Clinical trial NCT02080377: A Feasibility Study Looking at the Use of Glibenclamide and metfoRmin Versus stAndard Care in gEstational diabeteS
Official title: A Feasibility Study Looking at the Use of Glibenclamide and metfoRmin Versus stAndard Care in gEstational diabeteS
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Pregnancy
Gestational Diabetes
Keywords: Pregnancy
Gestational diabetes
Glycaemic control
Metformin
Lead sponsor: University of Edinburgh
Sponsor class: OTHER
Collaborators: name: Chief Scientist Office of the Scottish Government
First posted: 2014-03-06
Enrollment: 23
Sex: FEMALE
Minimum age (years): 16
Maximum age (years): 50
Standard ages: CHILD
ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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.


Eligibility 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.

Primary outcomes:
measure: Number of women willing to be randomised
timeFrame: 2 years
Secondary outcomes:
measure: Glycaemic control
timeFrame: 2 weekly
measure: Patient satisfaction
timeFrame: 36-38 weeks gestation
measure: Clinical outcomes
timeFrame: 36 weeks
measure: Clinical outcome
timeFrame: 40 weeks
measure: Clinical Outcome
timeFrame: 40 weeks
measure: Clinical Outcome
timeFrame: 2 days
Other outcomes:
Locations:
city: Glasgow
country: United Kingdom
facility: Princess Royal Infirmary
state: Lanarkshire
city: Edinburgh
country: United Kingdom
facility: Simpson Centre for Reproductive Health, Royal Infirmary Hospital, Edinburgh
state: Lothian
city: Edinburgh
country: United Kingdom
facility: Western General Hospital
state: Lothian
city: Livingston
country: United Kingdom
facility: St Johns Hospital
state: West Lothian
city: Glasgow
country: United Kingdom
facility: Queen Elizabeth Hospital
Study officials:
affiliation: University of Edinburgh
name: Jane E Norman, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.