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Trial Title:
Study on the Efficacy and Safety of Chiglitazar Sodium in PCOS With T2DM
NCT ID:
NCT05760677
Condition:
PCOS (Polycystic Ovary Syndrome) of Bilateral Ovaries
T2D
Conditions: Official terms:
Polycystic Ovary Syndrome
Syndrome
Metformin
Pioglitazone
Orlistat
Study type:
Interventional
Study phase:
Phase 1
Overall status:
Enrolling by invitation
Study design:
Allocation:
Randomized
Intervention model:
Parallel Assignment
Primary purpose:
Treatment
Masking:
None (Open Label)
Intervention:
Intervention type:
Drug
Intervention name:
pioglitazone group: lifestyle intervention+ metformin+ orlistat (obese patients)+ pioglitazone
Description:
the pioglitazone group： classic treatment: lifestyle intervention+ metformin+ orlistat
(obese patients)+ pioglitazone
Arm group label:
Chiglitazar group
Arm group label:
Pioglitazone group
Intervention type:
Drug
Intervention name:
the Chiglitazar group: lifestyle intervention+ metformin+ orlistat (obese patients)+ Chiglitazar
Description:
the Chiglitazar group: lifestyle intervention+ metformin+ orlistat (obese patients)+
Chiglitazar (32mg QD)
Arm group label:
Chiglitazar group
Arm group label:
Pioglitazone group
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.
Criteria for 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
Gender:
Female
Minimum age:
N/A
Maximum age:
40 Years
Healthy volunteers:
No
Locations:
Facility:
Name:
Gu Yunjuan
Address:
City:
Nantong
Zip:
226001
Country:
China
Start date:
October 1, 2022
Completion date:
September 30, 2024
Lead sponsor:
Agency:
Affiliated Hospital of Nantong University
Agency class:
Other
Source:
Affiliated Hospital of Nantong University
Record processing date:
ClinicalTrials.gov processed this data on November 12, 2024
Source: ClinicalTrials.gov page:
https://clinicaltrials.gov/ct2/show/NCT05760677
