Gestational Diabetes: Insulin or Oral Hypoglycemic Agents? (DG5)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT01215331
Recruitment Status : Completed
First Posted : October 6, 2010
Last Update Posted : May 3, 2018
Fonds de la Recherche en Santé du Québec
Information provided by (Responsible Party):
Jean-Luc Ardilouze, 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.

Condition or disease Intervention/treatment Phase
Gestational Diabetes Mellitus Drug: Insulin Drug: Metformin, glyburide and insulin Phase 3

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 73 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Gestational Diabetes Mellitus: Insulin or Oral Hypoglycemic Agents?
Study Start Date : August 2010
Actual Primary Completion Date : April 2014
Actual Study Completion Date : May 2016

Resource links provided by the National Library of Medicine

Arm Intervention/treatment
Active Comparator: Insulin
Rapid acting insulin and long acting insulin
Drug: Insulin
Insulins most commonly used during pregnancy by our group are rapid acting insulins and long acting human insulins (long acting analogs are not authorized in pregnancy). An ultra-fast acting insulin will be started before a meal (1, 2 or 3 meals) at 4-6 IU (according to the weight) if the glycemic value 2 hours after this meal is ≥ 6.7 mmol/L in 50% of cases. It will be increased by 2 units every 2 days until obtaining the aimed objectives. Long acting insulin will be started at 4-6 units at bedtime if the glycemic value before breakfast is ≥ 5.3 mmol/L in 50% of cases, and it will be increased by 2 units every 2 days until reaching the objective. A combination of both insulins could be necessary (maximum of 4 injections per day).

Experimental: Oral Hypoglycemic Agents
Metformin + glyburide + insulin if needed
Drug: Metformin, glyburide and insulin

Metformin (tablets of 500 mg) will be started at 250 mg/day x 1 day, and increased thereafter by 250 mg per day every 3 days until obtaining an adequate glycemic control. If metformin does not prove its effect at a dose of 750 mg, or if the side effects (mainly gastric) command to slow down or not to increase the posology, glyburide will be added.

Glyburide (tablets of 5 mg) will be started at a dose of 2.5 mg and will be increased by 2.5 mg every 3 days until obtaining an adequate glycemic control. The maximal dose in the study will bw 10 mg. It corresponds to the half of the maximal dose recommended in Canada.

Treatment failure is defined as glycemia above the Canadian Diabetes Association therapeutic objectives in spite of maximal doses or whether the doses can not be increased because of side effects. Insulin will be added to oral hypoglycemic agents.

Primary Outcome Measures :
  1. Glycemic control [ Time Frame: 36 and 37th week of gestation ]
    Mean of the capillary glycemic control at 36 and 37th week of gestation.

Secondary Outcome Measures :
  1. Acceptability of the treatment [ Time Frame: 8-12 weeks after delivery ]

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   No

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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT01215331

Canada, Quebec
Centre de recherche clinique du CHUS
Sherbrooke, Quebec, Canada, J1H 5N4
Sponsors and Collaborators
Université de Sherbrooke
Fonds de la Recherche en Santé du Québec
Principal Investigator: Jean-Luc Ardilouze, MD, PhD Université de Sherbrooke

Responsible Party: Jean-Luc Ardilouze, Endocrinologist, researcher, Université de Sherbrooke Identifier: NCT01215331     History of Changes
Other Study ID Numbers: 08-057
First Posted: October 6, 2010    Key Record Dates
Last Update Posted: May 3, 2018
Last Verified: May 2018

Keywords provided by Jean-Luc Ardilouze, Université de Sherbrooke:
Gestational Diabetes Mellitus

Additional relevant MeSH terms:
Diabetes Mellitus
Diabetes, Gestational
Glucose Metabolism Disorders
Metabolic Diseases
Endocrine System Diseases
Pregnancy Complications
Insulin, Globin Zinc
Hypoglycemic Agents
Insulin, Short-Acting
Physiological Effects of Drugs