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Comparison of Glucovance to Insulin for Diabetes During Pregnancy

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ClinicalTrials.gov Identifier: NCT00371306
Recruitment Status : Unknown
Verified April 2007 by Regional Obstetrical Consultants.
Recruitment status was:  Recruiting
First Posted : September 4, 2006
Last Update Posted : April 20, 2007
Sponsor:
Information provided by:

Study Description
Brief Summary:
Pregnant women with gestational or Type 2 diabetes who require medication are placed in one of two groups: Insulin injections or Glucovance (oral administration). Blood glucose is checked 5 times per day, and medication adjusted by perinatologist according to glucose levels. The hypothesis is that patients will have similar or improved blood glucose control on an oral agent as compared to control on insulin.

Condition or disease Intervention/treatment
Gestational Diabetes Type 2 Diabetes Pregnancy Drug: Insulin versus glucovance (glyburide/metformin)

Detailed Description:
According to ACOG guidelines, patients between 24 and 28 weeks gestation will be screened with a 1 hour glucose tolerance test (GTT) by their obstetrician. Those with elevated glucose levels will undergo a 3 hour GTT. According to routine OB standards, if the blood glucose is elevated on 2 or more of 4 parameters during this test (> 95 fasting, > 180 at 1 hour, > 155 at 2 hours, >140 at 3 hours), the patient will begin receiving dietary therapy using ADA guidelines. If blood glucose levels remain 20% above a fasting of 90 & post parandial of 120 with diet alone during a period of 1-3 weeks after diagnosis, the patient will be invited to participate in this study. Type 2 diabetics who have been diagnosed prior to pregnancy will also be included. These patients may enroll in the study prior to 24 weeks gestation, entering at the time of referral. Patients who give consent for participation will be randomly assigned to either insulin therapy (the usual standard of care), or to oral Glucovance therapy (the experimental group). Glucovance will be started at 1.25mg/250mg BID. NPH & regular Insulin will be started on a 1unit/kg basis BID. Both groups will receive care according to the current standard for gestational diabetics and pregnant Type 2 diabetics. The perinatologist and diabetes educator will evaluate the blood glucose record and assess the patient’s adherence to the ADA diet weekly and will determine when the insulin or Glucovance needs to be increased. If the patients in the Glucovance group continue to be poorly controlled with 4 tablets/day (5mg/500mg), the therapy will be continued and insulin will be added to the management. Statistical analysis will compare the two groups for myriad factors including vaginal versus operative deliveries, hemoglobin A1C, fructosamine, and glucose at delivery, infant birth weight, infant complications, initial infant blood glucose.

Study Design

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 200 participants
Allocation: Randomized
Intervention Model: Single Group Assignment
Masking: Single
Primary Purpose: Treatment
Official Title: A Comparison of Glucovance (Glyburide and Metformin) to Insulin Therapy for the Treatment of Gestational Diabetes and Adult Onset Diabetes in Pregnancy
Study Start Date : September 2002
Estimated Study Completion Date : September 2008

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U.S. FDA Resources

Arms and Interventions


Outcome Measures

Primary Outcome Measures :
  1. Maternal hemoglobin A1C at delivery
  2. Maternal fructosamine at delivery
  3. Maternal glucose at delivery

Secondary Outcome Measures :
  1. Mode of delivery
  2. Infant birth weight
  3. Infant initial glucose
  4. Infant complications

Eligibility Criteria

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 45 Years   (Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:Gestational diabetes by ACOG definition or Type 2 diabetes in pregnancy Hyperglycemia despite following ADA diet English or Spanish speaking -

Exclusion Criteria:Already requiring Insulin Serum creatinine > 1.3 or creatinine clearance < 75ml/minute Liver disease

Contacts and Locations

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 ClinicalTrials.gov identifier (NCT number): NCT00371306


Contacts
Contact: Lorrie A Mason, MSN 423 664-4460 lorrie@rocob.com

Locations
United States, Tennessee
Regional Obstetrical Consultants Recruiting
Chattanooga, Tennessee, United States, 37403
Sponsors and Collaborators
Regional Obstetrical Consultants
Investigators
Principal Investigator: Joseph H Kipikasa, MD Regional Obstetrical Consultants; UT Chattanooga OB-GYN Department
More Information

ClinicalTrials.gov Identifier: NCT00371306     History of Changes
Other Study ID Numbers: 02-078
First Posted: September 4, 2006    Key Record Dates
Last Update Posted: April 20, 2007
Last Verified: April 2007

Keywords provided by Regional Obstetrical Consultants:
Diabetes
Pregnancy

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