Time
40 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Facility Information:
Facility Name
Gu Yunjuan
City
Nantong
State/Province
Jiangsu
ZIP/Postal Code
226001
Country
China

12. IPD Sharing Statement

Plan to Share IPD
Undecided

Learn more about this trial

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

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