Non-inferiority Trial Comparing Insulin Glulisine to Insulin Lispro as Part of a Basal-bolus Insulin Regimen for the Treatment of Gestational Diabetes.
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 入组人数
- 17
- 试验地点
- 1
- 主要终点
- show that insulin glulisine is non-inferior to insulin lispro in a basal/bolus regimen to treat hyperglycemia in patient with gestational diabetes mellitus
研究概览
简要总结
We hypothesize that insulin glulisine is non-inferior to currently proven rapid-acting insulin lispro when used in a basal/bolus regimen to treat hyperglycemia in patients with gestational diabetes mellitus.
详细描述
To date, only two rapid-acting insulin analogs have been shown to be safe and effective for the treatment of diabetes during pregnancy: insulin aspart and insulin lispro.
The pharmacokinetics and pharmacodynamics of insulin glulisine are unique and insulin glulisine may be the best rapid-acting analog for the treatment of post-prandial hyperglycemia. We believe that insulin glulisine should be evaluated in women with gestational diabetes for its potential efficacy.
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
- •Informed Consent to participate in clinical trial
- •Pregnant and 20-30 weeks gestation
- •Diagnosed with gestational diabetes
- •Failed diet therapy (failed lifestyle modification will be defined as 10% or greater SMBG values above pre-meal <90mg/dL and post prandial < 120mg/dL
- •Eat at least 2 meals per day
排除标准
- •Pregnant women <18 years old
- •Blood pressure > 140/80 mmHg
- •A1C equal to or greater than 6.5% at time of enrollment
- •Pre-pregnancy BMI > 40Kg/m squared
- •Evidence of any fetal anomaly on any fetal ultrasound
- •Currently using hypoglycemic agent
- •Refusal to use insulin before meals
- •Inability to understand instructions or to consent to participate
- •Pregnant women with history of T1DM or T2DM
- •Clinical judgment by investigator that patient is inappropriate for clinical trial or has a metabolic disorder that could interfere with results
研究组 & 干预措施
NPH and insulin lispro
Patients diagnosed with diabetes during pregnancy will be randomized to long acting insulin NPH and short acting insulin lispro in a basal bolus regimen to treat post prandial hyperglycemia using a dosing schedule of 50% NPH calculated by the patients weight and gestational age and 50% lispro pending their last three SMPG average.
干预措施: NPH (Drug)
NPH and insulin lispro
Patients diagnosed with diabetes during pregnancy will be randomized to long acting insulin NPH and short acting insulin lispro in a basal bolus regimen to treat post prandial hyperglycemia using a dosing schedule of 50% NPH calculated by the patients weight and gestational age and 50% lispro pending their last three SMPG average.
干预措施: Insulin LISPRO (Drug)
NPH and insulin glulisine
Patients with a diagnosis of diabetes during pregnancy will be randomized to using long acting insulin NPH and short acting insulin glulisine as treatment for post prandial hyperglycemia with a 50% NPH dosing schedule based on the weight and gestational age and 50% glulisine schedule based on their last three SMBG result average.
干预措施: NPH (Drug)
NPH and insulin glulisine
Patients with a diagnosis of diabetes during pregnancy will be randomized to using long acting insulin NPH and short acting insulin glulisine as treatment for post prandial hyperglycemia with a 50% NPH dosing schedule based on the weight and gestational age and 50% glulisine schedule based on their last three SMBG result average.
干预措施: Insulin glulisine (Drug)
结局指标
主要结局
show that insulin glulisine is non-inferior to insulin lispro in a basal/bolus regimen to treat hyperglycemia in patient with gestational diabetes mellitus
时间窗: week 4 of insulin treatment
compare average 1-hour post prandial SMBG measurements between patients randomized to insulin glulisine or insulin lispro
次要结局
- Serum blood glucose area under the curve (AUC) at one 4-hour in-clinic meal challenge(week 2 of insulin treatment)
- Compare A1C at enrollment and weekly until delivery(up to 36 weeks)
- Compare incidence of hypoglycemic episodes <60 mg/dL with symptoms(up to 36 weeks)