Pregnancy Clinical Trial
Official title:
A Feasibility Study Looking at the Use of Glibenclamide and metfoRmin Versus stAndard Care in gEstational diabeteS
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.
n/a
Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
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