Medical Optimization of Management of Type 2 Diabetes Complicating Pregnancy
试验速览
- 阶段
- 3 期
- 状态
- 终止
- 入组人数
- 831
- 试验地点
- 10
- 主要终点
- Number of Participants With Composite Adverse Neonatal Outcome
研究概览
简要总结
Purpose: The objective of this proposal is to study the safety and efficacy of metformin added to insulin for treatment of type 2 diabetes mellitus (T2DM) among pregnant women.
Participants: 950 pregnant women with type 2 diabetes complicating pregnancy from 10 U.S. clinical centers
Procedures (methods): Pregnant women with T2DM between 10 weeks and 22 weeks 6 days and a singleton fetus will be randomized to double-blinded insulin/placebo versus insulin/metformin. Primary outcome is composite adverse neonatal outcome (clinically relevant hypoglycemia, birth trauma, hyperbilirubinemia, stillbirth/neonatal death). Study visits monthly at clinical visits; blood draw at 24-30 weeks, newborn anthropometric measurements at less than 72 hours of life. Maternal and infant outcomes will be chart abstracted.
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
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 45 Years（Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •Maternal age 18-45 years
- •Singleton pregnancy with no known fetal anomalies
- •Gestational age between 10weeks 0 days and 22 weeks 6 days by menstrual dating confirmed by ultrasound, or ultrasound alone
- •Clinical diagnosis of preexisting T2DM requiring medical treatment (oral agent or insulin)
- •Clinical diagnosis of diabetes diagnosed between 10 weeks and < 20 weeks 6 days gestation
- •Willing to start insulin therapy and discontinue oral hypoglycemic pills other than study pills
- •Able to swallow pills
排除标准
- •Clinical diagnosis of pre-existing renal disease, defined as creatinine > 1.5 mg/dL
- •Clinical history of lactic acidosis
- •Known allergy to metformin
- •Participation in another study that could affect primary outcome
- •Delivery planned at non-MOMPOD study locations
- •Unwillingness to use insulin treatment or follow prenatal care doctor's instructions for insulin and blood glucose monitoring
研究组 & 干预措施
Treatment
Metformin 1000 mg twice a day
干预措施: Metformin (Drug)
Placebo
Placebo, identical to Metformin
干预措施: Placebo (Drug)
结局指标
主要结局
Number of Participants With Composite Adverse Neonatal Outcome
时间窗: An average of 48 hours for term infants and 30 days for preterm infants
Participants with one or more of the following: * capillary blood glucose level of \< 30 mg/dL or capillary blood glucose requiring medical treatment, or * Birth trauma (umbilical cord artery pH \< 7.0 or shoulder dystocia with brachial plexus injury), or * Hyperbilirubinemia requiring phototherapy, or * Deliver \< 37 weeks' gestation, or * Miscarry, are stillborn, experience a neonatal demise, or * Large for gestational age infant (birth weight \> 90th percentile for gestational age), or * Small for gestational age infant (birth weight \< 10th percentile for gestational age) or low birth weight (\< 2500 gm)
次要结局
- Mean Infant Fat Mass(Within 72 hrs of birth)
- Neonatal Safety Based on Treatment Emergent Adverse Events(up to 28 days of life)
- Number of Participants With Maternal Side Effects(Throughout study until delivery at 40 weeks gestation)
- Maternal Safety Based on Treatment Emergent Adverse Events(An average of 48 hours following delivery)