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Comparison of Glucovance to Insulin for Diabetes During Pregnancy
This study is currently recruiting participants.
Study NCT00371306   Information provided by Regional Obstetrical Consultants
First Received: September 1, 2006   Last Updated: April 19, 2007   History of Changes

September 1, 2006
April 19, 2007
September 2002
 
  • Maternal hemoglobin A1C at delivery
  • Maternal fructosamine at delivery
  • Maternal glucose at delivery
Same as current
Complete list of historical versions of study NCT00371306 on ClinicalTrials.gov Archive Site
  • Mode of delivery
  • Infant birth weight
  • Infant initial glucose
  • Infant complications
Same as current
 
Comparison of Glucovance to Insulin for Diabetes During Pregnancy
A Comparison of Glucovance (Glyburide and Metformin) to Insulin Therapy for the Treatment of Gestational Diabetes and Adult Onset Diabetes in Pregnancy

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.

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.

 
Interventional
Treatment, Randomized, Single Blind, Active Control, Single Group Assignment, Safety/Efficacy Study
  • Gestational Diabetes
  • Type 2 Diabetes
  • Pregnancy
Drug: Insulin versus glucovance (glyburide/metformin)
 
 

*   Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.
 
Recruiting
200
September 2008
 

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

-

Female
18 Years to 45 Years
No
Contact: Lorrie A Mason, MSN 423 664-4460 lorrie@rocob.com
United States
 
NCT00371306
 
02-078
Regional Obstetrical Consultants
 
Principal Investigator: Joseph H Kipikasa, MD Regional Obstetrical Consultants; UT Chattanooga OB-GYN Department
Regional Obstetrical Consultants
April 2007

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP