A Feasibility Study Looking at the Use of Glibenclamide and metfoRmin Versus stAndard Care in gEstational diabeteS
NCT ID: NCT02080377
Last Updated: 2016-12-08
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
PHASE3
23 participants
INTERVENTIONAL
2014-07-31
2016-03-31
Brief Summary
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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.
Detailed Description
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Conditions
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Keywords
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Study Design
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RANDOMIZED
SINGLE_GROUP
TREATMENT
NONE
Study Groups
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Current Standard Care
Insulin + Metformin
Insulin
Treatment
Glibenclamide + Metformin
Glibenclamide
Interventions
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Glibenclamide
Insulin
Eligibility Criteria
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Inclusion Criteria
* Inadequate glycaemic control is defined according to the SIGN 116 guidelines.
Exclusion Criteria
* 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.
16 Years
50 Years
FEMALE
No
Sponsors
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Chief Scientist Office of the Scottish Government
OTHER_GOV
University of Edinburgh
OTHER
Responsible Party
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Principal Investigators
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Jane E Norman, MD
Role: PRINCIPAL_INVESTIGATOR
University of Edinburgh
Locations
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Queen Elizabeth Hospital
Glasgow, Glasgow, United Kingdom
Princess Royal Infirmary
Glasgow, Lanarkshire, United Kingdom
Simpson Centre for Reproductive Health, Royal Infirmary Hospital, Edinburgh
Edinburgh, Lothian, United Kingdom
Western General Hospital
Edinburgh, Lothian, United Kingdom
St Johns Hospital
Livingston, West Lothian, United Kingdom
Countries
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References
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Reynolds RM, Denison FC, Juszczak E, Bell JL, Penneycard J, Strachan MWJ, Lindsay RS, Alexander CI, Love CDB, Whyte S, Mackenzie F, Stenson B, Norman JE. Glibenclamide and metfoRmin versus stAndard care in gEstational diabeteS (GRACES): a feasibility open label randomised trial. BMC Pregnancy Childbirth. 2017 Sep 22;17(1):316. doi: 10.1186/s12884-017-1505-3.
Other Identifiers
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2013-004706-25
Identifier Type: EUDRACT_NUMBER
Identifier Source: secondary_id
GRACES
Identifier Type: -
Identifier Source: org_study_id