Gestational Diabetes Mellitus: Insulin or Oral Hypoglycemic Agents?
Overview
- Phase
- Phase 3
- Intervention
- Insulin
- Conditions
- Gestational Diabetes Mellitus
- Sponsor
- Université de Sherbrooke
- Enrollment
- 73
- Locations
- 1
- Primary Endpoint
- Glycemic control
- Status
- Completed
- Last Updated
- 8 years ago
Overview
Brief Summary
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.
Investigators
Jean-Luc Ardilouze
Endocrinologist, researcher
Université de Sherbrooke
Eligibility Criteria
Inclusion Criteria
- •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.
Arms & Interventions
Insulin
Rapid acting insulin and long acting insulin
Intervention: Insulin
Oral Hypoglycemic Agents
Metformin + glyburide + insulin if needed
Intervention: Metformin, glyburide and insulin
Outcomes
Primary Outcomes
Glycemic control
Time Frame: 36 and 37th week of gestation
Mean of the capillary glycemic control at 36 and 37th week of gestation.
Secondary Outcomes
- Acceptability of the treatment(8-12 weeks after delivery)