NCT01538511已完成1 期
A Two-centre, Randomised, Open-labelled, Four-week, Parallel-group Pharmacokinetics Trial in Japanese Type 2 Diabetic Subjects Characterising the Insulin Profile of Thrice Daily Regimen With Biphasic Insulin Aspart 70 (NN2000-Mix70) With Reference to That of Twice Daily Regimen With Biphasic Insulin Aspart 30 (NN-X14Mix30) and Physiological Insulin Profile in Japanese Healthy Volunteers
适应症
干预措施
相关药物
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 入组人数
- 59
- 试验地点
- 1
- 主要终点
- Area under the plasma insulin concentration curve from 0 to 24 hours
研究概览
简要总结
This trial is conducted in Japan. The aim of this trial is to compare biphasic insulin aspart 70 (NN2000-Mix70) in subjects with type 2 diabetes with that of biphasic insulin aspart 30 (NN-X14Mix30) in healthy volunteers.
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
- 20 Years 至 70 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •SUBJECTS WITH TYPE 2 DIABETES
- •Subjects with type 2 diabetes mellitus
- •Current treatment using intermediate-acting, long-acting or pre-mixed/biphasic insulin preparation (including insulin analogues) in once or twice daily (before breakfast and dinner) treatment regimen for at least 12 weeks (a temporary use [maximum of one week in total] of rapid-acting human insulin will be allowed)
- •Age between 20-69 years, both inclusive
- •HbA1c (glycosylated haemoglobin A1c) below 9.0%
- •Body Mass Index (BMI) 18.5-25.0 kg/m^2
- •Total daily insulin dose (per day) above 0.2 U or IU/kg body weight and below 1.0 U or IU/kg body weight HEALTHY VOLUNTEERS
- •Japanese subjects with considered generally healthy based on medical history and physical examination
- •Age between 20-29 years, both inclusive
- •Body Mass Index (BMI) 18.5-25.0 kg/m^2
- •Subjects with normal glucose tolerance (NGT); defined as fasting plasma glucose below 110 mg/dL and 2-hour post OGTT (oral glucose tolerance test) plasma glucose below 140 mg/dL
排除标准
- •SUBJECTS WITH TYPE 2 DIABETES
- •Proliferative retinopathy or maculopathy requiring acute treatment
- •Impaired hepatic function
- •Impaired renal function
- •Serious cardiac diseases
- •Uncontrolled hypertension
- •Known hypoglycaemia unawareness or recurrent major hypoglycaemia
- •Current treatment or expected at the screening to start treatment with systemic corticosteroids HEALTHY VOLUNTEERS
- •Any clinical laboratory values deviated from the reference range at the laboratory (except for cases within physiological change) at the screening
- •History or presence of diabetes, cancer or any clinically significant cardiac, respiratory, metabolic, renal, hepatic, gastrointestinal, endocrinological, dermatological, venereal, haematological, neurological, or psychiatric diseases or disorders
- •Subjects with a first-degree relative with diabetes mellitus
研究组 & 干预措施
BIAsp 30
Experimental
干预措施: biphasic insulin aspart 30 (Drug)
BIAsp 70
Experimental
干预措施: biphasic insulin aspart 70 (Drug)
结局指标
主要结局
Area under the plasma insulin concentration curve from 0 to 24 hours
次要结局
- Area under the concentration curve of plasma insulin from 0 to 4 hours after meals
- Maximum plasma insulin concentration observed from 0 to 4 hours after meals
- Time to reach the maximum plasma insulin concentration from 0 to 4 hours after meals
- The 24-hour plasma insulin profile deviances in Japanese type 2 diabetic subjects
- Pre-meal plasma glucose concentration before meals
- Postprandial plasma glucose (PPPG) excursion from 0 to 4 hours after meals
- The maximum plasma glucose concentration observed from 0 to 4 hours after meals
- Frequency of adverse events
- The time to reach the maximum plasma glucose concentration of observed from 0 to 4 hours after meals
- Average of plasma glucose concentration from 0 to 24 hours
- The area under the plasma C-peptide concentration curve from 0 to 24 hours derived from the 24-hour plasma C-peptide profile
- Frequency of hypoglycaemic episodes
研究者
研究点 (1)
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