A Prospective, Randomized, Double-Blind Comparison of a Long-Acting Basal Insulin Analog LY2963016 to Lantus in Adult Patients With Type 2 Diabetes Mellitus: The ELEMENT 2 Study
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 入组人数
- 759
- 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 main purpose of this study is to compare the effectiveness and safety of LY2963016 versus Lantus in controlling blood sugar levels in combination with two or more oral diabetes medications.
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
- Triple (Participant, Care Provider, Investigator)
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 based on the disease diagnostic criteria World Health Organization (WHO) classification
- •Have been taking at least 2 types of oral diabetes medications for at least 12 weeks prior to entering the study
- •Have a Hemoglobin A1c value greater than or equal to 7.0 percent and less than or equal to 11.0 percent if insulin naive If previously on Lantus, then Hemoglobin A1c must be less than or equal to 11.0 percent
- •Have a body mass index of less than or equal to 45 kilogram per meter squared (kg/m^2)
排除标准
- •Have significant liver, cardiac or gastrointestinal disease
- •Have active cancer or have had cancer within the past 5 years (with the exception of basal cell carcinoma or carcinoma in situ)
- •Have an excessive resistance to insulin or hypersensitivity to Lantus
- •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 taken any other insulin other than Lantus within the past 30 days
- •Taking any other diabetes medicines that are not allowed in the study or not approved to be taken with insulin
研究组 & 干预措施
LY2963016 + OAMs
LY2963016 titrated based on blood glucose readings, administered subcutaneously, once daily in combination with at least 2 oral antihyperglycemic medications (OAMs) [alpha glucosidase inhibitors (AGI), dipeptidyl peptidases intravenous (DPP-IV), meglitinide (MEG), metformin (MET), sulfonylurea (SU), and thiazolidinedione (TZD)] administered per standard of care for 24 weeks
干预措施: LY2963016 (Drug)
LY2963016 + OAMs
LY2963016 titrated based on blood glucose readings, administered subcutaneously, once daily in combination with at least 2 oral antihyperglycemic medications (OAMs) [alpha glucosidase inhibitors (AGI), dipeptidyl peptidases intravenous (DPP-IV), meglitinide (MEG), metformin (MET), sulfonylurea (SU), and thiazolidinedione (TZD)] administered per standard of care for 24 weeks
干预措施: OAMs (Drug)
Lantus + OAMs
Lantus titrated based on blood glucose readings, administered subcutaneously, once daily in combination with at least 2 OAMs (AGI, DPP-IV, MEG, MET, SU, and TZD) administered per standard of care for 24 weeks
干预措施: Lantus (Drug)
Lantus + OAMs
Lantus titrated based on blood glucose readings, administered subcutaneously, once daily in combination with at least 2 OAMs (AGI, DPP-IV, MEG, MET, SU, and TZD) administered per standard of care for 24 weeks
干预措施: OAMs (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. HbA1c is measured primarily to identify average plasma glucose concentration over prolonged periods of time. Least Squares (LS) mean was determined by analysis of covariance (ANCOVA) and adjusted for Baseline HbA1c, country, sulfonylurea use, time of basal insulin injection and treatment.
次要结局
- Insulin Dose Per Body Weight (U/kg) Per Day(Endpoint (up to 24 weeks))
- Percentage of Participants With HbA1c <7 % and HbA1c ≤6.5%(Baseline and 4 weeks and 8 weeks and 12 weeks and 16 weeks and 20 weeks and 24 weeks and Endpoint (up to 24 weeks))
- Change From Baseline in Insulin Antibody Levels(Baseline and 4 weeks and 12 weeks and Endpoint (24 weeks and up to 24 weeks))
- Change From Baseline in Body Weight(Baseline and 4 weeks (wk) and 8 wk and 12 wk and 16 wk and 20 wk and 24 wk and Endpoint (up to 24 wk))
- Adult Low Blood Sugar Survey (ALBSS)(4 weeks (wk) and 12 wk and Endpoint (up to 24 wk))
- Insulin Dose (Units)(Endpoint (up to 24 weeks))
- Change From Baseline in Hemoglobin A1c (HbA1c)(Baseline and 4 weeks and 8 weeks and 12 weeks and 16 weeks and 20 weeks and 24 weeks)
- 7-Point Self-Monitored Blood Glucose (SMBG) Profiles(Baseline and Endpoint [up to 24 weeks (wk)])
- Glycemic Variability of Fasting Blood Glucose(Baseline and Endpoint (up to 24 weeks))
- Insulin Treatment Satisfaction Questionnaire (ITSQ)(4 weeks (wk) and 12 wk and Endpoint (EP) (up to 24 wk))
- Rate Per 30 Days of Hypoglycemic Events(Baseline, Endpoint (up to 24 weeks))
- Incidence of Hypoglycemic Events(Baseline and Endpoint (up to 24 weeks))