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

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ClinicalTrials.gov Identifier: NCT02080377
Recruitment Status : Completed
First Posted : March 6, 2014
Last Update Posted : December 8, 2016
Sponsor:
Collaborator:
Chief Scientist Office of the Scottish Government
Information provided by (Responsible Party):
University of Edinburgh

Tracking Information
First Submitted Date  ICMJE February 11, 2014
First Posted Date  ICMJE March 6, 2014
Last Update Posted Date December 8, 2016
Study Start Date  ICMJE July 2014
Actual Primary Completion Date October 2015   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: March 4, 2014)
Number of women willing to be randomised [ Time Frame: 2 years ]
  • Retention - proportion of women randomised who remain in the study to provide outcomes
  • Adherence - proportion of clinicians who adhere to the treatment regimen(s)
Original Primary Outcome Measures  ICMJE Same as current
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: March 4, 2014)
  • Glycaemic control [ Time Frame: 2 weekly ]
    Safety - number of hypoglycaemic episodes needing treatment, any other adverse events
  • Patient satisfaction [ Time Frame: 36-38 weeks gestation ]
    assessed by visual analogue scale
  • Clinical outcomes [ Time Frame: 36 weeks ]
    Change in maternal weight between booking and 36 weeks
  • Clinical outcome [ Time Frame: 40 weeks ]
    Mode and gestation of delivery.
  • Clinical Outcome [ Time Frame: 40 weeks ]
    Birthweight centile (adjusted for sex and gestation at birth)
  • Clinical Outcome [ Time Frame: 2 days ]
    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)
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE A Feasibility Study Looking at the Use of Glibenclamide and metfoRmin Versus stAndard Care in gEstational diabeteS
Official Title  ICMJE A Feasibility Study Looking at the Use of Glibenclamide and metfoRmin Versus stAndard Care in gEstational diabeteS
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.

Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 3
Study Design  ICMJE Allocation: Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Condition  ICMJE
  • Pregnancy
  • Gestational Diabetes
Intervention  ICMJE
  • Drug: Glibenclamide
  • Drug: Insulin
Study Arms  ICMJE
  • Active Comparator: Current Standard Care
    Insulin + Metformin
    Intervention: Drug: Insulin
  • Active Comparator: Treatment
    Glibenclamide + Metformin
    Intervention: Drug: Glibenclamide
Publications * 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.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: December 3, 2015)
23
Original Estimated Enrollment  ICMJE
 (submitted: March 4, 2014)
44
Actual Study Completion Date  ICMJE March 2016
Actual Primary Completion Date October 2015   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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.
Sex/Gender  ICMJE
Sexes Eligible for Study: Female
Ages  ICMJE 16 Years to 50 Years   (Child, Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE United Kingdom
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT02080377
Other Study ID Numbers  ICMJE GRACES
2013-004706-25 ( EudraCT Number )
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party University of Edinburgh
Study Sponsor  ICMJE University of Edinburgh
Collaborators  ICMJE Chief Scientist Office of the Scottish Government
Investigators  ICMJE
Principal Investigator: Jane E Norman, MD University of Edinburgh
PRS Account University of Edinburgh
Verification Date December 2015

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP