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AzTrials

Polycystic Ovary SyndromePhase 2/3NCT03008551

Empagliflozin vs Metformin in PCOS

A Phase 2/3 study testing Empagliflozin and Metformin in people with Polycystic Ovary Syndrome, run by Hull University Teaching Hospitals NHS Trust at 1 site in United Kingdom.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial 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. Read more about this study

Who is it for?
Ages 18 to 45 years, women only
Conditions the study is for
Polycystic Ovary Syndrome
What is being tested?
Empagliflozin and Metformin
Could I receive a placebo?
No, everyone receives an active treatment
How many people
40 participants
Where
1 siteUnited Kingdom
Study dates
18 Aug 2017to 2 Apr 2018
Phase
Phase 2/3
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 to 45 years
  • Women only
  • No healthy volunteers
  • Adult

Who may be able to join

  • 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.

Who cannot join

  • 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).
Show all 22Show fewer
  • 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.

Trial locations and contacts

1 site in 1 country.

United Kingdom1 site

  • Michael White Centre for Diabetes and Endocrinology

    Hull, East Yorkshire, HU3 2RW

Other trials in United Kingdom

About this study

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.

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.

Read the 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.

Being tested
Empagliflozin, Metformin
Medical subject headings
Polycystic Ovary Syndrome

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • EmpagliflozinDrug

    Also called Jardiance

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

  • MetforminDrug

    Also called Glucophage SR

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

Study groups in NCT03008551
Study groupRoleWhat they receive
Empagliflozin groupExperimentalEach participant will receive empagliflozin 25mg daily for 3 months
Receives: Drug: Empagliflozin
Metformin groupActive comparatorEach participant will receive metformin 1500mg daily for 3 months
Receives: Drug: Metformin

What is being measured

The primary outcome is the main question the study is designed to answer.

  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

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

Secondary outcomes (8)

  1. Inflammatory markers (hsCRP)

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

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

  2. 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

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

  3. Body weight

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

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

  4. Blood pressure

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

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

  5. Lipid profile

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

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

  6. 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

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

  7. 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

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

  8. Quality of life Questionnaire

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

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

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted2 Jan 2017 (estimated)
  2. Study start18 Aug 2017
  3. Primary completion2 Apr 2018
  4. Study completion2 Apr 2018

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 2/3
Primary purpose
Health services research
Allocation
Randomised
Intervention model
Parallel groups
Masking
None (open label)
Enrolment
40 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT03008551
Sponsor's protocol ID
Version 3.0
Status last verified
Jul 2019
First submitted
28 Dec 2016
Last updated
15 Jul 2019
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Publications

  • 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.

    PubMed 30866088

Questions about this trial

What is this clinical trial studying?

A Phase 2/3 study testing Empagliflozin and Metformin in people with Polycystic Ovary Syndrome, run by Hull University Teaching Hospitals NHS Trust at 1 site in United Kingdom.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 4 inclusion and 22 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 15 Jul 2019. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in United Kingdom. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this combined phase mean?

Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Endothelial function as measured by RHI (reactive hyperaemia index). (time frame: Three months treatment with either empagliflozin 25mg or metformin 1500mg daily). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT03008551, which also lists 1 linked publication.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 15 Jul 2019.

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