The Effect of Treatment With Basal Insulin Peglispro or Insulin Glargine on the Dose Response Effect of Prandial Insulin Lispro in Patients With Type 1 Diabetes Mellitus.
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 入组人数
- 28
- 试验地点
- 1
- 主要终点
- Pharmacodynamics (PD): Plasma Glucose Area Under the Concentration Curve Zero Through 5 Hours (AUC 0-5h), Above Pre Meal Baseline for Insulin Lispro
研究概览
简要总结
This study will look into how a base dose of insulin peglispro and insulin glargine will affect the meal time dose and efficacy of insulin lispro in type 1 diabetics.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Crossover
- 主要目的
- Basic Science
- 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
- •Have a stable (within 0.5 percent (%) from last measure) glycated hemoglobin (HbA1c) <9.0%
- •Have a stable (within 30%) basal insulin dose of 0.2 to 1.0 units per kilogram per day (U/kg/day) and a total daily insulin dose (basal + prandial/bolus) <1.5 units per kilogram (U/kg)
- •Have C-peptide <0.3 nanomoles per liter (nmol/L)
- •Are able and willing to eat the protocol specified standard breakfast and other meals as required
排除标准
- •Have corrected QT interval (QTc) prolongation >500 milliseconds (ms) or have any other abnormality in the 12 lead electrocardiogram (ECG) that, in the opinion of the investigator, increases the risks associated with participating in the study
- •Have an abnormal blood pressure as determined by the investigator
- •Have a history or presence of cardiovascular, respiratory, hepatic, renal, gastrointestinal, endocrine (apart from Type 1 Diabetes Mellitus [T1DM]), hematological, or neurological disorders
- •Have fasting triglycerides (TGs) >400 milligrams per deciliter (mg/dL) (4.52 micromoles per liter [mmol/L])
- •Have used systemic corticosteroids within 4 weeks prior to randomization
- •Currently receive insulin pump or insulin degludec
- •Have poorly controlled diabetes or are known to have poor awareness of hypoglycemia
- •Have history of gastroparesis or gastrointestinal malabsorption
- •Require treatment with any drug other than insulin to treat diabetes
- •Have a previous history of proliferative retinopathy
研究组 & 干预措施
Insulin Glargine (with Insulin Lispro)
Insulin glargine once daily SC injection at bedtime. Insulin lispro given SC prandially or as a bolus as required
干预措施: Insulin Lispro (Drug)
Insulin peglispro (LY2605541, with Insulin Lispro)
Insulin peglispro (LY2605541) once daily subcutaneous (SC) injection at bedtime. Insulin lispro given SC prandially or as bolus as required
干预措施: Insulin Peglispro (Drug)
Insulin peglispro (LY2605541, with Insulin Lispro)
Insulin peglispro (LY2605541) once daily subcutaneous (SC) injection at bedtime. Insulin lispro given SC prandially or as bolus as required
干预措施: Insulin Lispro (Drug)
Insulin Glargine (with Insulin Lispro)
Insulin glargine once daily SC injection at bedtime. Insulin lispro given SC prandially or as a bolus as required
干预措施: Insulin Glargine (Drug)
结局指标
主要结局
Pharmacodynamics (PD): Plasma Glucose Area Under the Concentration Curve Zero Through 5 Hours (AUC 0-5h), Above Pre Meal Baseline for Insulin Lispro
时间窗: Day 30, 31, 32, 33, 34, pre-breakfast and10,20,30,40,50,60,90,120,150,180,210,240,270, 300 minutes (5 hours) post-breakfast
To quantitate the pharmacodynamic (PD) effect of a range of prandial insulin lispro doses after treatment with insulin peglispro (LY2605541) compared to insulin glargine during a meal tolerance test (MTT), with sequenced doses of insulin lispro ranging from 25% to 150% of each participant's normal dose. Data presented as hours times milligrams per deciliter (mg\*h/dL)
次要结局
- Pharmacokinetics (PK): Under the Concentration Curve Zero Through 5 Hours (AUC 0-5h) for Prandial Insulin Lispro(Day 29: Pre-breakfast, and 15, 30, 45, 60, 90, 120, 150,180,210,270, and 300 minutes (5 hours) post-breakfast)
- Appetite and Satiety Ratings, as Measured Using Visual Analog Scale (VAS) on Day 29(Day 29:Upon waking, pre-breakfast, 1 hour (hr), 2 hr, 3 hr, 4 hr and 5 hr post breakfast)
- Pharmacodynamics (PD): Average Glucose Infusion Rate From Euglycemic 2-step Hyperinsulinemic Clamp (M-value)(Day 35, last 60 minutes of euglycemic 2-step hyperinsulinemic clamp)
- Pharmacokinetics (PK): Area Under the Concentration Curve From Time Zero to Last Time (AUC [0 Tlast]) for Paracetamol(Day 29: Pre-breakfast, and 15, 30, 45, 60, 90, 120, 150,180,210,270, and 300 minutes (5 hours) post-breakfast)
- Pharmacodynamics (PD): Area Under the Concentration Zero Through 5 Hours (AUC 0-5h) for Triglycerides(Day 29, predose and 15, 30, 45, 60, 90, 120, 150,180,210,270, and 300 minutes (5 hours) post-breakfast)
- Pharmacokinetics (PK): Area Under the Concentration Curve (AUC) for Insulin Lispro During Clamp(Day 35, insulin clearance during lispro infusion (dosing=infusion))