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

This study is not yet open for participant recruitment. (see Contacts and Locations)
Verified January 2014 by University of Edinburgh
Sponsor:
Collaborator:
Chief Scientist Office of the Scottish Government
Information provided by (Responsible Party):
University of Edinburgh
ClinicalTrials.gov Identifier:
NCT02080377
First received: February 11, 2014
Last updated: March 4, 2014
Last verified: January 2014
  Purpose

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.


Condition Intervention Phase
Pregnancy
Gestational Diabetes
Drug: Glibenclamide
Drug: Insulin
Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: A Feasibility Study Looking at the Use of Glibenclamide and metfoRmin Versus stAndard Care in gEstational diabeteS

Resource links provided by NLM:


Further study details as provided by University of Edinburgh:

Primary Outcome Measures:
  • Number of women willing to be randomised [ Time Frame: 2 years ] [ Designated as safety issue: No ]
    • Retention - proportion of women randomised who remain in the study to provide outcomes
    • Adherence - proportion of clinicians who adhere to the treatment regimen(s)


Secondary Outcome Measures:
  • Glycaemic control [ Time Frame: 2 weekly ] [ Designated as safety issue: Yes ]
    Safety - number of hypoglycaemic episodes needing treatment, any other adverse events

  • Patient satisfaction [ Time Frame: 36-38 weeks gestation ] [ Designated as safety issue: No ]
    assessed by visual analogue scale

  • Clinical outcomes [ Time Frame: 36 weeks ] [ Designated as safety issue: No ]
    Change in maternal weight between booking and 36 weeks

  • Clinical outcome [ Time Frame: 40 weeks ] [ Designated as safety issue: No ]
    Mode and gestation of delivery.

  • Clinical Outcome [ Time Frame: 40 weeks ] [ Designated as safety issue: No ]
    Birthweight centile (adjusted for sex and gestation at birth)

  • Clinical Outcome [ Time Frame: 2 days ] [ Designated as safety issue: Yes ]
    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)


Estimated Enrollment: 44
Study Start Date: April 2014
Estimated Study Completion Date: January 2016
Estimated Primary Completion Date: October 2015 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: Current Standard Care
Insulin + Metformin
Drug: Insulin
Active Comparator: Treatment
Glibenclamide + Metformin
Drug: Glibenclamide

  Eligibility

Ages Eligible for Study:   16 Years to 50 Years
Genders Eligible for Study:   Female
Accepts Healthy Volunteers:   No
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.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT02080377

Contacts
Contact: Sonia Whyte, MPH 0131 242 2693 sonia.whyte@ed.ac.uk

Locations
United Kingdom
Princess Royal Infirmary Not yet recruiting
Glasgow, Lanarkshire, United Kingdom, G31 2ER
Principal Investigator: Robert Lindsay, MD         
Simpson Centre for Reproductive Health, Royal Infirmary Hospital, Edinburgh Not yet recruiting
Edinburgh, Lothian, United Kingdom, EH16 4SA
Principal Investigator: Jane E Norman, MD         
Western General Hospital Not yet recruiting
Edinburgh, Lothian, United Kingdom, EH4 2XU
Principal Investigator: Mark Strachan, MD         
Sponsors and Collaborators
University of Edinburgh
Chief Scientist Office of the Scottish Government
Investigators
Principal Investigator: Jane E Norman, MD University of Edinburgh
  More Information

No publications provided

Responsible Party: University of Edinburgh
ClinicalTrials.gov Identifier: NCT02080377     History of Changes
Other Study ID Numbers: GRACES, 2013-004706-25
Study First Received: February 11, 2014
Last Updated: March 4, 2014
Health Authority: United Kingdom: Medicines and Healthcare Products Regulatory Agency
United Kingdom: National Health Service
United Kingdom: Research Ethics Committee

Keywords provided by University of Edinburgh:
Pregnancy
Gestational diabetes
Glycaemic control
Metformin

Additional relevant MeSH terms:
Diabetes, Gestational
Diabetes Mellitus
Glucose Metabolism Disorders
Metabolic Diseases
Endocrine System Diseases
Pregnancy Complications
Glyburide
Insulin
Metformin
Hypoglycemic Agents
Physiological Effects of Drugs
Pharmacologic Actions

ClinicalTrials.gov processed this record on August 19, 2014