NCT00548808已完成4 期
Comparison of Insulin Lispro Low Mixture With Insulin Glargine When Initiating and Intensifying Insulin Therapy As Required in Patients With Type 2 Diabetes Who Have Inadequate Glycemic Control on Oral Antihyperglycemic Medication
适应症
干预措施
相关药物
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 入组人数
- 426
- 试验地点
- 1
- 主要终点
- Change From Baseline to 48 Week Endpoint in Hemoglobin A1c (HbA1c)
研究概览
简要总结
The purpose of the study is to compare the insulin lispro low mixture (1, 2 or 3 daily injections) with insulin glargine (alone or with 1, 2 or 3 insulin lispro daily injections) on lowering the blood sugar level
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 79 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Type 2 diabetes mellitus
- •Receiving oral antihyperglycemic medications (including metformin) without insulin injection in the last 90 days
- •Hemoglobin A1c (HbA1c) equal to or greater than 7.0% but less than 11.0%
- •Willing to receive insulin injection while continuing to take the prestudy oral antihyperglycemic medications
- •Able to perform self monitoring of blood glucose
排除标准
- •Are taking any other glucose-lowering agents other than metformin, sulfonylurea or Thiazolidinedione (Pioglitazone)
- •Have taken acarbose, miglitol, pramlintide, exenatide, repaglinide, or nateglinide in the past 6 weeks, or for a total of 30 days or more, in the last 24 weeks
- •Have a body mass index greater than 35 kg/m2
- •History or presence of kidney disease
- •Have cardiac disease (Class III or IV)
研究组 & 干预措施
Insulin lispro low mixture
Experimental
Insulin lispro low mixture (1, 2 or 3 daily injections)
干预措施: Insulin lispro low mixture (Drug)
Insulin glargine
Active Comparator
Insulin glargine (alone or with 1, 2 or 3 daily injections of insulin lispro)
干预措施: Insulin glargine (Drug)
Insulin glargine
Active Comparator
Insulin glargine (alone or with 1, 2 or 3 daily injections of insulin lispro)
干预措施: Insulin lispro (Drug)
结局指标
主要结局
Change From Baseline to 48 Week Endpoint in Hemoglobin A1c (HbA1c)
时间窗: Baseline, 48 weeks
次要结局
- Change in Hemoglobin A1c (HbA1c) Over Time(Baseline, 16 Weeks, 32 Weeks, 48 Weeks)
- Percentage of Patients Achieving HbA1c <6.5% and <7% Over Time(16 weeks, 32 weeks, 48 weeks)
- 7-point Self-monitored Blood Glucose Profiles(Baseline, 16 weeks, 32 weeks, 48 weeks)
- Change From Baseline in Postprandial Blood Glucose Over Time(Baseline, 16 weeks, 32 weeks, 48 weeks)
- Daily Total Insulin Dose (U/Day) at 16, 32, and 48 Weeks(16 weeks, 32 weeks, 48 weeks)
- Daily Total Insulin Dose Per Body Weight (U/kg/Day) at 16, 32, and 48 Weeks(16 weeks, 32 weeks, 48 weeks)
- Change From Baseline to 48 Week Endpoint in Lipid and Cholesterol Profiles(baseline, 48 weeks)
- Safety: Number of Participants With Serious and Non-Serious Adverse Events(baseline through 48 weeks)
研究者
研究点 (1)
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