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Trial record 15 of 186 for:    BI10773

Empagliflozin vs Metformin in PCOS

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ClinicalTrials.gov Identifier: NCT03008551
Recruitment Status : Completed
First Posted : January 2, 2017
Last Update Posted : October 31, 2018
Sponsor:
Information provided by (Responsible Party):
Thozhukat Sathyapalan, University of Hull

Brief Summary:
This a randomised open-label parallel study involving women with polycystic ovary syndrome (PCOS). The patients will be randomised either to metformin 1500mg or empagliflozin 25mg daily for three months. The aim of the study is to examine the effect of empagliflozin on hormonal, metabolic and cardiovascular risk markers and quality of life in women with PCOS.

Condition or disease Intervention/treatment Phase
Polycystic Ovary Syndrome Drug: Empagliflozin Drug: Metformin Phase 2 Phase 3

Detailed Description:

Polycystic ovary syndrome (PCOS) is a very common condition in women that may present with irregular periods, excessive hair growth on the face and body, acne and cysts in the ovaries. PCOS is also associated with increased risk of problems later in life like diabetes, high cholesterol levels and heart disease.

In this study, a medication named Empagliflozin will be tested. Empagliflozin belongs to a class of medicines known as SGLT-2 inhibitors. SGLT-2 stands for sodium glucose co-transporter 2. Empagliflozin, in simple terms, helps in reducing high blood glucose levels by increasing the amount of glucose passed in your urine. This medicine is usually used in patients with type 2 diabetes and has led to improved blood pressure and weight loss in addition to improving blood glucose levels.

We want to give Empagliflozin to women with PCOS to see its effect on hormones related to PCOS and the risk factors for diabetes and heart disease. We will be comparing its effects to metformin (another drug for diabetes) which has already been used in PCOS with very good results.


Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 40 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Health Services Research
Official Title: The Effect of Empagliflozin Versus Metformin on Hormonal, Metabolic and Cardiovascular Risk Factors in Patients With Polycystic Ovary Syndrome (PCOS) - a Randomised Open-label Parallel Study.
Actual Study Start Date : August 18, 2017
Actual Primary Completion Date : April 2, 2018
Actual Study Completion Date : April 2, 2018

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: Empagliflozin group
Each participant will receive empagliflozin 25mg daily for 3 months
Drug: Empagliflozin
Each participant will receive empagliflozin 25mg daily for 3 months.
Other Name: Jardiance

Active Comparator: Metformin group
Each participant will receive metformin 1500mg daily for 3 months
Drug: Metformin
Each participant will receive metformin 1500mg daily for 3 months.
Other Name: Glucophage SR




Primary Outcome Measures :
  1. Endothelial function as measured by RHI (reactive hyperaemia index). [ Time Frame: Three months treatment with either empagliflozin 25mg or metformin 1500mg daily ]
    Endothelial function as measured by RHI (reactive hyperaemia index) will be assessed after three months treatment with either empagliflozin 25mg or metformin S/R 1500mg daily


Secondary Outcome Measures :
  1. Inflammatory markers (hsCRP) [ Time Frame: Three months treatment with either empagliflozin 25mg or metformin 1500mg daily ]
    Inflammatory markers (hsCRP) will be assessed after three months treatment with either empagliflozin 25mg or metformin S/R 1500mg daily

  2. Insulin resistance as measured by HOMA (fasting glucose & insulin) [ Time Frame: Three months treatment with either empagliflozin 25mg or metformin 1500mg daily ]
    Insulin resistance as measured by HOMA (fasting glucose & insulin) will be assessed after three months treatment with either empagliflozin 25mg or metformin S/R 1500mg daily

  3. Body weight [ Time Frame: Three months treatment with either empagliflozin 25mg or metformin 1500mg daily ]
    Body weight will be assessed after three months treatment with either empagliflozin 25mg or metformin S/R 1500mg daily

  4. Blood pressure [ Time Frame: Three months treatment with either empagliflozin 25mg or metformin 1500mg daily ]
    Blood pressure will be assessed after three months treatment with either empagliflozin 25mg or metformin S/R 1500mg daily

  5. Lipid profile [ Time Frame: Three months treatment with either empagliflozin 25mg or metformin 1500mg daily ]
    Lipid profile will be assessed after three months treatment with either empagliflozin 25mg or metformin S/R 1500mg daily

  6. Hormonal parameters including free androgen index [ Time Frame: Three months treatment with either empagliflozin 25mg or metformin 1500mg daily ]
    Hormonal parameters including free androgen index will be assessed after three months treatment with either empagliflozin 25mg or metformin S/R 1500mg daily

  7. Endothelial function measured by microparticles [ Time Frame: Three months treatment with either empagliflozin 25mg or metformin 1500mg daily ]
    Endothelial function measured by microparticles will be assessed after three months treatment with either empagliflozin 25mg or metformin S/R 1500mg daily

  8. Quality of life [ Time Frame: Three months treatment with either empagliflozin 25mg or metformin S/R 1500mg daily ]
    Quality of life will be assessed after three months treatment with either empagliflozin 25mg or metformin S/R 1500mg daily



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Ages Eligible for Study:   18 Years to 45 Years   (Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  1. Women, aged 18-45 years (inclusive), with confirmed diagnosis of PCOS based on Rotterdam criteria.
  2. Presence of both irregular periods and biochemical hyperandrogenaemia
  3. Body mass index ≥25
  4. Negative pregnancy test during screening visit and agree to use barrier contraception during the study period.

Exclusion Criteria:

  1. Non-classical 21-hydroxylase deficiency, hyperprolactinaemia, Cushing's disease and androgen-secreting tumours will be excluded by appropriate tests.
  2. Confirmed diagnosis of diabetes or pre-diabetes.
  3. Ongoing, inadequately controlled thyroid disorder (subjects on thyroid hormone replacement therapy must be on stable dose for at least 3 months before screening day)
  4. History or presence of malignant neoplasms within the last 5 years (except basal and squamous cell skin cancer and in-situ carcinoma).
  5. History or plan of any form of gastrointestinal tract surgery.
  6. History of pancreatitis (Acute or Chronic).
  7. Any disorder which in the opinion of the investigator might jeopardize subject`s safety.
  8. Subjects who are on any of the following medications within 3 months of recruitment:

    • Metformin or other insulin-sensitizing medications (e.g., pioglitazone )
    • Hormonal contraceptives (e.g., birth control pills, hormone-releasing implants, etc.)
    • Anti-androgens (e.g., spironolactone, flutamide, finasteride, etc.)
    • Clomiphene citrate or estrogen modulators such as letrozole
    • GnRH modulators such as leuprolide
    • Minoxidil
  9. Female who is pregnant, breast feeding or intended to become pregnant or of child bearing potential not using adequate contraceptive methods.
  10. eGFR<60
  11. Hypersensitivity to lactose
  12. Severe hepatic impairment (ALT >3 times ULN)
  13. Women with history of recurrent urinary tract infections.
  14. Haematocrit above the upper limit of normal range.
  15. Have been involved in another medicinal trial (CTIMP) within the past four weeks.
  16. Known hypersensitivity to the Investigational Medicinal Products or any of their excipients.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03008551


Locations
United Kingdom
Michael White Centre for Diabetes and Endocrinology
Hull, East Yorkshire, United Kingdom, HU3 2RW
Sponsors and Collaborators
University of Hull
Investigators
Principal Investigator: Thozhukat Sathyapalan, MBBS FRCP MD University of Hull/Hull and East Yorkshire Hospitals NHS Trust

Responsible Party: Thozhukat Sathyapalan, Professor, University of Hull
ClinicalTrials.gov Identifier: NCT03008551     History of Changes
Other Study ID Numbers: Version 3.0
First Posted: January 2, 2017    Key Record Dates
Last Update Posted: October 31, 2018
Last Verified: October 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Additional relevant MeSH terms:
Empagliflozin
Syndrome
Polycystic Ovary Syndrome
Disease
Pathologic Processes
Ovarian Cysts
Cysts
Neoplasms
Ovarian Diseases
Adnexal Diseases
Genital Diseases, Female
Gonadal Disorders
Endocrine System Diseases
Metformin
Hypoglycemic Agents
Physiological Effects of Drugs