Clinical trial · Interventional
Study on the Efficacy and Safety of Chiglitazar Sodium in PCOS With T2DM
Study on the Efficacy and Safety of Chiglitazar Sodium in the Treatment of Polycystic Ovary Syndrome With Type 2 Diabetes
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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.
Conditions
Conditions (2)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| PCOS (Polycystic Ovary Syndrome) of Bilateral Ovaries | — | UNRESOLVED | — |
| T2D | — | UNRESOLVED | — |
Interventions
Interventions (2)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| pioglitazone group: lifestyle intervention+ metformin+ orlistat (obese patients)+ pioglitazone | Drug | — | UNRESOLVED |
| the Chiglitazar group: lifestyle intervention+ metformin+ orlistat (obese patients)+ Chiglitazar | Drug | — | UNRESOLVED |
Design
Arms and outcomes
Arms (2)
- type
- ACTIVE_COMPARATOR
- label
- Pioglitazone 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)
- interventionNames
- Drug: pioglitazone group: lifestyle intervention+ metformin+ orlistat (obese patients)+ pioglitazone
- Drug: the Chiglitazar group: lifestyle intervention+ metformin+ orlistat (obese patients)+ Chiglitazar
- type
- EXPERIMENTAL
- label
- Chiglitazar group
- description
- All participants were treated with lifestyle intervention+ metformin(0.5g bid po)+ orlistat (0.12g bid po) (obese patients)+ Chiglitazar (32mg QD)
- interventionNames
- Drug: pioglitazone group: lifestyle intervention+ metformin+ orlistat (obese patients)+ pioglitazone
- Drug: the Chiglitazar group: lifestyle intervention+ metformin+ orlistat (obese patients)+ Chiglitazar
Primary outcomes (2)
Eligibility
Eligibility (as posted)
- Sex
- Female
- Maximum age
- 40 Years
Show eligibility criteria text
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
References
Publications (0)
Data not yet available