NCT00560417已完成3 期
A Randomized Trial Comparing Insulin Lispro Protamine Suspension With Insulin Glargine in Subjects With Type 2 Diabetes on Oral Antihyperglycemic Medications and Exenatide
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
- 339
- 试验地点
- 1
- 主要终点
- Change From Baseline in Hemoglobin A1C (HbA1c) at Endpoint (Last Observation Carried Forward [LOCF])
研究概览
简要总结
This study will compare insulin lispro protamine suspension (ILPS) and insulin glargine in combination with the patient's oral diabetes medications and exenatide, for their ability to control blood sugar in patients with type 2 diabetes.
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 74 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Must have type 2 diabetes
- •Must be at least 18 years of age and less than 75 years of age
- •Must be taking exenatide 10 micrograms twice a day (BID) for at least 3 months
- •Must be taking one of the following oral diabetes medication regimens for at least 3 months: (1) metformin (2) metformin + sulfonylurea (3) metformin + thiazolidinedione (TZD). Doses must be at or above the following: Metformin--1500 mg/day, Sulfonylurea--1/2 the maximum daily dose according to the product label, TZD--30 mg/day pioglitazone
- •Must have a hemoglobin A1C greater than or equal to 7.0% and less than or equal to 10.0%
排除标准
- •Must not have used insulin on a regular basis during the past 2 years
- •Must not have taken any glucose-lowering medications not included in the inclusion criteria in the past 3 months
- •Must not have had more than one episode of severe hypoglycemia in the past 6 months
- •Must not have clinically significant hematologic, oncologic, renal, cardiac, hepatic, or gastrointestinal disease
- •Must not be pregnant or intend to get pregnant during the course of the study
研究组 & 干预措施
ILPS
Active Comparator
Insulin Lispro Protamine Suspension (ILPS)
干预措施: Insulin Lispro Protamine Suspension (Drug)
Glargine
Active Comparator
Insulin Glargine
干预措施: Insulin Glargine (Drug)
结局指标
主要结局
Change From Baseline in Hemoglobin A1C (HbA1c) at Endpoint (Last Observation Carried Forward [LOCF])
时间窗: Baseline, Endpoint (LOCF) up to 24 weeks
Least squares mean values were controlled for Baseline + Baseline HbA1c Group + Baseline sulfonylurea (SU) Group.
次要结局
- Actual Hemoglobin A1C at 24 Weeks and Endpoint (LOCF)(24 weeks, Endpoint (LOCF) up to 24 weeks)
- Change From Baseline in Hemoglobin A1C at 24 Weeks and Endpoint (LOCF)(Baseline, 24 Weeks, Endpoint (LOCF) up to 24 weeks)
- Percentage of Participants With Hemoglobin A1C Less Than 7.0% and Hemoglobin A1C Less Than or Equal to 6.5%(Weeks 12, 18, 24 and Endpoint (LOCF) up to 24 weeks)
- 7-Point Self-Monitored Blood Glucose (SMBG) Profiles at Baseline and Endpoint (LOCF)(Baseline, Endpoint (LOCF) up to 24 weeks)
- Glycemic Variability at Baseline and Endpoint (LOCF)(Baseline, Endpoint (LOCF) up to 24 weeks)
- Incidence of Self-reported Hypoglycemic Episodes (All, Non-Nocturnal, Nocturnal, and Severe)(Baseline to Endpoint (LOCF) up to 24 weeks)
- Rate of All, Non-Nocturnal, and Nocturnal Self-Reported Hypoglycemic Episodes (Adjusted for One Year)(Baseline to Endpoint (LOCF) up to 24 weeks)
- Actual Body Weight at Baseline and Endpoint (LOCF)(Baseline, Endpoint (LOCF) up to 24 weeks)
- Change From Baseline in Body Weight at Endpoint (LOCF)(Baseline, Endpoint (LOCF) up to 24 weeks)
- Total Daily Insulin Dose at Endpoint (LOCF)(Endpoint (LOCF) up to 24 weeks)
研究者
研究点 (1)
Loading locations...
相似试验
已完成
3 期
Comparison of Two Basal Insulin Therapies for Patients With Type 1 DiabetesDiabetes Mellitus, Type 1NCT00487240Eli Lilly and Company387
已完成
3 期
Safety and Efficacy Study of Insulin Lispro Versus Insulin Aspart in Participants With Type 2 Diabetes on Insulin Pump TherapyType 2 Diabetes MellitusNCT01474538Eli Lilly and Company122
已完成
3 期
A Study of LY900014 Compared to Insulin Lispro in Participants With Type 2 DiabetesType 2 Diabetes MellitusNCT03214380Eli Lilly and Company933
终止
3 期
Hospital Management of Hyperglycemia Study of Insulin Glargine Plus Insulin Lispro Versus Human Regular InsulinHyperglycemiaNCT01136746Eli Lilly and Company16
已完成
3 期
Comparison of Two Basal Insulins for Patients With Type 2 Diabetes (IOOY)Diabetes Mellitus Type 2NCT00494013Eli Lilly and Company442