type 1 diabetes mellitus MedDRA version: 12.0 Level: LLT Classification code 10045228 Term: Type I diabetes mellitus
Conditions
Interventions
Trade Name: Novorapid
Product Name: insulin-analogue aspart
Pharmaceutical Form: Solution for injection
Pharmaceutical form of the placebo: Solution for injection
Route of administration of the placeb
Sponsors
Radboud University Nijmegen Medical Centre
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: Inclusion criteria for healthy subjects • Age 18-50 years • Body-mass index 18-28 kg/m2 • Blood pressure 1 year • Blood pressure =65 years) no F.1.3.1 Number of subjects for this age range
Exclusion criteria
Exclusion criteria: Exclusion criteria for healthy subjects • Inability to provide informed consent • Chronic use of medication other than oral contraceptives or thyroid hormone replacement therapy (with stable euthyroidism for at least 3 months) • Type 2 diabetes in first-degree relatives • History of a major cardiovascular disease event (myocardial infarction, stroke, symptomatic peripheral artery disease, coronary bypass surgery, percutaneous coronary or peripheral artery angioplasty) • Pregnancy Exclusion criteria for patients with type 1 diabetes • Inability to provide informed consent • Chronic use of medication other than insulin, oral contraceptives, thyroid hormone replacement therapy (with stable euthyroidism for at least 3 months), or low-dose angiotensin-converting enzyme (ACE) inhibitor or angiotensin receptor blocker (ARB) treatment • Macroalbuminuria, i.e. urinary albumin excretion >200 ?g/min in collected urine sample or urinary albumin-to-creatinine ratio >300 mg/g in spot urine sample • Symptomatic diabetic neuropathy • Proliferative diabetic retinopathy (a history of proliferative retinopathy that was successfully treated with laser coagulopathy is not an exclusion criterion) • History of a major cardiovascular disease event (myocardial infarction, stroke, symptomatic peripheral artery disease, coronary bypass surgery, percutaneous coronary or peripheral artery angioplasty) • Pregnancy
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: To compare the pharmacokinetic and pharmacodynamic profile of the rapid-acting insulin analogue aspart (novorapid®) injected subcutaneously with jet-injection to that of the same insulin injected with a conventional pen in people without diabetes and in people with type 1 diabetes mellitus. Main study endpoint: Pharmacodynamic profile of insulin, based on parameters of the exogenous glucose infusion rate (GIR, in ml/min/kg) required to maintain euglycaemia;Secondary Objective: Secondary study endpoint: Pharmacokinetic profile of insulin, based on plasma insulin levels;Primary end point(s): Pharmacodynamic profile of insulin, based on parameters of the exogenous glucose infusion rate (GIR, in ml/min/kg) required to maintain euglycaemia: - Cmax (mg/min): maximal GIR during the 8-hour study (from timepoint 0) - Tmax (min): time to maximal GIR - AUC (g): area under the curve for GIR during the 8-hour study (from timepoint 0) - TAUC½ (min): time of 50% of glucose disposal, i.e. the median of the GIR profile | — |
Countries
Netherlands
Outcome results
None listed