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
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Condition or disease | Intervention/treatment | Phase |
---|---|---|
Gestational Diabetes Type 2 Diabetes Pregnancy | Drug: Insulin versus glucovance (glyburide/metformin) | Not Applicable |
Study Type : | Interventional (Clinical Trial) |
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 |
- Maternal hemoglobin A1C at delivery
- Maternal fructosamine at delivery
- Maternal glucose at delivery
- Mode of delivery
- Infant birth weight
- Infant initial glucose
- Infant complications

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Ages Eligible for Study: | 18 Years to 45 Years (Adult) |
Sexes Eligible for Study: | Female |
Accepts Healthy Volunteers: | No |
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
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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
Contact: Lorrie A Mason, MSN | 423 664-4460 | lorrie@rocob.com |
United States, Tennessee | |
Regional Obstetrical Consultants | Recruiting |
Chattanooga, Tennessee, United States, 37403 |
Principal Investigator: | Joseph H Kipikasa, MD | Regional Obstetrical Consultants; UT Chattanooga OB-GYN Department |
ClinicalTrials.gov Identifier: | NCT00371306 |
Other Study ID Numbers: |
02-078 |
First Posted: | September 4, 2006 Key Record Dates |
Last Update Posted: | April 20, 2007 |
Last Verified: | April 2007 |
Diabetes Pregnancy |
Diabetes, Gestational Diabetes Mellitus Glucose Metabolism Disorders Metabolic Diseases Endocrine System Diseases |
Pregnancy Complications Metformin Glyburide Hypoglycemic Agents Physiological Effects of Drugs |