NCT00377858已完成4 期
Comparison of Two Approaches to Basal-Bolus Insulin Therapy in Patients With Type 2 Diabetes and Inadequate Glycemic Control on Oral Therapy: Comparison of Premixed Insulin Lispro Mid Mixture With Separate Basal and Bolus Insulin Injections
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
- 484
- 试验地点
- 1
- 主要终点
- Hemoglobin A1c (HbA1c) at 36 Week Endpoint
研究概览
简要总结
A study of patients with type 2 diabetes and inadequate glycemic control on two or more oral antihyperglycemic agents comparing adding insulin lispro mid mixture to the oral antihyperglycemic agents to adding insulin glargine to the oral antihyperglycemic agents.
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 80 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Have type 2 diabetes
- •Have been receiving oral antihyperglycemic medications (OAM) without insulin including at least two of the following at maximally tolerated doses, AND meet the minimum dosing criteria shown: Metformin 1500 mg/day, Sulfonylurea 1/2 the maximum daily dose, according to package insert, Thiazolidinedione (TZD) 30 mg/day pioglitazone or 4 mg/day rosiglitazone. The OAMs also must be used in accordance with the product label
- •Have a hemoglobin A1c greater than or equal to 7.5% and less than or equal to 12.0%.
排除标准
- •Are taking a TZD dose greater than what is indicated in combination with insulin according to the TZD label.
- •Are taking any other glucose-lowering agents not mentioned in Inclusion Criterion.
- •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 40 kg/m
- •Have had more than one episode of severe hypoglycemia in the last24 weeks
- •Are pregnant, intend to be pregnant during the course of the study or are breastfeeding
- •Have clinically significant cardiac, renal, hematologic, oncologic, or hepatic disease
研究组 & 干预措施
Insulin Lispro Mid Mixture
Experimental
Insulin lispro mid mixture (MM) up to three times a day (TID)
干预措施: Insulin lispro mid mixture (MM) (Drug)
Insulin Glargine
Active Comparator
Insulin glargine daily with insulin lispro at mealtime (up to 3 injections) as needed.
干预措施: Insulin glargine (Drug)
结局指标
主要结局
Hemoglobin A1c (HbA1c) at 36 Week Endpoint
时间窗: 36 weeks
Level of hemoglobin A1c at endpoint.
次要结局
- Hemoglobin A1c (HbA1c) at Interval Visits(12, 24, and 36 weeks)
- Percentage of Patients Who Achieved Hemoglobin A1c Less Than or Equal to 6.5%, Greater Than 6.5%, Less Than 7%, Greater Than or Equal to 7%, Less Than or Equal to 7%, and Greater Than 7% at Interval Visits and Endpoint(12-24-36 weeks)
- 7-point Self-monitored Blood Glucose Profiles(Baseline, 12-24-36 weeks)
- Glycemic Variability(Baseline, 12-24-36 weeks)
- Number of Patients With at Least One Self-reported Hypoglycemic Episode, Including Nocturnal (and Non-nocturnal) Hypoglycemia(Baseline to 36 Weeks)
- 30-Day Adjusted Rates of Self-Reported Hypoglycemic Episodes (Including Nocturnal and Non-Nocturnal)(Baseline to 36 Weeks)
- Number of Patients With at Least One Severe Hypoglycemia Episode(Baseline to 36 Weeks)
- Endpoint Insulin Dose Per Body Weight; Total, Basal, and Prandial(36 Weeks)
- Endpoint Insulin Dose; Total, Basal, and Prandial(36 Weeks)
- Number of Insulin Injections Per Day(Weeks 12, 24, 30, 36)
- Change From Baseline in Absolute Body Weight at 36 Week Endpoint(Baseline, 36 Weeks)
研究者
研究点 (1)
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