A Randomized Prospective Trial of Metformin Compared to Glyburide in Gestational Diabetes
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 149
- 试验地点
- 1
- 主要终点
- Number of Participants Assessed for Glucose Control
研究概览
简要总结
Our hypothesis is that metformin and glyburide will have equal efficacy in controlling blood glucose in gestational diabetics with no increase in adverse maternal, fetal or neonatal outcomes.
详细描述
Pregnant women are screened with a one hour 50g glucose challenge. Women with values of 130 mg/dl or greater are then given a 100g glucose tolerance test. Two abnormal values are diagnostic of gestational diabetes. all women are initially counseled on diet and exercise. Women who fail to maintain a fasting of <105mg/dl and 2 hr postprandial < 120 mg/dl are offered participation in the study. Women were randomized to either metformin or glyburide via a computer generated randomization. Women who fail to meet glycemic goals after receiving the maximum dose of study medication were considered treatment failures and insulin therapy was initiated.
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
- 13 Years 至 —（Child, Adult, Older Adult）
- 性别
- Female
- 接受健康志愿者
- 是
入选标准
- •Gestational diabetes not controlled with diet and exercise
排除标准
- •history of alcohol misuse
- •history of drug misuse
- •Chronic hypertension requiring medication
- •Renal failure
- •Hepatic disease or dysfunction
- •Known fetal anomaly
- •Inability to give consent
- •known allergy to metformin or glyburide
研究组 & 干预措施
Metformin
干预措施: metformin (Drug)
Glyburide
干预措施: Glyburide (Drug)
结局指标
主要结局
Number of Participants Assessed for Glucose Control
时间窗: fasting and 2 hour postprandial blood glucose
The importance of exercise in the management of blood glucose was emphasized, and 30 minutes of walking per day was recommended. Patients received instruction from a nurse educator or a certified diabetes educator regarding diet and the use of the glucometer. Number of participants with a glucose level \<100 mg/dL.
次要结局
未报告次要终点