Gestational Diabetes: Insulin or Oral Hypoglycemic Agents?
- Conditions
- Gestational Diabetes Mellitus
- Interventions
- Drug: Metformin, glyburide and insulin
- Registration Number
- NCT01215331
- Lead Sponsor
- Université de Sherbrooke
- 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.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- Female
- Target Recruitment
- 73
- 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.
- 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.
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Oral Hypoglycemic Agents Metformin, glyburide and insulin Metformin + glyburide + insulin if needed Insulin Insulin Rapid acting insulin and long acting insulin
- Primary Outcome Measures
Name Time Method Glycemic control 36 and 37th week of gestation Mean of the capillary glycemic control at 36 and 37th week of gestation.
- Secondary Outcome Measures
Name Time Method Acceptability of the treatment 8-12 weeks after delivery
Trial Locations
- Locations (1)
Centre de recherche clinique du CHUS
🇨🇦Sherbrooke, Quebec, Canada