Gestational Diabetes: Insulin or Oral Hypoglycemic Agents? (DG5)
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Purpose
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 | Intervention | Phase |
|---|---|---|
|
Gestational Diabetes Mellitus |
Drug: Insulin Drug: Metformin, glyburide and insulin |
Phase 3 |
| Study Type: | Interventional |
| Study Design: | Allocation: Randomized Endpoint Classification: Efficacy Study Intervention Model: Parallel Assignment Masking: Open Label Primary Purpose: Treatment |
| Official Title: | Gestational Diabetes Mellitus: Insulin or Oral Hypoglycemic Agents? |
- Glycemic control [ Time Frame: 36 and 37th week of gestation ] [ Designated as safety issue: Yes ]Mean of the capillary glycemic control at 36 and 37th week of gestation.
- Acceptability of the treatment [ Time Frame: 8-12 weeks after delivery ] [ Designated as safety issue: No ]
| Estimated Enrollment: | 275 |
| Study Start Date: | August 2010 |
| Estimated Study Completion Date: | December 2013 |
| Estimated Primary Completion Date: | August 2013 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
|
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. |
Eligibility| Ages Eligible for Study: | 18 Years and older |
| Genders 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.
Contacts and Locations| Contact: Jean-Luc Ardilouze, MD, PhD | 819-346-1110 ext 15241 | Jean-Luc.Ardilouze@USherbrooke.ca |
| Contact: Julie Ménard, PhD | 819-346-1110 ext 13534 | Jumenard.chus@ssss.gouv.qc.ca |
| Canada, Quebec | |
| Centre de recherche clinique du CHUS | Recruiting |
| Sherbrooke, Quebec, Canada, J1H 5N4 | |
| Contact: Jean-Luc Ardilouze, MD, PhD 819-346-1110 ext 15241 Jean-Luc.Ardilouze@USherbrooke.ca | |
| Contact: Julie Ménard, PhD 819-346-1110 ext 13534 jumenard.chus@ssss.gouv.qc.ca | |
| Principal Investigator: Jean-Luc Ardilouze, MD, PhD | |
| Principal Investigator: | Jean-Luc Ardilouze, MD, PhD | Universite de Sherbrooke |
More Information
No publications provided
| Responsible Party: | Jean-Luc Ardilouze, Endocrinologist, researcher, Universitaire de Sherbrooke |
| ClinicalTrials.gov Identifier: | NCT01215331 History of Changes |
| Other Study ID Numbers: | 08-057 |
| Study First Received: | October 5, 2010 |
| Last Updated: | May 14, 2013 |
| Health Authority: | Canada: Ethics Review Committee Canada: Health Canada |
Keywords provided by Universitaire de Sherbrooke:
|
Gestational Diabetes Mellitus Treatment Insulin Metformin Glyburide |
Additional relevant MeSH terms:
|
Diabetes Mellitus Diabetes, Gestational Glucose Metabolism Disorders Metabolic Diseases Endocrine System Diseases Pregnancy Complications Glyburide |
Insulin Hypoglycemic Agents Metformin Insulin, Long-Acting Physiological Effects of Drugs Pharmacologic Actions |
ClinicalTrials.gov processed this record on June 17, 2013