A Comparison of Pharmacodynamics and Pharmacokinetics of Insulin Aspart, Biphasic Insulin Aspart 70 and 50 & Fast-acting Human Insulin in Patients With Type 1 Diabetes, A Randomised, Quadruple Crossover Trial
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 入组人数
- 24
- 试验地点
- 1
- 主要终点
- Cmaxglu: Peak plasma glucose following test meal (breakfast). A comparison will be made between fast-acting human insulin vs. IAsp, BIAsp 50 and BIAsp 70, IAsp vs BIAsp 50 and BIAsp 70, BIAsp 50 vs. BIAsp 70.
研究概览
简要总结
The hypothesis is that an optimal formulation of fast acting and intermediary acting insulin analogues will improve post prandial glycaemic control in patients with type 1 diabetes
详细描述
This trial is a single centre, open-label, randomised 4 period cross-over trial, comparing the pk and pd profiles of IAsp, BIAsp 50, BIAsp 70 and Fast-acting Human Insulin after a standard test meal in subjects with type 1 diabetes. The profiles will be derived over a 12-hour period after subcutaneous injection in the abdominal region with a single dose of IAsp, BIAsp 50, BIAsp 70 or Fast-acting Human Insulin at a test meal. The trial consists of a screening period of 4-21 days and 4 treatment visits.
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 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Informed consent obtained before any trial-related activities.
- •Diagnosed type 1 diabetes before the age of 40 and on insulin treatment within one year of diagnosis.
- •Insulin treatment of any regime for more than one year at time of inclusion.
- •Total insulin demand ≥ 0,4 U/IU/kg/24 hrs
- •HbA1c between 7% and 12% (both values included).
- •Age ≥ 18 years.
- •BMI between 18 and 35 kg /m2 (including both values).
排除标准
- •Known or suspected allergy to trial product(s) or related products.
- •Recurrent major hypoglycaemic episodes.
- •Heart: Unstable Angina Pectoris, AMI < 12 months or heart insufficiency classified according to NYHA III-IV
- •Blood Pressure: Severe uncontrolled hypertension with BP > 180/110 mmHg, sitting
- •Liver: Impaired hepatic function corresponding to serum-ALAT or basic phosphatase > 2 x upper reference limit of the local laboratory.
- •Kidneys: Impaired renal function corresponding to serum-creatinin > 150 μmol/l according to the local laboratory.
- •Any disease judged by the investigator to affect the trial.
- •Pregnancy, breast-feeding or the intention of becoming pregnant or fertile women not using adequate contraceptive measures - adequate contraceptive method is sterilisation, hysterectomy or current use of contraceptive pills or intra uterine device.
研究组 & 干预措施
Insulin therapy
Insulin Aspart, Biphasic Insulin Aspart 70 and 50 & Fast-acting Human Insulin
干预措施: Insulin Aspart, BIAsp 70, BIAsp50, Human Insulin (Drug)
结局指标
主要结局
Cmaxglu: Peak plasma glucose following test meal (breakfast). A comparison will be made between fast-acting human insulin vs. IAsp, BIAsp 50 and BIAsp 70, IAsp vs BIAsp 50 and BIAsp 70, BIAsp 50 vs. BIAsp 70.
时间窗: 12 hours following a standard test meal (breakfast)
次要结局
- AUCins: The area under insulin aspart/human insulin concentration (0-12, 0-6, 6-12, 0-4, 4-8, 8-12 hours after test meal) after a single injection of one of the four insulins: IAsp, Biphasic insulin aspart 50 and 70 & fast-acting human insulin(12 hours following a standard test meal (breakfast))
- Serum GH, total IGF-I, IGF-I bioactivity, IGFBP-1, IGFBP-2, binary complex of IGF-I, IGFBP-3 and the acid-labile subunit (ALS)(12 hours following a standard test meal (breakfast))
- tmaxins: Time to maximum serum insulin aspart/human insulin concentration(12 hours following a standard test meal (breakfast))
- AUCglu: The area under the plasma glucose concentration (0-12, 0-6, 6-12, 0-4, 4-8, 8-12 hours after test meal) after a single injection of one of the four insulins: IAsp, Biphasic insulin aspart 50 and 70 & fast-acting human insulin(12 hours following a standard test meal (breakfast))