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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
Sponsor:
Collaborator:
Chief Scientist Office of the Scottish Government
Information provided by (Responsible Party):
University of Edinburgh

Study Description
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Brief Summary:

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 Design
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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

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Arms and Interventions
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Arm Intervention/treatment
Active Comparator: Current Standard Care
Insulin + Metformin
 Drug: Insulin
Active Comparator: Treatment
Glibenclamide + Metformin
 Drug: Glibenclamide


Outcome Measures
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Primary Outcome Measures :
  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 Outcome Measures :
  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)


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

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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Information from the National Library of Medicine

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


Locations
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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
Investigators
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Principal Investigator: Jane E Norman, MD University of Edinburgh
More Information
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Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

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Responsible Party: University of Edinburgh
ClinicalTrials.gov Identifier: NCT02080377     History of Changes
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

Keywords provided by University of Edinburgh:
Pregnancy
Gestational diabetes
Glycaemic control
Metformin

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