NCT00494013已完成3 期
Treat-to-Target Comparison of Two Basal Insulin Analogs (Insulin Lispro Protamine Suspension and Comparator) in Basal Therapy for Patients With Type 2 Diabetes Mellitus
适应症
干预措施
相关药物
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 入组人数
- 442
- 试验地点
- 1
- 主要终点
- Change From Baseline to 24 Week Endpoint in Hemoglobin A1c (HbA1c)
研究概览
简要总结
The purpose of this study is to examine the effectiveness and safety of insulin lispro protamine suspension (ILPS) as compared to insulin detemir as basal insulin therapy in adults with type 2 diabetes. A gatekeeper strategy will be employed for sequentially testing the secondary objectives.
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
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Have type 2 diabetes mellitus for at least 1 year.
- •Are at least 18 years old.
- •Have been receiving oral antihyperglycemic medications (OAMs), without insulin, for at least 3 months immediately prior to the study and have been on stable doses of at least 2 of the following OAMs for the 6 weeks prior to Visit 1, at or above the doses defined in the following: Metformin--1500 milligrams per day (mg/day); Sulfonylureas--1/2 the maximum daily dose, according to the local package insert; Dipeptidyl peptidase-intravenous (DPP-IV) inhibitors-- 1/2 the maximum daily dose, according to the local package insert; Thiazolidinediones (TZDs)--30 mg/day pioglitazone or 4 mg/day rosiglitazone.
- •Have a hemoglobin A1c (HbA1c) greater than or equal to 7.5% and less than or equal to 10.0%, as measured by a central laboratory before Visit
- •Body mass index (BMI) greater than or equal to 25 and less than or equal to 45 kilograms per square meter (kg/m2).
- •Exclusion Criteria
- •Have used insulin therapy (outside of pregnancy) any time in the past 2 years, except for short-term treatment of acute conditions, and up to a maximum of 4 weeks.
- •Have taken any glucose-lowering medications not included in Inclusion Criterion [3] (for example, acarbose, miglitol, pramlintide, exenatide, repaglinide, or nateglinide) in the past 3 months before Visit
- •Have had more than 1 episode of severe hypoglycemia, within 6 months prior to entry into the study, or is currently diagnosed as having hypoglycemia unawareness.
- •Have a history of renal transplantation or are currently receiving renal dialysis or creatinine greater than or equal to 2.0 milligrams per deciliter (mg/dL) (177 micromoles per liter [micromol/L]).
- •Have obvious clinical signs or symptoms, or laboratory evidence, of liver disease (alanine transaminase [ALT], or aspartate transaminase [AST] greater than 2 times the upper limit of the reference range, as defined by the local laboratory) or have albumin value above or below the normal reference range, as defined by the local laboratory.
排除标准
- 未提供
研究组 & 干预措施
Detemir
Active Comparator
Detemir: Patient specific dose administered subcutaneously once or twice daily x 24 weeks.
干预措施: Detemir (Drug)
Insulin Lispro Protamine Suspension
Experimental
Insulin Lispro Protamine Suspension: Patient specific dose administered subcutaneously once daily or twice daily x 24 weeks.
干预措施: Insulin Lispro Protamine Suspension (Drug)
结局指标
主要结局
Change From Baseline to 24 Week Endpoint in Hemoglobin A1c (HbA1c)
时间窗: Baseline, 24 Weeks
次要结局
- Actual and Change From Baseline Hemoglobin A1c (HbA1c) Value at 12 Weeks and at 24 Weeks(Baseline, 12 Weeks, 24 Weeks)
- 7-point Self-monitored Blood Glucose (SMBG) Profile at Endpoint(24 Weeks)
- Change in Absolute Body Weight (kg) From Baseline to 24 Week Endpoint(Baseline, 24 Weeks)
- Percentage of Patients With HbA1c <7.0% and HbA1c < or = 6.5% at Endpoint(24 Weeks)
- Glycemic Variability(24 Weeks)
- Number of Participants With Self-reported Hypoglycemic Episodes (Including All, Nocturnal, and Severe Hypoglycemia) Overall for All Study Periods(Baseline to 24 Weeks)
- 1-Year Adjusted Rates of Self-Reported Hypoglycemic Episodes (Including All, Nocturnal, and Severe) Overall(Baseline to 24 Weeks)
- 30-Day Adjusted Rates of Self-Reported Hypoglycemic Episodes (Including All, Nocturnal, and Severe) Overall(Baseline to 24 Weeks)
- Total Daily Insulin Dose (Units) at Endpoint(24 Weeks)
- Total Daily Insulin Dose Per Body Weight (Units/Kilograms) at Endpoint(24 Weeks)
- Number of Injections of Basal Insulin Analog at Endpoint(24 Weeks)
研究者
研究点 (1)
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