A Phase 2 Open Label Randomized Controlled Trial Determir Vs Neutral Protamine Hagedorn (NPH) In Pregnant Women: DETERMINE Study
试验速览
- 阶段
- 2 期
- 状态
- 招募中
- 入组人数
- 336
- 试验地点
- 1
- 主要终点
- Neonatal Hypoglycemia
研究概览
简要总结
The purpose of the study is to compare rates of neonatal hypoglycemia with maternal NPH vs determir use.
详细描述
Insulin detemir has been used and is FDA approved for type 1 diabetes in pregnancy women and its safety has been well established. At this point, the only long or intermediate acting medication that is approved for type 2 diabetes or gestational diabetes is insulin NPH. The most serious side effect of insulin detemir is hypoglycemia but the rates of hypoglycemia are lower when comparted to NPH both during pregnancy and outside of pregnancy. Diabetes mellitus (DM) is the most common diagnosis in pregnancy and its incidence is continuing to increase. Recent epidemiologic reports place the risk of pre-gestational diabetes at 1-2% and gestational diabetes (GDM) at 12.5%. Risk factors for type 2 diabetes (T2DM) and GDM include obesity, hypertension, family history of diabetes, polycystic ovarian syndrome, or excessive weight gain in pregnancy. Suboptimal control of DM in pregnancy confers significant morbidity on both the mother and fetus, including increased risk of preeclampsia, preterm delivery, perineal lacerations, cesarean delivery, neonatal hypoglycemia, and NICU admissions.
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
- All
- 接受健康志愿者
- 否
入选标准
- •Inclusion criteria will include pregnant women with pre-existing T2DM and GDM who requiring insulin to manage their blood sugars in pregnancy.
排除标准
- •Multiple Gestation
- •Type 1 Diabetes mellatus
- •Known or suspected hypersensitivity to NPH or insulin detemir
- •Known fetal major malformations
- •Chronic renal or hepatic insufficiency
- •Known to be HIV, Hepatitis B, or Hepatitis C positive
- •Indication for planned premature delivery (placenta accrete, or prior classical cesarean delivery)
- •Insulin dependent before conception
研究组 & 干预措施
Insulin NPH
Patients are to receive insulin NPH as long acting insulin to control blood sugars
干预措施: Insulin NPH (Drug)
Insulin Detemir
Patients are to receive insulin detemir as long acting insulin to control blood sugars
干预措施: Insulin Detemir (Drug)
结局指标
主要结局
Neonatal Hypoglycemia
时间窗: Within the first 24 hours of life
Rate (%) of neonatal hypoglycemia
Prolonged neonatal hypoglycemia
时间窗: Neonatal hypoglycemia after the 1st 24 hours of life but before discharge
Rate (%) of prolonged neonatal hypoglycemia
次要结局
- Macrosomia(At birth)
- Need for supplemental oxygen(1 year)
- Need for dextrose infusion in neonate(1 year)
- Neonatal Gastrin Level(At birth)
- Neonatal C-Peptide Level(At birth)
- Mode of delivery(At delivery)
- Gestational Age at delivery(At delivery)
- Neonatal insulin level(At birth)
- Rates of pregnancy induced hypertension(1 year)
- Fetal anomolies(At birth)
- Neonatal leptin level(At birth)
- Maternal glycemic control(1 year)
- Total daily insulin(1 year)
- Polyhydramnios(At birth)
- Neonatal weight(At birth)
- Rates of respiratory distress syndrome(1 year)
- 5 Minute APGAR(At birth)
研究者
Christina S. Han
Maternal-Fetal Medicine Division Director
University of California, Los Angeles