A Randomized, Double-Blind, Crossover Trial Comparing the Safety and Efficacy of Insulin Lispro With the Safety and Efficacy of Insulin Aspart in Subjects With Type 2 Diabetes on CSII Therapy
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 入组人数
- 122
- 试验地点
- 1
- 主要终点
- Glycosylated Hemoglobin A1C (HbA1c) at Endpoint
研究概览
简要总结
This study will provide information on the use of insulin lispro and insulin aspart in insulin pumps in participants with type 2 diabetes.
详细描述
This study will provide clinical information on the use of insulin lispro in continuous subcutaneous insulin infusion (CSII) in participants with type 2 diabetes. This study is designed to allow comparison of the 2 rapid-acting insulin analogs, with regard to their efficacy and safety, when used as a pump insulin therapy in this participant population. Each participant will be randomized to 1 of the 2 sequence groups in a 1:1 ratio and randomization will be stratified according to screening A1C (less than or equal to 8.0% or greater than 8.0%) and thiazolidinedione (TZD) use (yes or no). The study design includes the following periods: Screening/Randomization, Treatment Period 1 (16 weeks), and Treatment Period 2 (16 weeks).
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Crossover
- 主要目的
- Treatment
- 盲法
- Triple (Participant, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 85 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Have type 2 diabetes (per World Health Organization [WHO] Classification of Diabetes)
- •Have been treated with CSII therapy using a rapid-acting analog for the previous 6 months
- •Have a screening A1C less than or equal to 9.0% (no lower limit for A1C)
- •Have a body mass index (BMI) less than 45 kilograms/square meter (kg/m²) at screening
- •Have a history of stable body weight (not varying by greater than 10% for at least 3 months prior to screening)
- •For participants on oral anti-diabetes medications (OAMs): must have been on a stable dose of OAMs, labeled for use with insulin, for at least 3 months prior to study entry
排除标准
- •Have severe insulin resistance [require greater than 2 units/kilogram/day (U/kg/day) of insulin]
- •Are taking or have taken within the last 3 months, antihyperglycemic medication not approved for use with insulin, injectable non-insulin antihyperglycemic medications, or have a contraindication to current antihyperglycemic medication
- •Have a serum creatinine greater than or equal to 2 milligrams/deciliter (mg/dL) if not on metformin; known metabolic or lactic acidosis; any condition associated with hypoperfusion, hypoxemia, dehydration, or sepsis; and/or a radiologic contrast study within 48 hours prior to study entry
- •Are receiving chronic (lasting longer than 2 weeks) systemic glucocorticoid therapy (excluding topical, intraocular, intraarticular, and inhaled preparations) or have received such therapy within 2 weeks immediately before screening
- •Have had more than 1 episode of hypoglycemia (defined as requiring assistance of a third party due to disabling hypoglycemia) within 6 months prior to entry into the study
研究组 & 干预措施
Insulin Lispro, then Insulin Aspart
Insulin lispro [100 units/milliliter (U/mL)] administered by continuous subcutaneous insulin infusion (CSII) pump for 16 weeks in Treatment Period 1, followed by insulin aspart (100 U/mL) administered by CSII pump for 16 weeks in Treatment Period 2.
干预措施: Insulin Lispro (Drug)
Insulin Aspart, then Insulin Lispro
Insulin aspart (100 U/mL) administered by CSII pump for 16 weeks in Treatment Period 1, followed by insulin lispro (100 U/mL) administered by CSII pump for 16 weeks in Treatment Period 2.
干预措施: Insulin Aspart (Drug)
结局指标
主要结局
Glycosylated Hemoglobin A1C (HbA1c) at Endpoint
时间窗: After 16 weeks of each treatment (Periods1 and 2)
Hemoglobin A1c (HbA1c) is a form of hemoglobin which is measured primarily to identify the average plasma glucose concentration over the last 8-12 weeks. Least Squares (LS) means were adjusted for treatment, period, sequence, thiazolidinedione use (Yes/No), baseline HbA1c (\>8% or ≤8%) and participants.
次要结局
- Total Daily Insulin Dose(Week 16 of each treatment (Periods 1 and 2))
- Rate of Hypoglycemic Events Per 30 Days(Baseline through 16 weeks of each treatment (Periods 1 and 2))
- Change From Baseline in Weight(Baseline, Week 16 of treatment Periods 1 and 2)
- Percentage of Participants With Hypoglycemic Events(Baseline through 16 weeks of each treatment (Periods 1 and 2))