Diabetes Mellitus, Type 1
Conditions
Keywords
Pharmacokinetic profile, Pharmacodynamic profile, insulin, jet injector
Brief summary
The purpose of this study is to compare the pharmacological profile of insulin administered with jet-injection with that of insulin injected with a conventional insulin pen.
Interventions
DEVICEjet injector (SQ pen/Novopen III)
The rapid-acting insulin analogue insulin aspart (Novorapid®), at a dose of 0.2 units per kg body weight, will be injected subcutaneously. On one experimental day insulin will be injected with the jet injector and placebo with the conventional insulin pen. On the other experimental day insulin will be injected with the conventional insulin pen and placebo with the jet injector.
Sponsors
Radboud University Medical Center
Study design
Allocation
RANDOMIZED
Intervention model
CROSSOVER
Primary purpose
TREATMENT
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to 50 Years
Healthy volunteers
Yes
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)
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| (time to) maximal glucose infusion rate | 0-8 hours after insulin injection |
Secondary
| Measure | Time frame |
|---|---|
| (time to) maximal insulin concentration | 0-8 hours after insulin injection |
Countries
Netherlands
Outcome results
None listed