Comparison of the Insulin Therapies: Insulin Lispro Low Mix (25%) and Insulin Glargine in Patients With Diabetes Mellitus Type 2
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 入组人数
- 53
- 试验地点
- 1
- 主要终点
- Change from baseline to endpoint in 2h postprandial blood glucose excursion after breakfast
研究概览
简要总结
In patients with type 2 diabetes who have not been on insulin therapy before the study will achieve better glycemic control by the treatment regiment consisting of two times daily insulin lispro mix 25 than by the treatment regiment with consisting of one time daily injection of insulin glargine. Improved glycemic control will be compared by the fasting plasma glucose and blood glucose excursions 2 hours after breakfast.
详细描述
The objective of this study is to investigate which type of insulin regimen is the best way to achieve best glycemic control in early type 2 diabetes. Patients with diabetes mellitus type 2 with a duration of diabetes between 1 and 10 years without previous insulin therapy will be randomized on insulin lispro mix 25 or insulin glargine therapy. Glycemic control will be compared by the between treatment difference in fasting plasma glucose and 2h postprandial blood glucose excursions (preprandial -postprandial excursions) after breakfast.
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
- 30 Years 至 75 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Males or females who have type 2 diabetes between 1 and 10 years
- •Have used diet and/or maximum doses of oral antidiabetic agents (combination) for the treatment of their diabetes
- •Have not been on insulin treatment within 3 months before entry into the study
- •Have a hemoglobin A1c in the range of 8.0 to 12.5% according to a local laboratory within 4 weeks prior to or at Visit 1
- •Have a body mass index below 40 kg/m²
排除标准
- •Receive chronic (lasting longer than 2 weeks) systemic glucocorticoid therapy (excluding topical and inhaled preparations) or have received such therapy within 2 weeks immediately prior to Visit 1
- •Have a known allergy to insulin
- •Have serum creatinine greater than or equal to 1.5 mg/dl as determined by a local laboratory
- •Have known proliferative retinopathy
- •Have had more than one unexplained episode of severe hypoglycemia (defined as requiring assistance of another person due to disabling hypoglycemia) within 6 months prior to entering the study
研究组 & 干预措施
2
Insulin glargine given SC once-daily in conjunction with oral antidiabetic medications.
干预措施: Glargine (Drug)
1
Lispro mix 25 SC twice-daily in conjunction with oral antidiabetic medications.
干预措施: Insulin lispro mix 25 (Drug)
结局指标
主要结局
Change from baseline to endpoint in 2h postprandial blood glucose excursion after breakfast
时间窗: 16 weeks or end of study.
次要结局
- Hemoglobin A1c measured at endpoint(16 weeks or end of study.)
- Change of hemoglobin A1c from baseline to endpoint(16 weeks or end of study.)
- Glycemic control as determined by self-monitored blood glucose concentrations(16 weeks or end of study.)
- The incidence and rate of self-reported hypoglycemic episodes(16 weeks or end of study.)
- Body mass index (BMI)(16 weeks or end of study.)
- Body weight(16 weeks or end of study.)
- Total Insulin Doses(16 weeks or end of study.)