Gestational Diabetes: Insulin or Oral Hypoglycemic Agents?
Information source: Université de Sherbrooke
ClinicalTrials.gov processed this data on August 23, 2015 Link to the current ClinicalTrials.gov record.
Condition(s) targeted: Gestational Diabetes Mellitus
Intervention: Insulin (Drug); Metformin, glyburide and insulin (Drug)
Phase: Phase 3
Status: Active, not recruiting
Sponsored by: Université de Sherbrooke Official(s) and/or principal investigator(s): Jean-Luc Ardilouze, MD, PhD, Principal Investigator, Affiliation: Universite de Sherbrooke
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.
Clinical Details
Official title: Gestational Diabetes Mellitus: Insulin or Oral Hypoglycemic Agents?
Study design: Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment
Primary outcome: Glycemic control
Secondary outcome: Acceptability of the treatment
Eligibility
Minimum age: 18 Years.
Maximum age: N/A.
Gender(s): Female.
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.
Locations and Contacts
Centre de recherche clinique du CHUS, Sherbrooke, Quebec J1H 5N4, Canada
Additional Information
Starting date: August 2010
Last updated: June 16, 2015
|