Diabetes mellitus type I MedDRA version: 14.0 Level: LLT Classification code 10012608 Term: Diabetes mellitus insulin-dependent System Organ Class: 10027433 - Metabolism and nutrition disorders
Conditions
Interventions
Trade Name: Novorapid
Product Name: Novorapid
Pharmaceutical Form: Solution for injection
INN or Proposed INN: INSULIN ASPART
CAS Number: 116094-23-6
Concentration unit: U/ml unit(s)/millilitre
Concen
Sponsors
Medizinische Universität Graz
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: Informed consent obtained after being advised of the nature of the study Male or female aged 18-60 years (both inclusive) Type 1 diabetes treated with multiple daily insulin injection or continuous subcutaneous insulin infusion for 12 months Fasting C-peptide =65 years) no F.1.3.1 Number of subjects for this age range
Exclusion criteria
Exclusion criteria: Female of childbearing potential who is pregnant, breast-feeding or intend to become pregnant or is not using adequate contraceptive methods Skin pathology or condition prohibiting needle insertion/insulin administration as judged by the investigator History of bleeding disorder Current participation in another clinical study Significant acute or chronic illness that might interfere with subject safety or integrity of results as judged by the investigator Smoker (defined as >5 cigarettes/d) Lipodystrophy Current treatment with systemic (oral or i.v.) corticosteroids, monoamine oxidase (MAO) inhibitors, non-selective beta-blockers, growth hormone, herbal products or non-routine vitamins. Furthermore, thyroid hormones are not allowed unless the use of these has been stable during the past 3 months. Significant history of alcoholism or drug abuse or a positive result in urine drug/alcohol screen.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: To compare the pharmacokinetic response (based on the time to maximum observed serum insulin concentration) of rapid acting insulin aspart after sub-cutaneous injection of a defined dose (volume) at 1 versus 9 injection sites in patients with type 1 diabetes.;Secondary Objective: To characterize and compare the pharmacokinetic and pharmacodynamic profiles of rapid acting insulin aspart after sub-cutaneous injection of a defined dose (volume) at 1 versus 9 injection sites in patients with T1DM. To assess the safety and tolerability of rapid acting insulin aspart after subcutaneous injection of a defined dose (volume) at 1 versus 9 injection sites in patients with T1DM. ;Primary end point(s): Primary Pharmacokinetic Endpoint: tmax(ins), time to maximum observed serum insulin aspart concentration;Timepoint(s) of evaluation of this end point: During Clamp Experiment | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary end point(s): Secondary Pharmacokinetic Endpoints: t10%max(ins), time to reach 10% of maximum observed serum insulin aspart concentration t50%max(ins), time to reach 50% of maximum observed serum insulin aspart concentration Cmax(ins), maximum observed serum insulin aspart concentration AUC0-8(ins), area under the serum insulin aspart concentration-time curve from 0-8 hours AUC0-0.5h(ins), AUC0-1h(ins), AUC0-2h(ins), AUC0-4h(ins), AUC0-6h(ins), area under the serum insulin aspart concentration-time curve for different time frames AUC0-tmax(ins), area under the serum insulin aspart concentration-time curve from 0 to timepoint of maximum observed serum insulin aspart concentration AUC0-8(ins), area under the serum insulin aspart concentration-time curve from 0 to infinity Onset of appearance, time from trial product administration until the first time serum insulin aspart concentration > 30 pmol/L after dosing Secondary Pharmacodynamic Endpoints: tmax(GIR), time to maximum glucose infusion rate t10% max(GIR), time to reach 10% of maximum glucose infusion rate t50% max(GIR), time to reach 50% of maximum glucose infusion rate GIRmax, maximum glucose infusion rate AUC0-8h(GIR), area under the glucose infusion rate curve from 0-8 hours AUC0-0.5h(GIR), AUC0-1h(GIR), AUC0-2h(GIR), AUC0-4h(GIR), AUC0-6h(GIR), area under the glucose infusion rate curve for different time frames AUC0-tmax(GIR), area under the glucose infusion rate curve from 0 to time to maximum glucose infusion rate AUC0-8(GIR), area under the glucose infusion rate curve from 0 ti infinity Onset of action, defined as time from trial product administration until plasma glucose concentration has decreased at least 5mg/dl from baseline (t=0) Duration of action, defined as time from onset of action until plasma glucose exceeds 150mg/dl without any glucose infusion Safety Endpoints: Adverse events Laboratory safety variable Onset of appearance, time from trial product administration until the firs | — |
Countries
Austria
Contacts
Public ContactClinical Trial Administration
Medizinische Universität Graz/Universitätsklinik für Innere Medizin/Klin. Abt. für Endokrinologie und Stoffwechsel
Outcome results
None listed