A Prospective, Randomized, Open-label Comparison of a Long-Acting Basal Insulin Analog LY2963016 to Lantus in Combination With Mealtime Insulin Lispro in Adult Patients With Type 1 Diabetes Mellitus
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 入组人数
- 536
- 试验地点
- 1
- 主要终点
- Change From Baseline up to 24 Weeks in Hemoglobin A1c (HbA1c)
研究概览
简要总结
The purpose of this study is to compare the effectiveness and safety of LY2963016 versus Lantus when taken once daily in combination with insulin lispro before meals three times a day.
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 1 diabetes mellitus based on the disease diagnostic criteria [World Health Organization (WHO) Classification]
- •Have duration of diabetes greater than or equal to one year
- •Have Hemoglobin A1c (HbA1c) less than or equal to 11.0%
- •On basal-bolus insulin therapy for at least 1 year [basal insulin must be once daily (QD) injection of human insulin isophane suspension (NPH), Lantus, or detemir and combined with mealtime injections of human regular insulin, or insulin analog lispro, aspart or glulisine]
- •Have a body mass index (BMI) of less than or equal to 35 kilograms/square meter (kg/m²)
排除标准
- •Have had more than one episode of severe low blood sugar (defined as needing someone else to help because you had very low blood sugar) within the 6 months before entering the study
- •Have had more than one episode of diabetic ketoacidosis or emergency room visits for uncontrolled diabetes leading to hospitalization within the 6 months before entering the study
- •Have known hypersensitivity or allergy to any of the study insulins (insulin glargine or insulin lispro) or to excipients of the study insulins
- •Have significant renal, cardiac, gastrointestinal or liver disease
- •Have active cancer or cancer within the past 5 years
研究组 & 干预措施
LY2963016 + Insulin Lispro
LY2963016 titrated based on blood glucose readings, administered subcutaneously, once daily at the same timing (daytime or evening/bedtime) as participant's prestudy basal insulin injection schedule in combination with premeal insulin lispro. Insulin lispro titrated based on blood glucose readings, administered subcutaneously, three times a day for 52 weeks.
干预措施: LY2963016 (Drug)
LY2963016 + Insulin Lispro
LY2963016 titrated based on blood glucose readings, administered subcutaneously, once daily at the same timing (daytime or evening/bedtime) as participant's prestudy basal insulin injection schedule in combination with premeal insulin lispro. Insulin lispro titrated based on blood glucose readings, administered subcutaneously, three times a day for 52 weeks.
干预措施: Insulin Lispro (Drug)
Lantus + Insulin Lispro
Lantus titrated based on blood glucose readings, administered subcutaneously, once daily at the same timing (daytime or evening/bedtime) as participant's prestudy basal insulin injection schedule in combination with premeal insulin lispro. Insulin lispro titrated based on blood glucose readings, administered subcutaneously, three times a day for 52 weeks.
干预措施: Lantus (Drug)
Lantus + Insulin Lispro
Lantus titrated based on blood glucose readings, administered subcutaneously, once daily at the same timing (daytime or evening/bedtime) as participant's prestudy basal insulin injection schedule in combination with premeal insulin lispro. Insulin lispro titrated based on blood glucose readings, administered subcutaneously, three times a day for 52 weeks.
干预措施: Insulin Lispro (Drug)
结局指标
主要结局
Change From Baseline up to 24 Weeks in Hemoglobin A1c (HbA1c)
时间窗: Baseline, Endpoint (up to 24 weeks)
HbA1c is the glycosylated fraction of hemoglobin A which provides an estimate of a participant's blood sugar control over a 6- to 12-week period. Least Squares (LS) means were calculated by analysis of covariance (ANCOVA) and adjusted for baseline HbA1c, treatment and time of basal insulin injection (daytime, evening/bedtime) and country.
次要结局
- Change From Baseline in Insulin Antibody Levels(Baseline, 6 weeks and 12 weeks and Endpoints (up to 24 weeks and up to 52 weeks))
- Glycemic Variability of Fasting Blood Glucose(Baseline and Endpoints (up to 24 weeks and up 52 weeks))
- Adult Low Blood Sugar Survey (ALBSS)(Baseline and 24 weeks and Endpoint (up to 52 weeks))
- Insulin Dose - Units [Total and by Component [Basal and Bolus (Lispro)])(Endpoints [up to 24 weeks (wk) and up to 52 weeks])
- 7-Point Self-Monitored Blood Glucose (SMBG) Profiles(Baseline and Endpoints [up to 24 weeks (wk) and up to 52 weeks])
- Change From Baseline in Body Weight(Baseline, 6 weeks and 12 weeks and 18 weeks and Endpoints (up to 24 weeks and up to 52 weeks))
- Insulin Treatment Satisfaction Questionnaire (ITSQ)(Baseline and 24 weeks and Endpoint (up to 52 weeks))
- Percentage of Participants With Hemoglobin A1c (HbA1c) <7.0% and HbA1c ≤6.5%(Baseline and 6 weeks and 12 weeks and 24 weeks and 36 weeks and 52 weeks and Endpoints (up to 24 weeks and up to 52 weeks))
- Incidence of Hypoglycemic Events(Baseline through 24 weeks (wk) and 52 weeks)
- Change From Baseline in Hemoglobin A1c (HbA1c)(Baseline, 6 weeks and 12 weeks and 24 weeks and 36 weeks and 52 weeks and Endpoint (up to 52 weeks))
- Insulin Dose Per Body Weight (U/kg) (Total and by Component [Basal and Bolus (Lispro)])(Endpoints [up to 24 weeks (wk) and up to 52 weeks])
- Rate Per 30 Days of Hypoglycemic Events(Baseline through 24 weeks (wk) and 52 weeks)