Glyburide and Metformin for Gestational Diabetes Mellitus
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 发起方
- 入组人数
- 177
- 试验地点
- 8
- 主要终点
- Study drug dosage in pregnancy
研究概览
简要总结
This is a pharmacokinetic and pharmacodynamic study evaluating glyburide, metformin, and combination treatment for gestational diabetes mellitus.
详细描述
Gestational diabetes mellitus (GDM) is a common complication of pregnancy. Multiple treatment regimens are currently used for the management of GDM. Following failure of diet therapy, insulin, glyburide and metformin are all used in the treatment of GDM with the oral medications providing comparable outcomes with insulin but easier route of administration and schedule. The proposed work will evaluate the pharmacokinetics (PK) and pharmacodynamics (PD) of glyburide and metformin alone and in combination in order to lay the foundation in establishing dosage and response information that could be utilized in designing a phase III randomized trial that will ultimately evaluate GDM treatment optimization.
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 45 Years（Adult）
- 性别
- Female
- 接受健康志愿者
- 是
入选标准
- •Gestational Diabetes Subject Selection
- •Pregnant women (singleton pregnancy)
- •Gestational diabetes mellitus
- •Able to give written informed consent
- •Drug treatment is required for GDM
- •Gestational age 20-32 weeks
- •Gestational diabetes diagnosis must occur after 20 weeks and prior to 32 weeks gestation
- •Randomization and treatment initiation must occur no later than 32 weeks gestation
- •Willing to avoid ethanol
- •18-45 years of age
- •Type 2 Diabetes Mellitus Subject Selection
- •Able to give written informed consent
- •New diagnosis of type 2 diabetes mellitus
- •Plan to receive metformin for treatment of type 2 diabetes mellitus
- •18-45 years of age
- •Negative pregnancy test
- •Hemoglobin A1C > 7%
- •Healthy Pregnant Women
- •Able to give written informed consent
- •Pregnant women (singleton)
- •Normal 1-hour glucose tolerance test
- •20-32 weeks gestation
- •18-45 years of age
- •Neonates: All the infants of the pregnant women participating in this study will be included
排除标准
- •Women with GDM and T2DM
- •Women taking medications expected to interact with glyburide, metformin or alter blood glucose concentrations
- •Serum creatinine > 1.2 mg/dL
- •Hematocrit < 28%
- •Allergy to glyburide, metformin or sulfa
- •Significant hepatic disease
- •Congestive heart failure or history of MI
- •Moderate to severe pulmonary disease
- •Adrenal or pituitary insufficiency
- •Healthy Pregnant Women
- •Receiving any hypoglycemic agents
- •Receiving corticosteroids
- •Known kidney, liver, heart, pulmonary, adrenal or pituitary disease
- •Hematocrit < 28%
- •Infants that are not viable or too ill for blood sample collection will be included for clinical outcomes data collection, but will be excluded from other research activities.
- •Infants < 1.5 kg will be included for clinical outcomes data collection, but will be excluded from blood sample collection.
研究组 & 干预措施
GDM Subjects
Women with GDM requiring treatment
干预措施: Metformin (Drug)
GDM Subjects
Women with GDM requiring treatment
干预措施: Glyburide (Drug)
GDM Subjects
Women with GDM requiring treatment
干预措施: Glyburide-Metformin combination (Drug)
结局指标
主要结局
Study drug dosage in pregnancy
时间窗: Completion of data collection (4-5mnths on average in GDM and healthy pregnant women and max of 6 months in newly diagnosed T2DMs)
(1) Determination of metformin dosage in pregnancy needed to produce comparable concentrations to the approved dosage range in non-pregnant women. (2)To compare metformin apparent oral clearance in pregnant and non-pregnant women. (3)To evaluate the effect of GLY monotherapy, MET monotherapy, and GLY-MET combination on insulin sensitivity, beta-cell responsivity index and disposition index (response vectors) describing the mechanism and magnitude of effect.
次要结局
- Determine GLY and MET PK parameters(Conclusion of data collection (up to 6 months))