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Lack of Recruitment
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A randomized comparison of glyburide to glucovance (metformin -glyburide) in the management of diabetes in pregnancy.
This study will be a randomized open label trial of glyburide compared to glucovance in the management of gestational diabetes. We hypothesize that glucovance will provide improved glycemic control and a lower failure rate with no increase in neonatal adverse outcomes. Sixty-seven patients will be randomized by computer to each arm of the study. Outcomes will be glycemic control, failure rate of the drug to achieve glycemic goals, and neonatal outcomes.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Glyburide | Active Comparator |
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| Glucovance | Active Comparator |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Glyburide | Drug | glyburide 2.5milligrams (mg) at bedtime (qhs) increased as needed to a maximum of 20mg/day usually taken twice a day (BID) |
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| Measure | Description | Time Frame |
|---|---|---|
| efficacy of glyburide compared to glucovance | failure rate of glyburide compared to glucovance in ability to achieve euglycemia | during the index pregnancy |
| Measure | Description | Time Frame |
|---|---|---|
| maternal hypoglycemia | the rate of maternal hypoglycemia associated with each drug | during the index pregnancy |
| neonatal birthweight | infant weight at birth |
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Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Lisa E Moore, MD | Texas Tech Health Sciences Center El Paso | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| TTUHSC El Paso | El Paso | Texas | 79905 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 18161398 | Background | Moore LE, Briery CM, Clokey D, Martin RW, Williford NJ, Bofill JA, Morrison JC. Metformin and insulin in the management of gestational diabetes mellitus: preliminary results of a comparison. J Reprod Med. 2007 Nov;52(11):1011-5. | |
| 20027034 | Result | Moore LE, Clokey D, Rappaport VJ, Curet LB. Metformin compared with glyburide in gestational diabetes: a randomized controlled trial. Obstet Gynecol. 2010 Jan;115(1):55-59. doi: 10.1097/AOG.0b013e3181c52132. |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan | Jun 5, 2018 | Oct 7, 2019 | Prot_SAP_000.pdf |
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| ID | Term |
|---|---|
| D016640 | Diabetes, Gestational |
| D003920 | Diabetes Mellitus |
| ID | Term |
|---|---|
| D011248 | Pregnancy Complications |
| D005261 | Female Urogenital Diseases and Pregnancy Complications |
| D000091642 | Urogenital Diseases |
| D044882 | Glucose Metabolism Disorders |
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| ID | Term |
|---|---|
| D005905 | Glyburide |
| C417231 | Glucovance |
| D008687 | Metformin |
| ID | Term |
|---|---|
| D013453 | Sulfonylurea Compounds |
| D014508 | Urea |
| D000577 | Amides |
| D009930 | Organic Chemicals |
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| Glucovance | Drug | glucovance (2.5/500) 1 taken orally (PO) at bed time (QHS) increased as needed to a maximum dose of (20/2000)/day usually taken twice a day (BID) |
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| at birth |
| neonatal apgar scores | infant 1 minute and 5 minute apgar scores | at birth |
| neonatal admission to the newborn intensive care unit (NICU) | admission to the Newborn intensive care unit (NICU) | at birth or within the first 24 hours after birth |
| neonatal hypoglycemia | failure of the neonate to maintain blood glucose > 60 milligrams/deciliter (mg/dl) | up to 24 hours after delivery |
| D008659 | Metabolic Diseases |
| D009750 | Nutritional and Metabolic Diseases |
| D004700 | Endocrine System Diseases |
| D013450 |
| Sulfones |
| D013457 | Sulfur Compounds |
| D001645 | Biguanides |
| D006146 | Guanidines |
| D000578 | Amidines |