Pharmacology of Insulin Injected With Jet-Injection
Diabetes Mellitus, Type 1
About this trial
This is an interventional treatment trial for Diabetes Mellitus, Type 1 focused on measuring Pharmacokinetic profile, Pharmacodynamic profile, insulin, jet injector
Eligibility Criteria
Inclusion Criteria:
- Age 18-50 years
- Body-mass index 18-28 kg/m2
- Blood pressure <160/90 mmHg
- Stable glycaemic control with HbA1c 6.5-9.0% (for patients with type 1 diabetes mellitus)
- Duration of diabetes >1 year (for patients with type 1 diabetes mellitus)
Exclusion Criteria:
- 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)
- Chronic use of medication other than insulin or low-dose angiotensin-converting enzyme (ACE) inhibitor or angiotensin receptor blocker (ARB) treatment (for patients with type 1 diabetes mellitus)
- Type 2 diabetes in first-degree relatives (for healthy subjects)
- History of a major cardiovascular disease event (myocardial infarction, stroke, symptomatic peripheral artery disease, coronary bypass surgery, percutaneous coronary or peripheral artery angioplasty)
- Pregnancy
- Macroalbuminuria, i.e. urinary albumin excretion >200 microg/min in collected urine sample or urinary albumin-to-creatinine ratio >300 mg/g in spot urine sample (for patients with type 1 diabetes mellitus)
- Symptomatic diabetic neuropathy (for patients with type 1 diabetes mellitus)
- Proliferative diabetic retinopathy (a history of proliferative retinopathy that was successfully treated with laser coagulopathy is not an exclusion criterion) (for patients with type 1 diabetes mellitus)
Sites / Locations
- Radboud University Nijmegen Medical Centre
Arms of the Study
Arm 1
Arm 2
Arm 3
Experimental
Experimental
Experimental
healthy low dose insulin
healthy high dose insulin
type 1 diabetes mellitus
16 healthy non-diabetic volunteers. The type of insulin tested will be the rapid-acting insulin analogue insulin aspart (Novorapid®), at a dose of 0.2 units per kg body weight.
16 healthy non-diabetic volunteers. The type of insulin tested will be the rapid-acting insulin analogue insulin aspart (Novorapid®), at a dose of 0.4 units per kg body weight.
16 people with type 1 diabetes mellitus. The type of insulin tested will be the rapid-acting insulin analogue insulin aspart (Novorapid®), at a dose of 0.4 units per kg body weight.