Metformin Versus Insulin in Gestational Diabetes. A Randomized Controlled Single Center Trial.
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 入组人数
- 221
- 主要终点
- Birth Weight Per Arm
研究概览
简要总结
Gestational diabetes is traditionally treated with insulin. Metformin is a peroral drug used worldwide in the treatment of type 2 diabetes and also in a few studies on patients with gestational diabetes. The investigators aim is to compare insulin and metformin in the treatment of gestational diabetes. The investigators hypothesis is that there is no difference between insulin and metformin treated mothers in the main outcome criteria (birth weight, neonatal complications).
详细描述
Gestational diabetes is traditionally treated with insulin. Metformin is a peroral drug used worldwide in the treatment of type 2 diabetes and also in a few studies on patients with gestational diabetes. The investigators aim is to compare insulin and metformin in the treatment of gestational diabetes. The investigators hypothesis is that there is no difference between insulin and metformin treated mothers in the main outcome criteria (birth weight, neonatal complications). The study was performed as a randomized controlled trial in one center, Turku University hospital using the non-inferiority design in June 2006 - December 2010. The final study population consisted of altogether 217 women, of whom 110 received metformin and 107 insulin.
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
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •Mothers with gestational diabetes who had at least twice plasma glucose at fasting > 5.4 mmol/L and/or 1 hour postprandial value > 7.7 mmol/L at 24 to 32 gestational weeks
排除标准
- •Fasting glucose > 7.0 mmol/L or 1 hour postprandial plasma glucose > 11.0 mmol/L or Glycosylated hemoglobin A1c (HbA1c) > 7.0%
- •Renal, hepatic or cardiac failure
- •Pregestational use of metformin
- •Pregnancy with multiple fetuses
研究组 & 干预措施
Metformin
Metformin 500 mg 1-2 tablets twice daily according to plasma glucose values
干预措施: metformin (Drug)
insulin
NPH insulin once or twice daily and/or insulin lispro or aspart according to preprandial and postprandial glucose values
干预措施: insulin (Drug)
结局指标
主要结局
Birth Weight Per Arm
时间窗: delivery
birth weight adjusted for gestational weeks expressed as standard deviation units using data from Finnish fetal growth charts in normal pregnancies
次要结局
- Pregnancy Induced Hypertension Per Arm(up to on the average 40 weeks of gestation)
- Maternal Weight Gain Per Arm(up to on the average 40 weeks of gestation)
- Pre-eclampsia Per Arm(up to on the average 40 weeks of gestation)
- Mode of Delivery Per Arm(delivery)
- Gestational Weeks at Delivery Per Arm(delivery)
- Induction of Delivery Per Arm(delivery)
- Shoulder Dystocia Per Arm(delivery)
- Neonatal Hypoglycemia Per Arm(0-24 h after delivery)
- Neonatal Hyperbilirubinemia Per Arm(0-3 days after delivery)
- Apgar Score at 5 Min After Delivery Per Arm(5 minutes after delivery)
- Neonate Transfer to Intensive Care Unit Per Arm(0-5 days after delivery)
- Child Outcome at 2 Years Per Arm(2 years after birth)
研究者
Tapani Rönnemaa
professor
Turku University Hospital