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Clinical Trials/NCT01215331
NCT01215331
Completed
Phase 3

Gestational Diabetes Mellitus: Insulin or Oral Hypoglycemic Agents?

Université de Sherbrooke1 site in 1 country73 target enrollmentAugust 2010

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.

Registry
clinicaltrials.gov
Start Date
August 2010
End Date
May 2016
Last Updated
8 years ago
Study Type
Interventional
Study Design
Parallel
Sex
Female

Investigators

Responsible Party
Principal Investigator
Principal Investigator

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)

Study Sites (1)

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