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

NCT02080377 | Completed Phase 3

• 2 other identifiers: GRACES2013-004706-25
• Study Type: interventional
• Target: 23
• Locations: 1 country
• Sites: 5

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.

Conditions

Pregnancy; Gestational Diabetes

Keywords

Pregnancy; Gestational diabetes; Glycaemic control; Metformin

Outcome Measures

Primary Outcomes (1)

• 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

Secondary Outcomes (6)

• Glycaemic control

  2 weekly

• Patient satisfaction

  36-38 weeks gestation

• Clinical outcomes

  36 weeks

• Clinical outcome

  40 weeks

• Clinical Outcome

  40 weeks

Study Arms (2)

Current Standard Care

ACTIVE COMPARATOR

Insulin + Metformin

Drug: Insulin

Treatment

ACTIVE COMPARATOR

Glibenclamide + Metformin

Drug: Glibenclamide

Interventions

Glibenclamide DRUG

Treatment

Insulin DRUG

Current Standard Care

Eligibility Criteria

• Age: 16 Years - 50 Years
• Sex: female
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• University of Edinburgh: lead
• Chief Scientist Office of the Scottish Government: collaborator

Study Sites (5)

Queen Elizabeth Hospital

Glasgow, Glasgow, United Kingdom

Location

Princess Royal Infirmary

Glasgow, Lanarkshire, G31 2ER, United Kingdom

Location

Simpson Centre for Reproductive Health, Royal Infirmary Hospital, Edinburgh

Edinburgh, Lothian, EH16 4SA, United Kingdom

Location

Western General Hospital

Edinburgh, Lothian, EH4 2XU, United Kingdom

Location

St Johns Hospital

Livingston, West Lothian, United Kingdom

Location

Related Publications (1)

• 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.

  PMID: 28938877 DERIVED

MeSH Terms

Conditions

Diabetes, Gestational

Interventions

Glyburide; Insulin

Condition Hierarchy (Ancestors)

Pregnancy Complications; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Diabetes Mellitus; Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases; Endocrine System Diseases

Intervention Hierarchy (Ancestors)

Sulfonylurea Compounds; Urea; Amides; Organic Chemicals; Sulfones; Sulfur Compounds; Proinsulin; Insulins; Pancreatic Hormones; Peptide Hormones; Hormones; Hormones, Hormone Substitutes, and Hormone Antagonists; Peptides; Amino Acids, Peptides, and Proteins

Study Officials

• Jane E Norman, MD

  University of Edinburgh

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: February 11, 2014
• First Posted: March 6, 2014
• Study Start: July 1, 2014
• Primary Completion: October 1, 2015
• Study Completion: March 1, 2016
• Last Updated: December 8, 2016

Record last verified: 2015-12

Locations

GB (5)