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

Primary Purpose

Polycystic Ovary Syndrome (PCOS)

Status

Recruiting

Phase

Phase 4

Locations

Egypt

Study Type

Interventional

Intervention

Empagliflozin 25 mg

Linagliptin 10 mg

Metformin 1500 mg

About this trial

This is an interventional treatment trial for Polycystic Ovary Syndrome (PCOS) focused on measuring PCOS, Empagliflozin, Linagliptin, Metformin

Eligibility Criteria

18 Years - 40 Years (Adult)FemaleDoes not accept healthy volunteers

Inclusion Criteria:

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

Sites / Locations

Alexandria UniversityRecruiting

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Active Comparator

Arm Label

Metformin arm (control group)

Empagliflozin arm

Linagliptin arm

Arm Description

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

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

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

Outcomes

Primary Outcome Measures

Fertility parameters

[luteinizing hormone (LH)

Follicle-stimulating hormone

FSH

Free androgen index

total testosterone & sex hormone binding globulin (SHBG)

Transvaginal ultrasonography

disappearance of PCOS

Menstrual diaries

regulate menses cycles

Secondary Outcome Measures

Metabolic parameters

Fasting blood glucose level

Lipid profile (metabolic parameters)

Total cholesterol, Low density lipoprotein (LDL), very low density lipoprotein (VLDL), high density lipoprotein (HDL), triglycerides (TG), atherogenic index I, II

Inflammatory indices

Interleukin 6 or Toll Like receptor 2

Full Information

NCT ID

NCT05200793

First Posted

December 12, 2021

Last Updated

January 14, 2022

Sponsor

Alexandria University

1. Study Identification

Unique Protocol Identification Number

NCT05200793

Brief Title

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

Official Title

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

Study Type

Interventional

2. Study Status

Record Verification Date

January 2022

Overall Recruitment Status

Recruiting

Study Start Date

December 7, 2021 (Actual)

Primary Completion Date

July 1, 2022 (Anticipated)

Study Completion Date

September 1, 2022 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Principal Investigator

Name of the Sponsor

Alexandria University

4. Oversight

Studies a U.S. FDA-regulated Drug Product

Studies a U.S. FDA-regulated Device Product

Data Monitoring Committee

5. Study Description

Brief 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).

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

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Polycystic Ovary Syndrome (PCOS)

Keywords

PCOS, Empagliflozin, Linagliptin, Metformin

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 4

Interventional Study Model

Parallel Assignment

Masking

None (Open Label)

Allocation

Randomized

Enrollment

75 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title

Metformin arm (control group)

Arm Type

Active Comparator

Arm Description

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

Arm Title

Empagliflozin arm

Arm Type

Active Comparator

Arm Description

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

Arm Title

Linagliptin arm

Arm Type

Active Comparator

Arm Description

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

Intervention Type

Drug

Intervention Name(s)

Empagliflozin 25 mg

Other Intervention Name(s)

Empagliflozin

Intervention Description

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)

Intervention Type

Drug

Intervention Name(s)

Linagliptin 10 mg

Other Intervention Name(s)

Linagliptin

Intervention Description

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)

Intervention Type

Drug

Intervention Name(s)

Metformin 1500 mg

Other Intervention Name(s)

Metformin

Intervention Description

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)

Primary Outcome Measure Information:

Title

Fertility parameters

Description

[luteinizing hormone (LH)

Time Frame

3-6 months

Title

Follicle-stimulating hormone

Description

FSH

Time Frame

3-6 months

Title

Free androgen index

Description

total testosterone & sex hormone binding globulin (SHBG)

Time Frame

3-6 months

Title

Transvaginal ultrasonography

Description

disappearance of PCOS

Time Frame

3-6 months

Title

Menstrual diaries

Description

regulate menses cycles

Time Frame

3-6 months

Secondary Outcome Measure Information:

Title

Metabolic parameters

Description

Fasting blood glucose level

Time Frame

3-6 months

Title

Lipid profile (metabolic parameters)

Description

Total cholesterol, Low density lipoprotein (LDL), very low density lipoprotein (VLDL), high density lipoprotein (HDL), triglycerides (TG), atherogenic index I, II

Time Frame

3-6 months

Title

Inflammatory indices

Description

Interleukin 6 or Toll Like receptor 2

Time Frame

3-6 months

10. Eligibility

Sex

Female

Gender Based

Yes

Gender Eligibility Description

This study is for the treatment of polycystic ovary syndrome (PCOS)

Minimum Age & Unit of Time

18 Years

Maximum Age & Unit of Time

40 Years

Accepts Healthy Volunteers

Eligibility Criteria

Inclusion Criteria: Women diagnosed with PCOS according to 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. Significantly elevated triglyceride levels (fasting triglyceride > 400 mg/dL) Untreated or poorly controlled hypertension (sitting blood pressure > 160/95 mm Hg). 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 Empagliflozin or other Sodium/glucose cotransporter 2 (SGLT2) inhibitors (e.g. anaphylaxis, angioedema, exfoliative skin conditions). Known hypersensitivity or contraindications to use dipeptidyl peptidase-4 (DPP-4) inhibitors (saxagliptin, linagliptin, sitagliptin…). Use of Metformin, Thiazolidinediones, glucagon-like peptide-1 (GLP-1) receptor agonists, DPP-4 inhibitors, SGLT2 inhibitors stopped for at least 4 weeks. Eating disorders (anorexia, bulimia) or gastrointestinal disorders. Having a history of bariatric surgery.

Central Contact Person:

First Name & Middle Initial & Last Name or Official Title & Degree

Haidy M Sami, Master

Phone

+201015299642

gs-haidy.sami@alexu.edu.eg

First Name & Middle Initial & Last Name or Official Title & Degree

Noha A Hamdy, PhD

Phone

+201005182151

noha.alaaeldine@alexu.edu.eg

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Hanan N Abdel Hafez, PhD

Organizational Affiliation

Professor of Obstetrics and Gynecology, Faculty of Medicine Mansoura University

Official's Role

Study Chair

First Name & Middle Initial & Last Name & Degree

Ahmed I ElMallah, PhD

Organizational Affiliation

Professor of Pharmacology and Therapeutics, Faculty of Pharmacy Alexandria University

Official's Role

Principal Investigator

Facility Information:

Facility Name

Alexandria University

City

Alexandria

ZIP/Postal Code

21521

Country

Egypt

Individual Site Status

Recruiting

Facility Contact:

First Name & Middle Initial & Last Name & Degree

Ahmed I ElMallah, PhD

Phone

+201001708794

ahmed.elmallah@alexu.edu.eg]

First Name & Middle Initial & Last Name & Degree

Hanan N Abdel Hafez, PhD

First Name & Middle Initial & Last Name & Degree

Noha A Hamdy, PhD

First Name & Middle Initial & Last Name & Degree

Haidi M Sami, Master

12. IPD Sharing Statement

Learn more about this trial

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

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