NCT01159353已完成1 期
A Randomized, Double Blind Study to Assess the Pharmacodynamic and Pharmacokinetic Effects of Insulin Glulisine in Obese Subjects With Type 2 Diabetes After a Standard Meal in Comparison to Insulin Aspart
适应症
干预措施
相关药物
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 发起方
- Sanofi
- 入组人数
- 37
- 试验地点
- 1
- 主要终点
- Area under the plasma glucose concentration curve (AUC) between 0 and 1 hour after insulin injection AUC(0-1h)
研究概览
简要总结
Primary Objective:
- To assess the effect of insulin glulisine on the post-prandial plasma glucose excursion during the first hour after a standard meal in comparison to insulin aspart in obese subjects with type 2 diabetes.
Secondary Objectives:
Pharmacodynamic objectives:
- To assess the effect of insulin glulisine on the postprandial plasma glucose excursion during 6 hours after a standard meal in comparison to insulin aspart.
Pharmacokinetic objective:
- To assess post-prandial plasma insulin excursion after a standard meal, in each treatment groups
Safety objective:
- To assess the safety of insulin glulisine in comparison to insulin aspart
详细描述
Duration of treatment: two study days separated by a 7-day wash-out period
Duration of observation:
- screening period of 1-2 weeks, >2 study days (with a wash-out period of 7 days between the study days),
- Follow-up visit (within 2 weeks after the end of the study treatment period).
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
- Double (Participant, Investigator)
入排标准
- 年龄范围
- 18 Years 至 70 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •patients with type 2 diabetes for at least one year
- •treated with oral antidiabetic agents (OADs) for at least 6 months
- •Baseline C-peptide ≥0.1 nmol/L
- •BMI (body mass index) between 30 and 40 kg/m2
- •HbA1c (glycosylated hemoglobin) < 8.5%
- •signed informed consent
排除标准
- •type I diabetes mellitus
- •current treatment with insulin
- •pregnant and breast-feeding women
- •any medication known to influence insulin sensitivity
- •current treatment with systemic corticosteroids
- •history of acute metabolic complications in the past 3 months
- •recurrent severe hypoglycaemia or hypoglycaemic unawareness
- •active proliferative diabetic retinopathy and known diabetic gastroparesis
- •impaired hepatic function, as shown but not limited to ALT or AST above 2 times the upper limit of normal
- •clinically relevant illness such as nephropathy and impaired renal function as shown by clearance < 30 ml/min
- •any history or presence of clinically relevant abnormality, medical condition (cardiovascular, pulmonary, gastro-intestinal, hepatic, renal, metabolic, hematological, neurologic, psychiatric, systemic, ocular or infectious disease; any acute infectious disease or signs of acute illness making implementation of the protocol or interpretation of the results difficult
- •hypersensitivity to insulins or insulin analogs
- •The above information is not intended to contain all considerations relevant to a patient's potential participation in a clinical trial.
研究组 & 干预措施
insulin glulisine + insulin aspart
Experimental
insulin glulisine (1 day) + wash-out (7 days) + insulin aspart (1 day)
干预措施: Insulin glulisine (Drug)
insulin glulisine + insulin aspart
Experimental
insulin glulisine (1 day) + wash-out (7 days) + insulin aspart (1 day)
干预措施: Insulin aspart (Drug)
insulin aspart + insulin glulisine
Experimental
insulin glulisine (1 day) + wash-out (7 days) + insulin aspart (1 day)
干预措施: Insulin glulisine (Drug)
insulin aspart + insulin glulisine
Experimental
insulin glulisine (1 day) + wash-out (7 days) + insulin aspart (1 day)
干预措施: Insulin aspart (Drug)
结局指标
主要结局
Area under the plasma glucose concentration curve (AUC) between 0 and 1 hour after insulin injection AUC(0-1h)
时间窗: At day 1 of each treatment period
次要结局
- Area under the curve of plasma glucose concentration AUC(0-2h)(At day 1 of each treatment period)
- Area under the curve of plasma glucose concentration AUC(0-4h)(At day 1 of each treatment period)
- Area under the curve of plasma glucose concentration AUC(0-6h)(At day 1 of each treatment period)
- Delta plasma glucose at 1h after standard meal(At day 1 of each treatment period)
- Maximum glucose concentration (GLU max)(At day 1 of each treatment period)
- Maximum glucose excursion (delta GLU max)(At day 1 of each treatment period)
- Time to delta GLU max(At day 1 of each treatment period)
- Time to fraction of total glucose AUC(10%, 20%)(At day 1 of each treatment period)
- Area under the plasma insulin concentration curve AUC (0-1h)(At day 1 of each treatment period)
- Area under the plasma insulin concentration curve AUC (0-2h)(At day 1 of each treatment period)
- Area under the plasma insulin concentration curve AUC (0-4h)(At day 1 of each treatment period)
- Area under the plasma insulin concentration curve AUC (0-6h)(At day 1 of each treatment period)
- Maximum insulin concentration (Cmax)(At day 1 of each treatment period)
- Time to fraction of total insulin AUC (10%, 20%)(At day 1 of each treatment period)
- Time to Cmax(At day 1 of each treatment period)
- Hypoglycaemia and adverse events(from randomization to the end of study)
研究者
研究点 (1)
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