Glyburide vs Glucovance in the Treatment of Gestational Diabetes
试验速览
- 阶段
- 早期 1 期
- 状态
- 终止
- 发起方
- 入组人数
- 7
- 试验地点
- 1
- 主要终点
- efficacy of glyburide compared to glucovance
研究概览
简要总结
A randomized comparison of glyburide to glucovance (metformin -glyburide) in the management of diabetes in pregnancy.
详细描述
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •Gestational diabetes
- •Pregnancy > 12 weeks gestation
- •Ability to give consent
排除标准
- •Inability to consent to the study
- •Pre-existing diabetes
- •Glucose-6-phosphate dehydrogenase (G6PD) deficiency
- •Serum creatinine >1
- •Liver disease
- •Allergy to sulfa;
- •Allergy to glyburide;
- •Allergy to metformin;
- •Fetal anomalies
研究组 & 干预措施
Glyburide
- Patients will check and record blood glucose fasting and 1 hour after each meal each day. Patients will also keep a diary of all meals.
- The starting dose of glyburide may be 2.5milligrams (mg) to 5mg every day(QD) or twice daily (BID) depending on the degree of hyperglycemia.
- The dose of glyburide will be increased as needed to a maximum of 20mg /day.
- Antenatal testing will be initiated at 28 weeks
- Patients will receive monthly growth scans
干预措施: Glyburide (Drug)
Glucovance
- Patients will check and record blood glucose fasting and 1 hour after each meal each day. Patients will also keep a diary of all meals.
- The starting dose of glucovance may be 1.25/250milligrams (mg) either once daily (QD) or twice a day (BID) increased to a maximum of 20mg/2000mg as needed.
- Patients will receive monthly growth scans
- Antenatal testing will be initiated at 28 weeks.
干预措施: Glucovance (Drug)
结局指标
主要结局
efficacy of glyburide compared to glucovance
时间窗: during the index pregnancy
failure rate of glyburide compared to glucovance in ability to achieve euglycemia
次要结局
- maternal hypoglycemia(during the index pregnancy)
- neonatal birthweight(at birth)
- neonatal apgar scores(at birth)
- neonatal admission to the newborn intensive care unit (NICU)(at birth or within the first 24 hours after birth)
- neonatal hypoglycemia(up to 24 hours after delivery)