Patients with type 1 diabetes MedDRA version: 9.1 Level: LLT Classification code 10012608 Term: Diabetes mellitus insulin-dependent
Conditions
Interventions
Trade Name: NovoRapid
Product Name: insulin aspart
Pharmaceutical Form: Solution for injection
Trade Name: NovoMix 50
Product Name: Biphasic insulin aspart 50
Pharmaceutical Form: Solution for injec
Sponsors
Department of Medicine M, Aarhus University Hospital
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1. Informed consent obtained before any trial-related activities. 2. Diagnosed type 1 diabetes before the age of 40 and on insulin treatment within one year of diagnosis. 3. Insulin treatment of any regime for more than one year at time of inclusion. 4. Total insulin demand = 0,4 U/IU/kg/24 hrs 5. HbA1c between 7% and 12% (both values included). 6. Age = 18 years. 7. BMI between 18 and 35 kg /m2 (including both values). Are the trial subjects under 18? no Number of subjects for this age range: F.1.2 Adults (18-64 years) yes F.1.2.1 Number of subjects for this age range F.1.3 Elderly (>=65 years) yes F.1.3.1 Number of subjects for this age range
Exclusion criteria
Exclusion criteria: 1. Known or suspected allergy to trial product(s) or related products. 2. Recurrent major hypoglycaemic episodes. 3. Heart: Unstable Angina Pectoris, AMI 180/110 mmHg, sitting 5. Liver: Impaired hepatic function corresponding to serum-ALAT or basic phosphatase > 2 x upper reference limit of the local laboratory. 6. Kidneys: Impaired renal function corresponding to serum-creatinin > 150 µmol/l according to the local laboratory. 7. Any disease judged by the investigator to affect the trial. 8. 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 |
|---|---|
| Main Objective: The objective is to describe pharmacodynamic (PD) and pharmacokinetic (PK) profiles of Insulin Aspart (IAsp), Biphasic Insulin Aspart (BIAsp) 50 and 70 & fast-acting human insulin for a period of 12 hours following a standard test meal on four days respectively in subjects with type 1 diabetes;Secondary Objective: •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 (NovoRapid®), Biphasic insulin aspart 50 and 70 & fast-acting human insulin (Actrapid®). •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 (NovoRapid®), Biphasic insulin aspart 50 and 70 & fast-acting human insulin (Actrapid®). •tmaxins: Time to maximum serum insulin aspart/human insulin concentration •serum GH, immunoreactive IGF-I, bioactive IGF-I, IGFBP-1 and tissue-available IGF-I In addition: •Adverse events •hypoglycaemic episodes ;Primary end point(s): • Cmaxglu: Peak plasma glucose following test meal (breakfast). | — |
Countries
Denmark
Outcome results
None listed