Empagliflozin vs Metformin in PCOS

NCT03008551 | Completed Phase 2 DMC

• 1 other identifier: Version 3.0
• Study Type: interventional
• Target: 40
• Locations: 1 country
• Sites: 1

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.

Conditions

Polycystic Ovary Syndrome

Outcome Measures

Primary Outcomes (1)

• 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

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

Secondary Outcomes (8)

• Inflammatory markers (hsCRP)

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

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

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

• Body weight

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

• Blood pressure

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

• Lipid profile

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

Study Arms (2)

Empagliflozin group

EXPERIMENTAL

Each participant will receive empagliflozin 25mg daily for 3 months

Drug: Empagliflozin

Metformin group

ACTIVE COMPARATOR

Each participant will receive metformin 1500mg daily for 3 months

Drug: Metformin

Interventions

Empagliflozin DRUG

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

Also known as: Jardiance

Empagliflozin group

Metformin DRUG

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

Also known as: Glucophage SR

Metformin group

Eligibility Criteria

• Age: 18 Years - 45 Years
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Hull University Teaching Hospitals NHS Trust: lead

Study Sites (1)

Michael White Centre for Diabetes and Endocrinology

Hull, East Yorkshire, HU3 2RW, United Kingdom

Location

Related Publications (1)

• 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.

  PMID: 30866088 RESULT

MeSH Terms

Conditions

Polycystic Ovary Syndrome

Interventions

empagliflozin; Metformin

Condition Hierarchy (Ancestors)

Ovarian Cysts; Cysts; Neoplasms; Ovarian Diseases; Adnexal Diseases; Genital Diseases, Female; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Genital Diseases; Gonadal Disorders; Endocrine System Diseases

Intervention Hierarchy (Ancestors)

Biguanides; Guanidines; Amidines; Organic Chemicals

Study Officials

• Thozhukat Sathyapalan, MBBS FRCP MD

  University of Hull/Hull and East Yorkshire Hospitals NHS Trust

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: HEALTH SERVICES RESEARCH
• Intervention Model: PARALLEL
• Sponsor Type: OTHER GOV
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 28, 2016
• First Posted: January 2, 2017
• Study Start: August 18, 2017
• Primary Completion: April 2, 2018
• Study Completion: April 2, 2018
• Last Updated: July 15, 2019

Record last verified: 2019-07

Data Sharing

• IPD Sharing: Will not share

Locations

GB (1)