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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

Page last updated: August 23, 2015

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