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

This study is ongoing, but not recruiting participants.
Chief Scientist Office of the Scottish Government
Information provided by (Responsible Party):
University of Edinburgh
ClinicalTrials.gov Identifier:
First received: February 11, 2014
Last updated: December 3, 2015
Last verified: December 2015

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 Intervention Phase
Gestational Diabetes
Drug: Glibenclamide
Drug: Insulin
Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: A Feasibility Study Looking at the Use of Glibenclamide and metfoRmin Versus stAndard Care in gEstational diabeteS

Resource links provided by NLM:

Further study details as provided by University of Edinburgh:

Primary Outcome Measures:
  • Number of women willing to be randomised [ Time Frame: 2 years ] [ Designated as safety issue: No ]
    • 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 Outcome Measures:
  • Glycaemic control [ Time Frame: 2 weekly ] [ Designated as safety issue: Yes ]
    Safety - number of hypoglycaemic episodes needing treatment, any other adverse events

  • Patient satisfaction [ Time Frame: 36-38 weeks gestation ] [ Designated as safety issue: No ]
    assessed by visual analogue scale

  • Clinical outcomes [ Time Frame: 36 weeks ] [ Designated as safety issue: No ]
    Change in maternal weight between booking and 36 weeks

  • Clinical outcome [ Time Frame: 40 weeks ] [ Designated as safety issue: No ]
    Mode and gestation of delivery.

  • Clinical Outcome [ Time Frame: 40 weeks ] [ Designated as safety issue: No ]
    Birthweight centile (adjusted for sex and gestation at birth)

  • Clinical Outcome [ Time Frame: 2 days ] [ Designated as safety issue: Yes ]
    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)

Enrollment: 23
Study Start Date: July 2014
Estimated Study Completion Date: April 2016
Primary Completion Date: October 2015 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: Current Standard Care
Insulin + Metformin
Drug: Insulin
Active Comparator: Treatment
Glibenclamide + Metformin
Drug: Glibenclamide


Ages Eligible for Study:   16 Years to 50 Years
Genders 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.
  Contacts and Locations
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Please refer to this study by its ClinicalTrials.gov identifier: 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
Sponsors and Collaborators
University of Edinburgh
Chief Scientist Office of the Scottish Government
Principal Investigator: Jane E Norman, MD University of Edinburgh
  More Information

Responsible Party: University of Edinburgh
ClinicalTrials.gov Identifier: NCT02080377     History of Changes
Other Study ID Numbers: GRACES  2013-004706-25 
Study First Received: February 11, 2014
Last Updated: December 3, 2015
Health Authority: United Kingdom: Medicines and Healthcare Products Regulatory Agency
United Kingdom: National Health Service
United Kingdom: Research Ethics Committee

Keywords provided by University of Edinburgh:
Gestational diabetes
Glycaemic control

Additional relevant MeSH terms:
Diabetes, Gestational
Diabetes Mellitus
Endocrine System Diseases
Glucose Metabolism Disorders
Metabolic Diseases
Pregnancy Complications
Hypoglycemic Agents
Pharmacologic Actions
Physiological Effects of Drugs

ClinicalTrials.gov processed this record on May 01, 2016