A Comparison of Pharmacodynamics and Pharmacokinetics of Insulin Aspart, BIAsp70, BIAsp50 and Fast-acting Human Insulin
Phase 3
Completed
- Conditions
- Diabetes Mellitus, Type 1
- Interventions
- Drug: Insulin Aspart, BIAsp 70, BIAsp50, Human Insulin
- Registration Number
- NCT00888732
- Lead Sponsor
- University of Aarhus
- Brief Summary
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
- Detailed Description
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.
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 24
Inclusion Criteria
- 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).
Exclusion Criteria
- 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.
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- CROSSOVER
- Arm && Interventions
Group Intervention Description Insulin therapy Insulin Aspart, BIAsp 70, BIAsp50, Human Insulin Insulin Aspart, Biphasic Insulin Aspart 70 and 50 \& Fast-acting Human Insulin
- Primary Outcome Measures
Name Time Method 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. 12 hours following a standard test meal (breakfast)
- Secondary Outcome Measures
Name Time Method 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)
Trial Locations
- Locations (1)
Dept of Medicine M, Aarhus University Hospital
🇩🇰Aarhus, Denmark