A Comparison of Insulin Lispro MM Intensive Mixture Therapy With Progressive Dose-Titration of Insulin Lispro LM or Biphasic Insulin Aspart 30/70
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 入组人数
- 302
- 试验地点
- 1
- 主要终点
- Hemoglobin A1c (HbA1c) at 16 Week Endpoint
研究概览
简要总结
Investigation into patients with type 2 diabetes mellitus not achieving adequate glycemic control while treated with combination of premixed insulin analogue formulations twice daily and metformin will be randomly assigned to follow one of two insulin treatment strategies used in combination with metformin administration. The aim of the trial is to try to achieve optimal metabolic control and explore full therapeutic potential of the strategies, patients in both arms will follow progressive insulin dose titration algorithms for 16 weeks.
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
- •Have type 2 diabetes (World Health Organization [WHO] classification).
- •Are at least 30 years of age and less than 75 years of age.
- •Have been receiving hypoglycemic treatment with premixed insulin analogue (either with insulin lispro LM or biphasic insulin aspart 30/70) administered twice daily in combination with at least 1500 milligrams (mg) of metformin per day for at least 60 days immediately prior to the study.
- •Have a hemoglobin A1c 1.2 to 1.8 times the upper limit of the normal reference range at the local laboratory at Visit 1 or
- •Have at least 6 of 9 of the postprandial blood glucose values recorded in the period between Visit 1 and Visit 2 exceeding 180 milligrams per 100 milliliters (mg/dl) (10.0 millimole per liter [mmol/l]).
- •Have given written informed consent to participate in this study in accordance with local regulations.
排除标准
- •Are taking any other oral anti-diabetic medication (OAM) not mentioned in inclusion criterion.
- •Have a body mass index greater than 40 kilograms per meter squared (kg/m2).
- •Have had more than one episode of severe hypoglycemia within 6 months prior to entry into the study.
- •Have congestive heart failure.
- •Have an irregular sleep/wake cycle (for example, patients who sleep during the day and work during the night).
研究组 & 干预措施
insulin lispro LM + insulin lispro MM
Three times per day subcutaneous injection of insulin lispro mid mixture (MM) with the possibility to change the evening injection of MM to insulin lispro low mixture (LM) if fasting blood glucose target is not achieved.
干预措施: insulin lispro LM (Drug)
insulin lispro LM + insulin lispro MM
Three times per day subcutaneous injection of insulin lispro mid mixture (MM) with the possibility to change the evening injection of MM to insulin lispro low mixture (LM) if fasting blood glucose target is not achieved.
干预措施: insulin lispro MM (Drug)
Insulin Biphasic Aspart 30/70 or Insulin Lispro LM
Twice daily subcutaneous injection of either insulin biphasic aspart 30/70 or insulin lispro low mixture (LM) (continuation of analogue formulation used before study enrollment).
干预措施: Insulin Biphasic Aspart 30/70 (Drug)
Insulin Biphasic Aspart 30/70 or Insulin Lispro LM
Twice daily subcutaneous injection of either insulin biphasic aspart 30/70 or insulin lispro low mixture (LM) (continuation of analogue formulation used before study enrollment).
干预措施: insulin lispro LM (Drug)
结局指标
主要结局
Hemoglobin A1c (HbA1c) at 16 Week Endpoint
时间窗: 16 weeks
次要结局
- Percentage of Patients Achieving Hemoglobin A1c (HbA1c) <7% and HbA1c ≤6.5% at 16 Week Endpoint(16 weeks)
- Change From Baseline in Hemoglobin A1c (HbA1c) at 16 Week Endpoint(Baseline, 16 Weeks)
- 2-hour Postprandial Plasma Glucose Concentrations After the Midday Meal From Self-monitored 7-point Plasma Glucose at 16 Week Endpoint(16 weeks)
- Mean 2-hour Postprandial Blood Glucose Excursions After Midday Meal at 16 Week Endpoint(16 weeks)
- Mean Daily Blood Glucose Values at 16 Week Endpoint(16 weeks)
- Number of Patients With Self-reported Hypoglycemic Episodes(Baseline through 16 weeks)
- 30-Day Adjusted Rate of Hypoglycemic Events(Baseline through 16 weeks)
- Change From Baseline in Weight at 16 Week Endpoint(Baseline, 16 weeks)
- Total Daily Insulin Dose at 4 Weeks and 12 Weeks(4 weeks and 12 weeks)