drugset / Trial / NCT01215331

Gestational Diabetes: Insulin or Oral Hypoglycemic Agents?

NCT01215331

RandomizedParallel-groupOpen-labelTreatment

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.

Timeline

Start
2010-08
Primary completion
2014-04
Completion
2016-05

Drugs

EvaluationDrugModalityDoseRoute
Subject Glyburide Small molecule 10 mg Oral
Comparator Insulin Protein / enzyme biologic 4 iu
Comparator Insulin Protein / enzyme biologic 6 iu
Subject Metformin Small molecule 750 mg Oral

Indications