| Trial ID: | L7210 |
| Source ID: | NCT05760677
|
| Associated Drug: |
Pioglitazone Group: Lifestyle Intervention+ Metformin+ Orlistat (Obese Patients)+ Pioglitazone
|
| Title: |
Study on the Efficacy and Safety of Chiglitazar Sodium in PCOS With T2DM
|
| Acronym: |
|
| Status: |
UNKNOWN
|
| Study Results: |
NO
|
| Results: |
|
| Conditions: |
PCOS (Polycystic Ovary Syndrome) of Bilateral Ovaries|T2D
|
| Interventions: |
DRUG: pioglitazone group: lifestyle intervention+ metformin+ orlistat (obese patients)+ pioglitazone|DRUG: the Chiglitazar group: lifestyle intervention+ metformin+ orlistat (obese patients)+ Chiglitazar
|
| Outcome Measures: |
Primary: 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: The changes in body weight, Assessment the changes of body weight. The unit is kilogram., 12 weeks
|
| Sponsor/Collaborators: |
Sponsor: Affiliated Hospital of Nantong University
|
| Gender: |
FEMALE
|
| Age: |
CHILD, ADULT
|
| Phases: |
PHASE1
|
| Enrollment: |
142
|
| Study Type: |
INTERVENTIONAL
|
| Study Designs: |
Allocation: RANDOMIZED|Intervention Model: PARALLEL|Masking: NONE|Primary Purpose: TREATMENT
|
| Start Date: |
2022-10-01
|
| Completion Date: |
2024-09-30
|
| Results First Posted: |
|
| Last Update Posted: |
2023-08-01
|
| Locations: |
Gu Yunjuan, Nantong, Jiangsu, 226001, China
|
| URL: |
https://clinicaltrials.gov/show/NCT05760677
|
