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Completed

NCT Number: NCT02080377

A Feasibility Study Looking at the Use of Glibenclamide and metfoRmin Versus stAndard Care in gEstational diabeteS

The aim of this open label feasibility study is to determine recruitment rates to a randomised trial of glibenclamide compared with insulin (both in addition to maximum tolerated metformin) for the treatment of Gestational Diabetes Mellitus (GDM). This feasibility trial will inform the design of a future substantive multicentre trial to test the hypothesis that combination therapy with glibenclamide and metformin could reduce the number of pregnant women with GDM who require insulin and would be superior to metformin and insulin in terms of acceptability and cost effectiveness.

Women with GDM who have "failed" monotherapy with metformin will be recruited and randomised to either receive glibenclamide (test arm) or standard care with insulin, both in addition to their maximum tolerated dose of metformin. Patients will be recruited from three of the antenatal clinics.

This is a feasibility study in preparation for a large multicentre randomised trial to test the hypothesis that the addition of glibenclamide to metformin (combination therapy) could reduce the number of pregnant women with gestational diabetes mellitus requiring insulin, without compromising glycaemic control or other clinical outcomes. The investigators hypothesise that combination therapy with metformin and glibenclamide is likely to be preferable to metformin and insulin in terms of acceptability and cost.

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Key information

Conditions

Pregnancy Diabetes Mellitus Diabetes, Gestational Endocrine System Diseases Female Urogenital Diseases and Pregnancy Complications Gestational Diabetes Glucose Metabolism Disorders Metabolic Diseases Nutritional and Metabolic Diseases Pregnancy Complications Urogenital Diseases

Age range

16 year–50 year

Sex eligibility

Female

Study type

Interventional

Phase

Phase 3

Primary location

Queen Elizabeth Hospital, Glasgow, United Kingdom

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Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Pregnant women diagnosed with gestational diabetes who fail to achieve "adequate glycaemic control" on maximum tolerated dose metformin
  • Inadequate glycaemic control is defined according to the SIGN 116 guidelines.

Exclusion criteria

  • Pregnant women requiring insulin prior to 20 weeks gestation or after 36 weeks gestation.
  • Pregnant women not taking at least 500mg metformin daily.
  • Patients with suspected Type 1 diabetes mellitus presenting in pregnancy.
  • Women with allergies to either glibenclamide or insulin or any of their excipients.
  • Women with any contraindications to sulfonylurea therapy.
  • Women unable to give informed consent.

Treatment and study plan

glibenclamide

Drug

Insulin

Drug

Primary outcomes

  1. Number of women willing to be randomised

    Time frame: 2 years

    • Retention - proportion of women randomised who remain in the study to provide outcomes
    • Adherence - proportion of clinicians who adhere to the treatment regimen(s)

Secondary outcomes

  1. Glycaemic control

    Time frame: 2 weekly

    Safety - number of hypoglycaemic episodes needing treatment, any other adverse events

  2. Patient satisfaction

    Time frame: 36-38 weeks gestation

    assessed by visual analogue scale

  3. Clinical outcomes

    Time frame: 36 weeks

    Change in maternal weight between booking and 36 weeks

  4. Clinical outcome

    Time frame: 40 weeks

    Mode and gestation of delivery.

  5. Clinical Outcome

    Time frame: 40 weeks

    Birthweight centile (adjusted for sex and gestation at birth)

  6. Clinical Outcome

    Time frame: 2 days

    Incidence of neonatal hypoglycaemia (defined as any of the following: blood glucose <2.6 mmol/l) in first 48hrs age, or given intravenous glucose or any other drug to increase blood glucose)

Sponsors and collaborators

Lead sponsor

University of Edinburgh

Other

Collaborators

  • Chief Scientist Office of the Scottish Government

Registry information

Acronym: GRACES

Important dates

Study start
2014
Primary completion
2015
Study completion
2016
First posted
Mar 6, 2014
Registry last updated
Dec 8, 2016

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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