A Feasibility Study Looking at the Use of Glibenclamide and metfoRmin Versus stAndard Care in gEstational diabeteS (GRACES)
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ClinicalTrials.gov Identifier: NCT02080377 |
Recruitment Status :
Completed
First Posted : March 6, 2014
Last Update Posted : December 8, 2016
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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.
Condition or disease | Intervention/treatment | Phase |
---|---|---|
Pregnancy Gestational Diabetes | Drug: Glibenclamide Drug: Insulin | Phase 3 |
Study Type : | Interventional (Clinical Trial) |
Actual Enrollment : | 23 participants |
Allocation: | Randomized |
Intervention Model: | Single Group Assignment |
Masking: | None (Open Label) |
Primary Purpose: | Treatment |
Official Title: | A Feasibility Study Looking at the Use of Glibenclamide and metfoRmin Versus stAndard Care in gEstational diabeteS |
Study Start Date : | July 2014 |
Actual Primary Completion Date : | October 2015 |
Actual Study Completion Date : | March 2016 |

Arm | Intervention/treatment |
---|---|
Active Comparator: Current Standard Care
Insulin + Metformin
|
Drug: Insulin |
Active Comparator: Treatment
Glibenclamide + Metformin
|
Drug: Glibenclamide |
- 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)
- Glycaemic control [ Time Frame: 2 weekly ]Safety - number of hypoglycaemic episodes needing treatment, any other adverse events
- Patient satisfaction [ Time Frame: 36-38 weeks gestation ]assessed by visual analogue scale
- Clinical outcomes [ Time Frame: 36 weeks ]Change in maternal weight between booking and 36 weeks
- Clinical outcome [ Time Frame: 40 weeks ]Mode and gestation of delivery.
- Clinical Outcome [ Time Frame: 40 weeks ]Birthweight centile (adjusted for sex and gestation at birth)
- 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)

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Ages Eligible for Study: | 16 Years to 50 Years (Child, Adult) |
Sexes Eligible for Study: | Female |
Accepts Healthy Volunteers: | No |
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.

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): NCT02080377
United Kingdom | |
Princess Royal Infirmary | |
Glasgow, Lanarkshire, United Kingdom, G31 2ER | |
Simpson Centre for Reproductive Health, Royal Infirmary Hospital, Edinburgh | |
Edinburgh, Lothian, United Kingdom, EH16 4SA | |
Western General Hospital | |
Edinburgh, Lothian, United Kingdom, EH4 2XU | |
St Johns Hospital | |
Livingston, West Lothian, United Kingdom | |
Queen Elizabeth Hospital | |
Glasgow, United Kingdom |
Principal Investigator: | Jane E Norman, MD | University of Edinburgh |
Responsible Party: | University of Edinburgh |
ClinicalTrials.gov Identifier: | NCT02080377 |
Other Study ID Numbers: |
GRACES 2013-004706-25 ( EudraCT Number ) |
First Posted: | March 6, 2014 Key Record Dates |
Last Update Posted: | December 8, 2016 |
Last Verified: | December 2015 |
Pregnancy Gestational diabetes Glycaemic control Metformin |
Diabetes, Gestational Diabetes Mellitus Glucose Metabolism Disorders Metabolic Diseases Endocrine System Diseases |
Pregnancy Complications Glyburide Hypoglycemic Agents Physiological Effects of Drugs |