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A clinical trial to compare the efficacy of combination therapy of antidiabetic drugs dapagliflozin & metformin versus metformin alone in improving metabolic profile in overweight & obese women with polycystic ovary syndrome.

Efficacy of treatment with combination dapagliflozin & metformin versus metformin alone in improving insulin resistance and hyperandrogenemia in overweight and obese women with polycystic ovary syndrome.

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
CTRI
Registry ID
CTRI/2023/06/054098
Enrollment
70
Registered
2023-06-19
Start date
Unknown
Completion date
Unknown
Last updated
2023-06-26

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Health Condition 1: E888- Other specified metabolic disorders Health Condition 2: E66- Overweight and obesity

Interventions

Intervention1: Dapagliflozin and Metformin: Intervention group will receive Dapagliflozin 10 mg once daily and Metformin 1000 mg twice daily per orally for a duration of 24 weeks. Control Intervention

Sponsors

Dr Vishal Agarwal
Lead Sponsor
Dr Arun Choudhury
Collaborator

Eligibility

Inclusion criteria

Inclusion criteria: 1)Body mass index (BMI) more than or equal to 23 kg/m2 2)PCOS diagnosis by Rotterdam 2003 criteria 3)No pregnancy plans within next 6 months

Exclusion criteria

Exclusion criteria: 1)Women who are pregnant or plan to become pregnant 2)Serious liver dysfunction or chronic kidney disease (AST or ALT > 3 times the upper limit of normal, or eGFR 5% current body weight) or have a history of gastrointestinal surgery.

Design outcomes

Primary

MeasureTime frame
1.Improvement in insulin resistance. Change in insulin resistance assessed by insulin sensitivity index- Homeostatic Model Assessment of Insulin Resistance (HOMA-IR). 2.Improvement in free testosterone index. 3.Change in serum sex hormone binding globulin(SHBG). 4.Net change in total testosterone (TT) level. Timepoint: Baseline 12 weeks 24 weeks—

Secondary

MeasureTime frame
1.Net change in waist circumference. 2.Net change in body weight. 3.Net change in body mass index. 4.Net change in fasting glucose. 5.Net change in fasting insulin. 6.Net change in fasting lipid profile: triglyceride levels, total cholesterol & low density lipoprotein cholesterol levels. Timepoint: Baseline 12 weeks 24 weeks—

Countries

India

Contacts

Public ContactVishal Agarwal

Kalinga Institute of Medical Sciences

arunchou39@gmail.com9338055566

Outcome results

None listed

Source: CTRI (via WHO ICTRP) · Data processed: Feb 4, 2026