Efficacy of Dapagliflozin Versus Metformin in Polycystic Ovary Syndrome

Phase 3

Recruiting

• Conditions: Polycystic Ovary Syndrome
• Interventions: Drug: Dapagliflozin; Drug: Metformin

• Registration Number: NCT06576375
• Lead Sponsor: Future University in Egypt

Brief Summary

In PCOS (Polycystic Ovary Syndrome), studies have found impaired incretin secretion and activity, particularly in overweight/obese individuals.

Conflicting results exist regarding glucagon-like peptide-1(GLP-1) levels in PCOS patients, with studies reporting reduced, normal, or increased levels. Incretin-based therapy has been suggested as a potential treatment to reverse prediabetes risk by preserving β-cell function in patients with impaired fasting glucose(IFG and impaired glucose tolerance(IGT). The study aims to compare the efficacy of Dapagliflozin to Metformin for the treatment of non-diabetic patients with polycystic ovary syndrome (PCOS).

Detailed Description

Incretins such as glucagon-like peptide-1(GLP-1) are gut hormones secreted after meals that enhance insulin secretion and help maintain glucose homeostasis.They also reduce hepatic glucagon release, slow gastric emptying, and suppress appetite, aiding in weight control and glycemic management.In PCOS (Polycystic Ovary Syndrome), studies have found impaired incretin secretion and activity, particularly in overweight/obese individuals.Conflicting results exist regarding GLP-1 levels in PCOS patients, with studies reporting reduced, normal, or increased levels.After an oral glucose tolerance test, increased GIP and lower GLP-1 concentrations have been observed in women with PCOS.

Reduced GLP-1 levels are also associated with impaired glucose tolerance (IGT) and impaired fasting glucose (IFG), which are early indicators of prediabetes and potential progression to Type 2 Diabetes Mellitus.Incretin-based therapy has been suggested as a potential treatment to reverse prediabetes risk by preserving β-cell function in patients with IFG and IGT. The study aims to compare the efficacy of Dapagliflozin to Metformin for treatment of non-diabetic patients with polycystic ovary syndrome (PCOS).

Study Timeline

• Status Verified: 2024-08
• Study First Submitted: 2024-08-23
• Study First Submitted QC: 2024-08-26
• Study First Posted: 2024-08-28
• Study Start: 2024-09-02
• Last Update Submitted: 2024-10-18
• Last Update Posted: 2024-10-22
• Primary Completion: 2025-01
• Study Completion: 2025-01

Recruitment & Eligibility

• Status: RECRUITING
• Sex: Female
• Target Recruitment: 70

Inclusion Criteria

• Women diagnosed with PCOS according to Rotterdam 2003 criteria National Institute of Health criteria.
• Age: >18 <40 years.
• Infertile women (primary or secondary infertility)

Exclusion Criteria

• Patients with history of diabetes mellitus (Type 1 or 2).
• Patients with liver or renal dysfunction; inflammatory diseases; autoimmune disease; cancer, acute cardiovascular event within last three months and uncontrolled endocrine or metabolic disease.
• Use of hormonal medications, lipid-lowering (statins, etc.), anti-obesity drugs or weight loss medications (prescription or OTC) and medications known to exacerbate glucose tolerance (such as isotretinoin, hormonal contraceptives, glucocorticoids, anabolic steroids) stopped for at least 8 weeks. Use of anti-androgens that act peripherally to reduce hirsutism such as 5-alpha reductase inhibitors stopped for at least 4 weeks.
• Patients at risk for volume depletion due to co-existing conditions or concomitant medications, such as loop diuretics should have careful monitoring of their volume status.
• Presence of hypersensitivity to dapagliflozin or other Sodium/glucose cotransporter 2 (SGLT2) inhibitors (e.g. anaphylaxis, angioedema, exfoliative skin conditions).
• Use of Metformin, Thiazolidinediones, glucagon-like peptide-1 (GLP-1) receptor agonists, DPP-4 inhibitors, SGLT2 inhibitors
• Eating disorders (anorexia, bulimia) or gastrointestinal disorders.
• Having a history of bariatric surgery.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Dapagliflozin	Dapagliflozin	Patients will receive Dapagliflozin 10 mg once daily orally for 12 weeks (Forxiga® AstraZeneca company)
Metformin	Metformin	Patients will receive Metformin 1000 mg once daily orally for 12 weeks (control group) (Glucophage® Merck company)

Primary Outcome Measures

Name	Time	Method
Fertility parameters- Luteinizing hormone	3-6 months	Luteinizing hormone (LH) in IU/L
Fertility parameters-Free androgen index	3-6 months	Free androgen index \[ Time Frame: 3-6 months\]
Fertility parameters-Total testosterone	3-6 months	Total testosterone in ng/dL
Menstrual diaries	3-6 months	Menstruation pattern
Fertility parameters-Follicle-stimulating hormone	3-6 months	Follicle-stimulating hormone (FSH) in mIU/mL
Transvaginal ultrasonography	3-6 months	disappearance of PCOS

Secondary Outcome Measures

Name	Time	Method
Metabolic parameters	3-6 months	Fasting blood glucose (FBG) in mg/dL

Trial Locations

Locations (1)

October 6 University Hospital; 🇪🇬 Giza, Egypt