A Phase 3 interventional study of Glibenclamide and Insulin in Pregnancy and Gestational Diabetes, sponsored by University of Edinburgh. Completed at 5 sites in United Kingdom. Open to female participants aged 16 Years to 50 Years. Per ClinicalTrials.gov, last updated 2016-12-08.
Sponsored by University of Edinburgh · Phase 3, Interventional, and Treatment
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.
842 studies on the registry are indexed under Diabetes, Gestational; 198 are open to participants now.
This study's enrollment of 23 is below the median of 110 across 550 interventional studies indexed under Diabetes, Gestational.
Browse Diabetes, Gestational studies →University of Edinburgh is the lead sponsor of 393 studies on the registry; 64 are open to participants now.
Counted across the registry records on this site, refreshed daily.
Exclusion Criteria:
Insulin + Metformin
Drug: Insulin
Glibenclamide + Metformin
Drug: Glibenclamide
Number of women willing to be randomised
* Retention - proportion of women randomised who remain in the study to provide outcomes * Adherence - proportion of clinicians who adhere to the treatment regimen(s)
Time frame: 2 years
Glycaemic control
Safety - number of hypoglycaemic episodes needing treatment, any other adverse events
Time frame: 2 weekly
Patient satisfaction
assessed by visual analogue scale
Time frame: 36-38 weeks gestation
Clinical outcomes
Change in maternal weight between booking and 36 weeks
Time frame: 36 weeks
Clinical outcome
Mode and gestation of delivery.
Time frame: 40 weeks
Clinical Outcome
Birthweight centile (adjusted for sex and gestation at birth)
Time frame: 40 weeks
Clinical Outcome
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)
Time frame: 2 days
This study is completed, as verified in Dec 2015. You cannot join it, but the record below documents what was studied.
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University of Edinburgh