A Feasibility Study Looking at the Use of Glibenclamide and metfoRmin Versus stAndard Care in gEstational diabeteS

Pregnancy Clinical Trial

— GRACES  

Official title:

A Feasibility Study Looking at the Use of Glibenclamide and metfoRmin Versus stAndard Care in gEstational diabeteS

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02080377
• Other study ID #: GRACES
• Secondary ID: 2013-004706-25
• Status: Completed
• Phase: Phase 3
• First received: February 11, 2014
• Last updated: December 7, 2016
• Start date: July 2014
• Est. completion date: March 2016

Study information

• Verified date: December 2015
• Source: University of Edinburgh
• Contact: n/a
• Is FDA regulated: No
• Health authority: United Kingdom: Medicines and Healthcare Products Regulatory AgencyUnited Kingdom: National Health ServiceUnited Kingdom: Research Ethics Committee
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 23
• Est. completion date: March 2016
• Est. primary completion date: October 2015
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 16 Years to 50 Years

Eligibility

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.

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Diabetes Mellitus
• Diabetes, Gestational
• Gestational Diabetes
• Pregnancy

Intervention

Drug:
• Glibenclamide

• Insulin

Locations

Country	Name	City	State
United Kingdom	Simpson Centre for Reproductive Health, Royal Infirmary Hospital, Edinburgh	Edinburgh	Lothian
United Kingdom	Western General Hospital	Edinburgh	Lothian
United Kingdom	Princess Royal Infirmary	Glasgow	Lanarkshire
United Kingdom	Queen Elizabeth Hospital	Glasgow
United Kingdom	St Johns Hospital	Livingston	West Lothian

Sponsors (2)

Lead Sponsor	Collaborator
University of Edinburgh	Chief Scientist Office of the Scottish Government

Country where clinical trial is conducted

United Kingdom, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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)	2 years	No
Secondary	Glycaemic control	Safety - number of hypoglycaemic episodes needing treatment, any other adverse events	2 weekly	Yes
Secondary	Patient satisfaction	assessed by visual analogue scale	36-38 weeks gestation	No
Secondary	Clinical outcomes	Change in maternal weight between booking and 36 weeks	36 weeks	No
Secondary	Clinical outcome	Mode and gestation of delivery.	40 weeks	No
Secondary	Clinical Outcome	Birthweight centile (adjusted for sex and gestation at birth)	40 weeks	No
Secondary	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)	2 days	Yes