Pilot Study of Metformin vs. Insulin in Pregnant Overt Diabetics (MIPOD)
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 入组人数
- 31
- 试验地点
- 1
- 主要终点
- Blood Glucose Measurements
研究概览
简要总结
Many women come into pregnancy with diabetes that is controlled with either Metformin or diet control; however, the current standard of care for the treatment of preexisting diabetes in pregnancy is insulin. Metformin is widely used in the non-pregnant population for glycemic control, and has been used in pregnancy for other indications without adverse maternal or fetal outcomes. What remains unproven is the ability of Metformin to adequately control glucose in women during pregnancy.
Our goal is to randomize 100 women who enter pregnancy with diabetes that is controlled by either diet or an oral agent and women who are found to have an abnormal glucose challenge test at less than 20 weeks to either standard treatment with weight based Regular and neutral protamine Hagedorn (NPH) insulin or Metformin. Our hypothesis is that Metformin will provide glycemic control that is equivalent to insulin in these women.
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
- •Receiving prenatal care at University of North Carolina (UNC), Chapel Hill Obstetric clinics and planning delivery at UNC Women's Hospital
- •Diagnosis of Diabetes prior to pregnancy with use of an oral hypoglycemic agent or dietary control
- •Diagnosis of early gestational diabetes prior to 20 weeks gestation via abnormal 3 hour glucose challenge testing using the national diabetes data group (NDDG)criteria
- •Less than 24 weeks at study enrollment
- •Singleton or twin pregnancy
- •English or Spanish speaking
- •Able to give informed consent
排除标准
- •End organ complications of diabetes (retinopathy, renal insufficiency, etc.)
- •Prior need for insulin for glycemic control
- •History of diabetic ketoacidosis (DKA) or hyperosmolar state
- •Prior adverse reaction (ie. lactic acidosis) or allergy to Metformin
- •Kidney or liver disease
- •Significant medical co-morbidities (lupus, cystic fibrosis, etc.) Hypertension controlled on one medication, well controlled asthma, and well controlled thyroid disease are not excluded.
研究组 & 干预措施
Metformin
Women who enter pregnancy with a diagnosis of non insulin dependent/Type 2 Diabetes that is controlled with diet or an oral hypoglycemic agent, and women who demonstrate abnormal glucose tolerance prior to 20 weeks of gestation by abnormal 3 hour glucose challenge testing will be offered study participation. After informed consent, they will be randomized 1:1 to either the Metformin or Insulin group.
干预措施: Metformin (Drug)
Insulin
Women who enter pregnancy with a diagnosis of non insulin dependent/Type 2 Diabetes that is controlled with diet or an oral hypoglycemic agent, and women who demonstrate abnormal glucose tolerance prior to 20 weeks of gestation by abnormal 3 hour glucose challenge testing will be offered study participation. After informed consent, they will be randomized 1:1 to either the Metformin or Insulin group.
干预措施: Insulin (Drug)
结局指标
主要结局
Blood Glucose Measurements
时间窗: Daily fasting and 1-hr post prandial measures were taken from time of enrollment until delivery
Patients self monitored glucose measures throughout pregnancy to aid glycemic control. Fasting morning measures and postprandial measures were taken at 1 hour after breakfast, lunch, and dinner.
次要结局
- Percent of Glucose Values at or Below Fasting Goal (<95 mg/dL)(Baseline throughout pregnancy until time of delivery)
- Number of Babies With Adverse Neonatal Outcomes(Delivery until hospital discharge)
- Number of Patients With Obstetric Complications(Throughout pregnancy until hospital discharge following delivery.)
- Maternal Weight Gain(Baseline throughout pregnancy until last prenatal visit.)
- Number of Babies With Neonatal Hypoglycemia(Time of delivery through hospital discharge)
- Glycosylated Hemoglobin (HbA1c) by Pregnancy Trimester(1st, 2nd, and 3rd trimester)
- Percent of Glucose Values at or Below Postprandial Goal (<130 mg/dL)(Baseline throughout pregnancy until time of delivery)
- Number of Episodes Maternal Hypoglycemia(Baseline throughout pregnancy until time of delivery)