Efficacy of Empagliflozin or Linagliptin as an Alternative to Metformin for Treatment of Polycystic Ovary Syndrome

Alexandria University

Status and phase: Unknown; Phase 4

Conditions: Polycystic Ovary Syndrome (PCOS)

Treatments: Drug: Metformin 1500 mg; Drug: Empagliflozin 25 mg; Drug: Linagliptin 10 mg

Study type: Interventional

Funder types: Other

Identifiers

NCT05200793

0201566

Details and patient eligibility

About

The study aims to compare the efficacy of Empagliflozin or Linagliptin as an alternative to Metformin for treatment of non-diabetic patients with polycystic ovary syndrome (PCOS).

Full description

Patients with polycystic ovary syndrome will be randomized to three arms:

• Metformin (standard care)
• Empagliflozin or Linagliptin Resolution of the syndrome in addition to normalization of sex hormones, metabolic and inflammatory parameters will be tested

Enrollment: 75 estimated patients

Sex: Female

Ages: 18 to 40 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

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

Exclusion criteria

1. Patients with history of diabetes mellitus (Type 1 or 2).
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.
3. Significantly elevated triglyceride levels (fasting triglyceride > 400 mg/dL)
4. Untreated or poorly controlled hypertension (sitting blood pressure > 160/95 mm Hg).
5. 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.
6. 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.
7. Presence of hypersensitivity to Empagliflozin or other Sodium/glucose cotransporter 2 (SGLT2) inhibitors (e.g. anaphylaxis, angioedema, exfoliative skin conditions).
8. Known hypersensitivity or contraindications to use dipeptidyl peptidase-4 (DPP-4) inhibitors (saxagliptin, linagliptin, sitagliptin...).
9. Use of Metformin, Thiazolidinediones, glucagon-like peptide-1 (GLP-1) receptor agonists, DPP-4 inhibitors, SGLT2 inhibitors stopped for at least 4 weeks.
10. Eating disorders (anorexia, bulimia) or gastrointestinal disorders.
11. Having a history of bariatric surgery.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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75 participants in 3 patient groups

Metformin arm (control group)

Active Comparator group

Description:

Patients will receive Metformin (1500 mg orally/day) for 12 weeks .

Treatment:

Drug: Metformin 1500 mg

Empagliflozin arm

Active Comparator group

Description:

Patients will receive Empagliflozin (25 mg orally/day) for 12 weeks.

Treatment:

Drug: Empagliflozin 25 mg

Linagliptin arm

Active Comparator group

Description:

Patients will receive Linagliptin (10 mg orally/day) for 12 weeks

Treatment:

Drug: Linagliptin 10 mg