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Empagliflozin vs Metformin in PCOS

Primary Purpose

Polycystic Ovary Syndrome

Status

Completed

Phase

Phase 2

Locations

United Kingdom

Study Type

Interventional

Intervention

Empagliflozin

Metformin

About this trial

This is an interventional health services research trial for Polycystic Ovary Syndrome

Eligibility Criteria

18 Years - 45 Years (Adult)FemaleDoes not accept healthy volunteers

Inclusion Criteria:

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

Exclusion Criteria:

Non-classical 21-hydroxylase deficiency, hyperprolactinaemia, Cushing's disease and androgen-secreting tumours will be excluded by appropriate tests.
Confirmed diagnosis of diabetes or pre-diabetes.
Ongoing, inadequately controlled thyroid disorder (subjects on thyroid hormone replacement therapy must be on stable dose for at least 3 months before screening day)
History or presence of malignant neoplasms within the last 5 years (except basal and squamous cell skin cancer and in-situ carcinoma).
History or plan of any form of gastrointestinal tract surgery.
History of pancreatitis (Acute or Chronic).
Any disorder which in the opinion of the investigator might jeopardize subject's safety.
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
Female who is pregnant, breast feeding or intended to become pregnant or of child bearing potential not using adequate contraceptive methods.
eGFR<60
Hypersensitivity to lactose
Severe hepatic impairment (ALT >3 times ULN)
Women with history of recurrent urinary tract infections.
Haematocrit above the upper limit of normal range.
Have been involved in another medicinal trial (CTIMP) within the past four weeks.
Known hypersensitivity to the Investigational Medicinal Products or any of their excipients.

Sites / Locations

Michael White Centre for Diabetes and Endocrinology

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

Empagliflozin group

Metformin group

Arm Description

Each participant will receive empagliflozin 25mg daily for 3 months

Each participant will receive metformin 1500mg daily for 3 months

Outcomes

Primary Outcome Measures

Endothelial function as measured by RHI (reactive hyperaemia index).

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

Inflammatory markers (hsCRP)

Inflammatory markers (hsCRP) will be assessed after three months treatment with either empagliflozin 25mg or metformin S/R 1500mg daily

Insulin resistance as measured by HOMA (fasting glucose & insulin)

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

Body weight

Body weight will be assessed after three months treatment with either empagliflozin 25mg or metformin S/R 1500mg daily

Blood pressure

Blood pressure will be assessed after three months treatment with either empagliflozin 25mg or metformin S/R 1500mg daily

Lipid profile

Lipid profile will be assessed after three months treatment with either empagliflozin 25mg or metformin S/R 1500mg daily

Hormonal parameters including free androgen index

Hormonal parameters including free androgen index will be assessed after three months treatment with either empagliflozin 25mg or metformin S/R 1500mg daily

Endothelial function measured by microparticles

Endothelial function measured by microparticles will be assessed after three months treatment with either empagliflozin 25mg or metformin S/R 1500mg daily

Quality of life Questionnaire

Quality of life will be assessed after three months treatment with either empagliflozin 25mg or metformin S/R 1500mg daily

Full Information

NCT ID

NCT03008551

First Posted

December 28, 2016

Last Updated

July 11, 2019

Sponsor

Hull University Teaching Hospitals NHS Trust

1. Study Identification

Unique Protocol Identification Number

NCT03008551

Brief Title

Empagliflozin vs Metformin in PCOS

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.

Study Type

Interventional

2. Study Status

Record Verification Date

July 2019

Overall Recruitment Status

Completed

Study Start Date

August 18, 2017 (Actual)

Primary Completion Date

April 2, 2018 (Actual)

Study Completion Date

April 2, 2018 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

Hull University Teaching Hospitals NHS Trust

4. Oversight

Studies a U.S. FDA-regulated Drug Product

Studies a U.S. FDA-regulated Device Product

Data Monitoring Committee

Yes

5. Study Description

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.

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.

6. Conditions and Keywords

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

Polycystic Ovary Syndrome

7. Study Design

Primary Purpose

Health Services Research

Study Phase

Phase 2, Phase 3

Interventional Study Model

Parallel Assignment

Masking

None (Open Label)

Allocation

Randomized

Enrollment

40 (Actual)

8. Arms, Groups, and Interventions

Arm Title

Empagliflozin group

Arm Type

Experimental

Arm Description

Each participant will receive empagliflozin 25mg daily for 3 months

Arm Title

Metformin group

Arm Type

Active Comparator

Arm Description

Each participant will receive metformin 1500mg daily for 3 months

Intervention Type

Drug

Intervention Name(s)

Empagliflozin

Other Intervention Name(s)

Jardiance

Intervention Description

Each participant will receive empagliflozin 25mg daily for 3 months.

Intervention Type

Drug

Intervention Name(s)

Metformin

Other Intervention Name(s)

Glucophage SR

Intervention Description

Each participant will receive metformin 1500mg daily for 3 months.

Primary Outcome Measure Information:

Title

Endothelial function as measured by RHI (reactive hyperaemia index).

Description

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

Time Frame

Three months treatment with either empagliflozin 25mg or metformin 1500mg daily

Secondary Outcome Measure Information:

Title

Inflammatory markers (hsCRP)

Description

Inflammatory markers (hsCRP) will be assessed after three months treatment with either empagliflozin 25mg or metformin S/R 1500mg daily

Time Frame

Three months treatment with either empagliflozin 25mg or metformin 1500mg daily

Title

Insulin resistance as measured by HOMA (fasting glucose & insulin)

Description

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

Time Frame

Three months treatment with either empagliflozin 25mg or metformin 1500mg daily

Title

Body weight

Description

Body weight will be assessed after three months treatment with either empagliflozin 25mg or metformin S/R 1500mg daily

Time Frame

Three months treatment with either empagliflozin 25mg or metformin 1500mg daily

Title

Blood pressure

Description

Blood pressure will be assessed after three months treatment with either empagliflozin 25mg or metformin S/R 1500mg daily

Time Frame

Three months treatment with either empagliflozin 25mg or metformin 1500mg daily

Title

Lipid profile

Description

Lipid profile will be assessed after three months treatment with either empagliflozin 25mg or metformin S/R 1500mg daily

Time Frame

Three months treatment with either empagliflozin 25mg or metformin 1500mg daily

Title

Hormonal parameters including free androgen index

Description

Hormonal parameters including free androgen index will be assessed after three months treatment with either empagliflozin 25mg or metformin S/R 1500mg daily

Time Frame

Three months treatment with either empagliflozin 25mg or metformin 1500mg daily

Title

Endothelial function measured by microparticles

Description

Endothelial function measured by microparticles will be assessed after three months treatment with either empagliflozin 25mg or metformin S/R 1500mg daily

Time Frame

Three months treatment with either empagliflozin 25mg or metformin 1500mg daily

Title

Quality of life Questionnaire

Description

Quality of life will be assessed after three months treatment with either empagliflozin 25mg or metformin S/R 1500mg daily

Time Frame

Three months treatment with either empagliflozin 25mg or metformin S/R 1500mg daily

10. Eligibility

Sex

Female

Minimum Age & Unit of Time

18 Years

Maximum Age & Unit of Time

45 Years

Accepts Healthy Volunteers

Eligibility Criteria

Inclusion Criteria: Women, aged 18-45 years (inclusive), with confirmed diagnosis of PCOS based on Rotterdam criteria. Presence of both irregular periods and biochemical hyperandrogenaemia Body mass index ≥25 Negative pregnancy test during screening visit and agree to use barrier contraception during the study period. Exclusion Criteria: Non-classical 21-hydroxylase deficiency, hyperprolactinaemia, Cushing's disease and androgen-secreting tumours will be excluded by appropriate tests. Confirmed diagnosis of diabetes or pre-diabetes. Ongoing, inadequately controlled thyroid disorder (subjects on thyroid hormone replacement therapy must be on stable dose for at least 3 months before screening day) History or presence of malignant neoplasms within the last 5 years (except basal and squamous cell skin cancer and in-situ carcinoma). History or plan of any form of gastrointestinal tract surgery. History of pancreatitis (Acute or Chronic). Any disorder which in the opinion of the investigator might jeopardize subject's safety. 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 Female who is pregnant, breast feeding or intended to become pregnant or of child bearing potential not using adequate contraceptive methods. eGFR<60 Hypersensitivity to lactose Severe hepatic impairment (ALT >3 times ULN) Women with history of recurrent urinary tract infections. Haematocrit above the upper limit of normal range. Have been involved in another medicinal trial (CTIMP) within the past four weeks. Known hypersensitivity to the Investigational Medicinal Products or any of their excipients.

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Thozhukat Sathyapalan, MBBS FRCP MD

Organizational Affiliation

University of Hull/Hull and East Yorkshire Hospitals NHS Trust

Official's Role

Principal Investigator

Facility Information:

Facility Name

Michael White Centre for Diabetes and Endocrinology

City

Hull

State/Province

East Yorkshire

ZIP/Postal Code

HU3 2RW

Country

United Kingdom

12. IPD Sharing Statement

Plan to Share IPD

Citations:

PubMed Identifier

30866088

Citation

Javed Z, Papageorgiou M, Deshmukh H, Rigby AS, Qamar U, Abbas J, Khan AY, Kilpatrick ES, Atkin SL, Sathyapalan T. Effects of empagliflozin on metabolic parameters in polycystic ovary syndrome: A randomized controlled study. Clin Endocrinol (Oxf). 2019 Jun;90(6):805-813. doi: 10.1111/cen.13968. Epub 2019 Apr 2.

Results Reference

result

Learn more about this trial

Empagliflozin vs Metformin in PCOS

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