Diabetes Mellitus, Type 1
Conditions
Keywords
Diabetes
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.
Interventions
DRUGInsulin Aspart, BIAsp 70, BIAsp50, Human Insulin
0.2 U/IU/kg subcutaneous injection, single dose
Sponsors
Novo Nordisk A/S
University of Aarhus
Study design
Allocation
RANDOMIZED
Intervention model
CROSSOVER
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 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
| Measure | Time frame |
|---|---|
| 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) |
| 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) |
| tmaxins: Time to maximum serum insulin aspart/human insulin concentration | 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) |
Countries
Denmark
Outcome results
None listed