NCT01027871已完成2 期
A Phase 2 Study of LY2605541 Compared With Insulin Glargine in the Treatment of Type 2 Diabetes Mellitus
适应症
干预措施
相关药物
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 入组人数
- 289
- 试验地点
- 1
- 主要终点
- Fasting Blood Glucose (FBG) Level at Week 12 Endpoint as Measured by the 8-Point Self-Monitored Blood Glucose (SMBG) Profiles
研究概览
简要总结
Comparison of fasting blood glucose levels in patients with Type 2 diabetes after 12 weeks of treatment with a new basal insulin analog or with insulin glargine.
详细描述
Patients in this study will continue to use their stable prestudy dose of metformin and/or a sulfonylurea. Prestudy therapy also includes once daily insulin glargine or neutral protamine Hagedorn (NPH) insulin. The 12-week active treatment phase will be followed by a 4-week follow-up period, during which patients will return to the basal insulin recommended by the investigator.
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
- •Type 2 diabetes mellitus (T2DM) for at least 1 year
- •At least 18 years of age
- •Using metformin and/or sulfonylurea(s) with once daily glargine or NPH for at least 3 months prior to the study. Prestudy dose requirements: insulin dose maximum 1.0 unit/kilogram/day (U/kg/day). Oral antihyperglycemic medications (OAMs): Metformin dose at least 1500 milligram/day (mg/day) and/or sulfonylurea dose at least half the maximum daily dose specified in the local package insert. OAM doses stable for 6 weeks prior to the study.
- •Hemoglobin A1c (HbA1c) less than or equal to 10.5% before randomization
- •Body Mass Index (BMI) 19 to 45 kilogram/square meter (kg/m²)
- •Capable and willing to prepare and inject insulin with a syringe while continuing to use the prestudy OAMs, monitor own blood glucose; complete the study diary; be receptive to diabetes education; comply with study visits and receive telephone calls between visits
- •Women of childbearing potential must test negative for pregnancy before receiving treatment and agree to use reliable birth control until completing the follow-up visit
排除标准
- •Long-term use of short- or rapid-acting or premixed insulin within the 6 months before the study. Short-term insulin therapy or occasional use are permitted
- •Use of any glucose-lowering medications not allowed by the inclusion criteria in the 3 months before entry into the study
- •Use of prescription or over-the-counter medications to promote weight loss within 3 months before entry into the study
- •Current participation in a weight loss program, or plans to do so during the study
- •Treatment with any antibody-based therapy within 6 months prior to the study
- •Use of chronic (>14 consecutive days) systemic glucocorticoid therapy currently or within 4 weeks prior to the study
- •More than 1 episode of severe hypoglycemia within 6 months prior to the study, or currently diagnosed with hypoglycemia unawareness
- •2 or more emergency room visits or hospitalizations due to poor glucose control in the 6 months preceding the study
- •Liver disease
- •History of renal transplantation, current renal dialysis, or creatinine >2.0 milligram/deciliter (mg/dL) (177 micromole/Liter [μmol]/L)
- •Cardiac disease with a marked impact on physical functioning
- •Clinically significant electrocardiogram (ECG) abnormalities at screening
- •Malignancy other than basal cell or squamous cell skin cancer
- •Fasting triglycerides >500 mg/dL
- •Known diabetic autonomic neuropathy
- •Known hypersensitivity or allergy to study insulin or its excipients
- •Blood transfusion or severe blood loss within 3 months prior to entry into the study or known hemoglobinopathy, hemolytic anemia, or sickle cell anemia, or any other traits of hemoglobin abnormalities known to interfere with the HbA1c methodology
- •Irregular sleep/wake cycle
- •Women who are breastfeeding
研究组 & 干预措施
Insulin glargine
Active Comparator
干预措施: insulin glargine (Drug)
LY2605541 Dosing Algorithm 1
Experimental
Participants took both LY2605541 and their pre-study insulin for first several days
干预措施: LY2605541 (Drug)
LY2605541 Dosing Algorithm 2
Experimental
Participants took only LY2605541 with first dose doubled
干预措施: LY2605541 (Drug)
结局指标
主要结局
Fasting Blood Glucose (FBG) Level at Week 12 Endpoint as Measured by the 8-Point Self-Monitored Blood Glucose (SMBG) Profiles
时间窗: Week 12
8-point SMBG profiles are measured at morning FBG, midday and evening pre-meal blood glucose (BG), 2-hour postprandial BG after each of the 3 main meals, bedtime BG, 0300 hours BG. Least squares (LS) mean of the FBG is from mixed-model repeated measures (MMRM) approach, which includes fixed effects of treatment (LY2605541 algorithm 1 and 2, glargine); dose conversion (pre-interim analysis \[IA\], post-IA); stratification variables (country, baseline daily basal insulin dose group, and baseline hemoglobin A1c \[HbA1c\] group); visit; visit and treatment interaction; random effect for participant.
次要结局
- Change From Baseline in Fasting Blood Glucose (FBG) at Week 12 Endpoint(Baseline, Week 12)
- Change From Baseline in Hemoglobin A1c (HbA1c) at Week 12 Endpoint(Baseline, Week 12)
- Percentage of Participants With HbA1c <7.0% and ≤6.5% at Week 12 Endpoint(Week 12)
- Percentage of Participants With HbA1c <7.0% and HbA1c ≤6.5% at Week 12 Endpoint Who Did Not Experience a Hypoglycemic Episode During Treatment(Week 12)
- 8-Point Self-Monitored Blood Glucose (SMBG) Measures at Week 12 Endpoint(Week 12)
- Daily Basal Insulin Dose at Week 2 and Week 12(Week 2 and Week 12)
- Percentage of Participants With Hypoglycemia From Baseline Through Week 12(Baseline through Week 12)
- Rate of Hypoglycemia Per 30 Days From Baseline Through Week 12(Baseline through Week 12)
- Percentage of Participants With Antibody Status Change From Baseline to Week 12 and Week 16(Week 12 and Week 16)
- Glycemic Variability in Fasting Blood Glucose at Baseline and Week 12(Baseline and Week12)
- Pharmacokinetics - Drug (LY2605541) Concentration at Steady State (Css) at Week 12 Endpoint(Week 12)
- Change From Baseline in Fasting Blood Glucose (FBG) at Week 12 Endpoint - Subgroup Analysis of LY2605541 Dosing Algorithms(Baseline, Week 12)
- Change From Baseline in HbA1c at Week 12 Endpoint - Subgroup Analysis of LY2605541 Dosing Algorithms(Baseline, Week 12)
- Percentage of Participants With HbA1c <7.0% and ≤6.5% at Week 12 Endpoint - Subgroup Analysis of LY2605541 Dosing Algorithms(Week 12)
- Percentage of Participants Who Did Not Experience a Hypoglycemic Episode During Treatment With HbA1c <7.0% and HbA1c ≤6.5% at Week 12 Endpoint - Subgroup Analysis of LY2605541 Dosing Algorithms(Week 12)
- 8-Point Self-Monitored Blood Glucose (SMBG) Measures at Week 12 Endpoint - Subgroup Analysis of LY2605541 Dosing Algorithms(Week 12)
- Daily Basal Insulin Dose at Week 2 and Week 12 - Subgroup Analysis of LY2605541 Dosing Algorithms(Week 2 and Week 12)
- Percentage of Participants With Hypoglycemia From Baseline Through Week 12 - Subgroup Analysis of LY2605541 Dosing Algorithms(Baseline through Week 12)
- Rate of Hypoglycemia Per 30 Days From Baseline Through Week 12 - Subgroup Analysis of LY2605541 Dosing Algorithms(Baseline through Week 12)
- Glycemic Variability in Fasting Blood Glucose at Baseline and Week 12 - Subgroup Analysis of LY2605541 Dosing Algorithms(Baseline and Week 12)
研究者
研究点 (1)
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