A Phase 2 Study of LY2605541 Compared With Insulin Glargine in the Treatment of Type 1 Diabetes Mellitus
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 入组人数
- 138
- 试验地点
- 1
- 主要终点
- Daily Average Blood Glucose (Avg. BG) at Week 8 Endpoint as Measured by the 8-Point Self-Monitored Blood Glucose (SMBG) Profiles
研究概览
简要总结
Comparison of blood glucose levels in patients with Type 1 diabetes when they take a new basal insulin analog and when they take insulin glargine
详细描述
Prestudy treatment for patients who enter this study will be once daily insulin glargine along with mealtime insulins. Patients will continue to use their mealtime insulins throughout the study. The study will consist of 16 weeks of treatment and 4 weeks of follow-up. The 16 weeks of treatment will consist of two 8-week periods (Periods 1 and 2) during which patients will receive insulin glargine for 8 weeks and LY2605541 for 8 weeks in a random sequence. During the 4-week follow-up period, patients will return to insulin glargine or another basal insulin recommended by the investigator.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Crossover
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 65 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Type 1 diabetes mellitus (T1DM) for at least 1 year and using insulin glargine for at least 6 months with a maximum daily dose of 1 unit per kilogram (U/kg).
- •Hemoglobin A1c (HbA1c) of no greater than 10.5% before randomization
- •Body mass index (BMI) 19 to 45 kilogram per square meter (kg/m²)
- •Capable and willing to prepare and inject insulin with a syringe, monitor own blood glucose, complete the study diary, be receptive to diabetes education, comply with study requirements, and receive telephone calls during treatment
- •Women of childbearing potential must test negative for pregnancy before receiving treatment and agree to use reliable birth control until completing the follow-up
排除标准
- •Twice daily use of insulin glargine within 30 days prior to the study
- •Use of any oral or injectable medication intended for the treatment of diabetes mellitus other than insulins in the 3 months prior to the study
- •Use of an insulin pump
- •More than 1 episode of severe hypoglycemia within 3 months prior to the study, or currently diagnosed as having hypoglycemia unawareness
- •2 or more emergency room visits or hospitalizations due to poor glucose control in the 6 months preceding the study
- •Known hypersensitivity or allergy to any of the study insulins or their excipients
- •Blood transfusion or severe blood loss within 3 months prior to 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
- •Pregnant or intend to become pregnant during the study
- •Women who are breastfeeding
- •Use of prescription or over-the-counter medications to promote weight loss within 3 months prior to the study
- •Current participation in a weight loss program or plans to do so during the study
- •Use of chronic (lasting longer than 14 consecutive days) systemic glucocorticoid therapy currently or within 4 weeks prior to the study
- •Cardiac disease with a marked impact on physical functioning
- •Clinically significant electrocardiogram (ECG) abnormalities at screening
- •Fasting triglycerides greater than 500 milligram per deciliter (mg/dL)
- •Liver disease
- •History of renal transplantation, current renal dialysis, or creatinine greater than 2.0 mg/dL (177 micromole per liter [μmol/L])
- •Malignancy other than basal cell or squamous cell skin cancer, currently or within the last 5 years
- •Treatment with any antibody-based therapy within 6 months prior to the study
研究组 & 干预措施
LY2605541 First, Then Insulin Glargine
Participants received LY2605541 for 8 weeks, followed by insulin glargine for 8 weeks.
干预措施: LY2605541 (Drug)
LY2605541 First, Then Insulin Glargine
Participants received LY2605541 for 8 weeks, followed by insulin glargine for 8 weeks.
干预措施: Insulin glargine (Drug)
Insulin Glargine First, Then LY2605541
Participants received insulin glargine for 8 weeks, followed by LY2605541 for 8 weeks.
干预措施: LY2605541 (Drug)
Insulin Glargine First, Then LY2605541
Participants received insulin glargine for 8 weeks, followed by LY2605541 for 8 weeks.
干预措施: Insulin glargine (Drug)
结局指标
主要结局
Daily Average Blood Glucose (Avg. BG) at Week 8 Endpoint as Measured by the 8-Point Self-Monitored Blood Glucose (SMBG) Profiles
时间窗: Week 8 of each treatment period
It is the Avg. of the 8-point SMBG profiles, BG of morning fasting, midday \& evening pre-meal, 2-hour postprandial after each of the 3 main meals, bedtime, 0300 hours. Least squares (LS) mean of daily Avg. BG is from mixed-model repeated measures (MMRM), which includes fixed effects of treatment (LY2605541, Glargine); Treatment Sequence; treatment period; dose conversion (pre-interim analysis \[IA\], post-IA); stratification variables (country, baseline daily basal insulin dose group, and baseline Hemoglobin \[HbA1c\] group); visit; visit and treatment interaction; a random effect for participant.
次要结局
- Change From Baseline in Daily Average Blood Glucose (Avg. BG) at Week 8 Endpoint as Measured by the 8-Point Self-Monitored Blood Glucose (SMBG) Profiles(Baseline, Week 8 of each treatment period)
- Change From Baseline in Hemoglobin (HbA1c) at Week 8 Endpoint of Period I(Baseline, Week 8 (Period I))
- Percentage of Participants With HbA1c <7.0% and HbA1c ≤6.5% at Week 8 Endpoint of Period I(Week 8 (Period I))
- Percentage of Participants With HbA1c <7.0% and HbA1c ≤6.5% at Week 8 Endpoint Who Did Not Experience a Hypoglycemic Episode During Treatment (Period I)(Week 8 (Period I))
- 8-Point Self-Monitored Blood Glucose (SMBG) Measures at Week 8 Endpoint(Week 8 of each treatment period)
- Daily Basal Insulin Dose at Week 2 and Week 8 Endpoint(Week 2 and Week 8 of each treatment period)
- Pharmacokinetics - Drug (LY2605541) Concentration at Steady State (Css) at Week 8 Endpoint(Week 8 of each treatment period)
- Percentage of Participants With Antibody Status Change From Baseline to Week 8, Week 16 and Week 20(Week 8, Week 16 and Week 20)
- Percentage of Participants With Hypoglycemia Baseline Through Week 8(Baseline through Week 8 of each treatment period)
- Rate of Hypoglycemia Per 30 Days Baseline Through Week 8(Baseline through Week 8 of each treatment period)
- Glycemic Variability in Fasting Blood Glucose (FBG) at Week 8 Endpoint(Week 8 of each treatment period)