A Feasibility Study Looking at the Use of Glibenclamide and metfoRmin Versus stAndard Care in gEstational diabeteS
This trial has been completed.
|Conditions||pregnancy, gestational diabetes|
|Sponsor||University of Edinburgh|
|Collaborator||Chief Scientist Office of the Scottish Government|
|Start date||July 2014|
|End date||October 2015|
|Trial size||23 participants|
|Trial identifier||NCT02080377, 2013-004706-25, GRACES|
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.
|United States||No locations recruiting|
|Other Countries||No locations recruiting|
|Glasgow, United Kingdom||Princess Royal Infirmary||completed|
|Edinburgh, United Kingdom||Simpson Centre for Reproductive Health, Royal Infirmary Hospital, Edinburgh||completed|
|Edinburgh, United Kingdom||Western General Hospital||completed|
|Livingston, United Kingdom||St Johns Hospital||completed|
|Glasgow, United Kingdom||Queen Elizabeth Hospital||completed|
|Endpoint classification||safety/efficacy study|
|Intervention model||single group assignment|
Insulin + Metformin
Glibenclamide + Metformin
Number of women willing to be randomised
time frame: 2 years
time frame: 2 weekly
time frame: 36-38 weeks gestation
time frame: 36 weeks
time frame: 40 weeks
time frame: 40 weeks
time frame: 2 days
Female participants from 16 years up to 50 years old.
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.
|Official title||A Feasibility Study Looking at the Use of Glibenclamide and metfoRmin Versus stAndard Care in gEstational diabeteS|
|Principal investigator||Jane E Norman, MD|
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