Gestational Diabetes: Insulin or Oral Hypoglycemic Agents? (DG5)

This study is ongoing, but not recruiting participants.
Sponsor:
Collaborator:
Fonds de la Recherche en Santé du Québec
Information provided by (Responsible Party):
Jean-Luc Ardilouze, Université de Sherbrooke
ClinicalTrials.gov Identifier:
NCT01215331
First received: October 5, 2010
Last updated: April 3, 2014
Last verified: April 2014
  Purpose

Gestational diabetes mellitus takes place in 2 steps. First, it is the consequence of insulin resistance due to the modifications of the pregnancy hormonal environment, and second, of the deficiency of the beta cells of the pancreas to respond by a sufficient insulin secretion. This physiopathology is closely connected to the one of type 2 diabetes. Insulin, indeed, can remedy these 2 etiologies, but it is logical to think about using oral hypoglycemic agents which have been created to treat them: they are a natural choice because they improve insulin sensitivity (metformin, a biguanide) or insulin secretion (glyburide, a sulfonylurea). It also seems natural to use them in combination, glyburide being added to metformin if needed.

OUR GENERAL RESEARCH HYPOTHESIS IS THAT: in pregnant women with gestational diabetes mellitus, using both oral hypoglycemic agents (glyburide added to metformin if needed) allows a glycemic control comparable to the one obtained with insulin, but with a better acceptability from women and a better health status, diabetes treatment satisfaction and well-being and a reduced postnatal depression.


Condition Intervention Phase
Gestational Diabetes Mellitus
Drug: Insulin
Drug: Metformin, glyburide and insulin
Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Gestational Diabetes Mellitus: Insulin or Oral Hypoglycemic Agents?

Resource links provided by NLM:


Further study details as provided by Université de Sherbrooke:

Primary Outcome Measures:
  • Glycemic control [ Time Frame: 36 and 37th week of gestation ] [ Designated as safety issue: Yes ]
    Mean of the capillary glycemic control at 36 and 37th week of gestation.


Secondary Outcome Measures:
  • Acceptability of the treatment [ Time Frame: 8-12 weeks after delivery ] [ Designated as safety issue: No ]

Estimated Enrollment: 275
Study Start Date: August 2010
Estimated Study Completion Date: April 2015
Estimated Primary Completion Date: April 2014 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: Insulin
Rapid acting insulin and long acting insulin
Drug: Insulin
Insulins most commonly used during pregnancy by our group are rapid acting insulins and long acting human insulins (long acting analogs are not authorized in pregnancy). An ultra-fast acting insulin will be started before a meal (1, 2 or 3 meals) at 4-6 IU (according to the weight) if the glycemic value 2 hours after this meal is ≥ 6.7 mmol/L in 50% of cases. It will be increased by 2 units every 2 days until obtaining the aimed objectives. Long acting insulin will be started at 4-6 units at bedtime if the glycemic value before breakfast is ≥ 5.3 mmol/L in 50% of cases, and it will be increased by 2 units every 2 days until reaching the objective. A combination of both insulins could be necessary (maximum of 4 injections per day).
Experimental: Oral Hypoglycemic Agents
Metformin + glyburide + insulin if needed
Drug: Metformin, glyburide and insulin

Metformin (tablets of 500 mg) will be started at 250 mg/day x 1 day, and increased thereafter by 250 mg per day every 3 days until obtaining an adequate glycemic control. If metformin does not prove its effect at a dose of 750 mg, or if the side effects (mainly gastric) command to slow down or not to increase the posology, glyburide will be added.

Glyburide (tablets of 5 mg) will be started at a dose of 2.5 mg and will be increased by 2.5 mg every 3 days until obtaining an adequate glycemic control. The maximal dose in the study will bw 10 mg. It corresponds to the half of the maximal dose recommended in Canada.

Treatment failure is defined as glycemia above the Canadian Diabetes Association therapeutic objectives in spite of maximal doses or whether the doses can not be increased because of side effects. Insulin will be added to oral hypoglycemic agents.


  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Female
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • women,
  • age ≥ 18 yrs,
  • with gestational diabetes at 24-28 weeks (Canadian Diabetes Association (CDA) criteria),
  • who need a pharmacological treatment following the failure of the diet and exercise,
  • to understand and read French or English.

Exclusion Criteria:

  • known type 1 or type 2 diabetes,
  • treatment interfering with glucose metabolism,
  • allergies to one of the components of the treatment,
  • hepatic or hematologic diseases.
  Contacts and Locations
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Please refer to this study by its ClinicalTrials.gov identifier: NCT01215331

Locations
Canada, Quebec
Centre de recherche clinique du CHUS
Sherbrooke, Quebec, Canada, J1H 5N4
Sponsors and Collaborators
Université de Sherbrooke
Fonds de la Recherche en Santé du Québec
Investigators
Principal Investigator: Jean-Luc Ardilouze, MD, PhD Universite de Sherbrooke
  More Information

No publications provided

Responsible Party: Jean-Luc Ardilouze, Endocrinologist, researcher, Université de Sherbrooke
ClinicalTrials.gov Identifier: NCT01215331     History of Changes
Other Study ID Numbers: 08-057
Study First Received: October 5, 2010
Last Updated: April 3, 2014
Health Authority: Canada: Ethics Review Committee
Canada: Health Canada

Keywords provided by Université de Sherbrooke:
Gestational Diabetes Mellitus
Treatment
Insulin
Metformin
Glyburide

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

ClinicalTrials.gov processed this record on August 19, 2014