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

NCT05200793 — Phase 4, Unknown, 75 participants, Alexandria University

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A Comparative Clinical Study Evaluating the Efficacy of Empagliflozin or Linagliptin as an Alternative to Metformin for Treatment of Polycystic Ovary Syndrome in Egyptian Women

Registry	NCT05200793
Status	Unknown
Phase	Phase 4
Study type	Interventional; randomized, parallel, masking: none, treatment
Enrollment	75 (Estimated)
Sponsor	Alexandria University (Other)
Conditions	Polycystic Ovary Syndrome (PCOS)
Interventions	Empagliflozin 25 mg, Linagliptin 10 mg, Metformin 1500 mg (Drug)
Dates	start 2021-12-07, primary completion 2022-07-01 (estimated), completion 2022-09-01 (estimated), first posted 2022-01-21, last updated 2022-01-21
Locations	1 site in Egypt

-Summary

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).

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+Detailed 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

+Arms and interventions

Arm	Type	Interventions	Description
Metformin arm (control group)	Active comparator	Drug: Metformin 1500 mg	Patients will receive Metformin (1500 mg orally/day) for 12 weeks .
Empagliflozin arm	Active comparator	Drug: Empagliflozin 25 mg	Patients will receive Empagliflozin (25 mg orally/day) for 12 weeks.
Linagliptin arm	Active comparator	Drug: Linagliptin 10 mg	Patients will receive Linagliptin (10 mg orally/day) for 12 weeks

Empagliflozin 25 mg (Drug), also known as Empagliflozin: This study is to compare the efficacy of Empagliflozin or Linagliptin as an alternative to Metformin for treatment of non-diabetic patients with polycystic ovary syndrome (PCOS)
Linagliptin 10 mg (Drug), also known as Linagliptin: This study is to compare the efficacy of Empagliflozin or Linagliptin as an alternative to Metformin for treatment of non-diabetic patients with polycystic ovary syndrome (PCOS)
Metformin 1500 mg (Drug), also known as Metformin: This study is to compare the efficacy of Empagliflozin or Linagliptin as an alternative to Metformin for treatment of non-diabetic patients with polycystic ovary syndrome (PCOS)

+Outcome measures

Primary outcomes

Fertility parameters [3-6 months]: \[luteinizing hormone (LH)
Follicle-stimulating hormone [3-6 months]: FSH
Free androgen index [3-6 months]: total testosterone \& sex hormone binding globulin (SHBG)
Transvaginal ultrasonography [3-6 months]: disappearance of PCOS
Menstrual diaries [3-6 months]: regulate menses cycles

Secondary outcomes

Metabolic parameters [3-6 months]: Fasting blood glucose level
Lipid profile (metabolic parameters) [3-6 months]: Total cholesterol, Low density lipoprotein (LDL), very low density lipoprotein (VLDL), high density lipoprotein (HDL), triglycerides (TG), atherogenic index I, II
Inflammatory indices [3-6 months]: Interleukin 6 or Toll Like receptor 2

+Eligibility

Sex: Female, ages: 18 Years to 40 Years

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.

+Locations (1)

Facility	City	Country	Status
Alexandria University	Alexandria	Egypt	Recruiting

+Investigators

Hanan N Abdel Hafez, PhD, Study chair, Professor of Obstetrics and Gynecology, Faculty of Medicine Mansoura University
Ahmed I ElMallah, PhD, Principal investigator, Professor of Pharmacology and Therapeutics, Faculty of Pharmacy Alexandria University