Gestational Diabetes: Insulin or Oral Hypoglycemic Agents?

NCT01215331 | Completed Phase 3 DMC

• 1 other identifier: 08-057
• Study Type: interventional
• Target: 73
• Locations: 1 country
• Sites: 1

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.

Conditions

Gestational Diabetes Mellitus

Keywords

Gestational Diabetes Mellitus; Treatment; Insulin; Metformin; Glyburide

Outcome Measures

Primary Outcomes (1)

• Glycemic control

  Mean of the capillary glycemic control at 36 and 37th week of gestation.

  36 and 37th week of gestation

Secondary Outcomes (1)

• Acceptability of the treatment

  8-12 weeks after delivery

Study Arms (2)

Insulin

ACTIVE COMPARATOR

Rapid acting insulin and long acting insulin

Drug: Insulin

Oral Hypoglycemic Agents

EXPERIMENTAL

Metformin + glyburide + insulin if needed

Drug: Metformin, glyburide and insulin

Interventions

Insulin DRUG

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).

Insulin

Metformin, glyburide and insulin DRUG

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.

Oral Hypoglycemic Agents

Eligibility Criteria

• Age: 18 Years+
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Université de Sherbrooke: lead
• Fonds de la Recherche en Santé du Québec: collaborator

Study Sites (1)

Centre de recherche clinique du CHUS

Sherbrooke, Quebec, J1H 5N4, Canada

Location

MeSH Terms

Conditions

Diabetes, Gestational; Insulin Resistance

Interventions

Insulin; Metformin; Glyburide

Condition Hierarchy (Ancestors)

Pregnancy Complications; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Diabetes Mellitus; Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases; Endocrine System Diseases; Hyperinsulinism

Intervention Hierarchy (Ancestors)

Proinsulin; Insulins; Pancreatic Hormones; Peptide Hormones; Hormones; Hormones, Hormone Substitutes, and Hormone Antagonists; Peptides; Amino Acids, Peptides, and Proteins; Biguanides; Guanidines; Amidines; Organic Chemicals; Sulfonylurea Compounds; Urea; Amides; Sulfones; Sulfur Compounds

Study Officials

• Jean-Luc Ardilouze, MD, PhD

  Université de Sherbrooke

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Endocrinologist, researcher

Study Record Dates

• First Submitted: October 5, 2010
• First Posted: October 6, 2010
• Study Start: August 1, 2010
• Primary Completion: April 1, 2014
• Study Completion: May 1, 2016
• Last Updated: May 3, 2018

Record last verified: 2018-05

Locations

CA (1)