NCT00110370已完成4 期
A Comparison of Prandial Insulin Lispro Mixtures Therapy to Glargine Basal-Bolus Therapy With Insulin Lispro on the Overall Glycemic Control of Patients With Type 2 Diabetes Previously Treated With Oral Agents Combined With Insulin Glargine
适应症
相关药物
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 入组人数
- 300
- 试验地点
- 48
- 主要终点
- To test the hypothesis that Lispro Mixtures Therapy regimen in combination with oral antihyperglycemic agents (OADs) is non-inferior
研究概览
简要总结
The purpose of this study is to compare Lispro Mixture Therapy (insulin lispro 50/50 given three times daily with meals) to Glargine Basal-Bolus Therapy (insulin glargine daily with the addition of insulin lispro given three times daily with meals). The study is also comparing two different methods for adjusting the dose of insulin.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 30 Years 至 75 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Must have type 2 diabetes.
- •Must be 30-75 years of age at the time of Visit
- •Must be on insulin glargine and oral antidiabetic medicines for at least 90 days.
- •Must be on at least 30 units of glargine per day at enrollment.
- •Have an A1C between 7.5% and 12.0% at Visit 1.
排除标准
- •Must not have used rapid/short-acting insulin on a regular basis in the last 6 months.
- •Must not have more than one episode of severe hypoglycemia in the last 6 months.
- •Must not have a body mass index (BMI) of greater than 45 (morbid obesity).
- •Must not have congestive heart failure that requires medications.
- •Must not have had a kidney transplant or currently receiving dialysis
结局指标
主要结局
To test the hypothesis that Lispro Mixtures Therapy regimen in combination with oral antihyperglycemic agents (OADs) is non-inferior
(A1C less than 7%) with once-daily insulin glargine in combination with OADs.
in overall glycemic control (lower A1CF) at endpoint compared to to Glargine Basal-Bolus Therapy in combination
with OADs in patients with type 2 diabetes who have clearly failed to achieve glycemic goal
次要结局
- To test in both arms the following: frequency and incidence
- of self-reported hypoglycemia, blood glucose data, 8-point profiles, insulin dose,
- body weight, SAE's and study drug related AEs.
研究者
研究点 (48)
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