Pharmacology of Insulin Injected With Jet-Injection

Study Overview
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Brief Summary
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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.

Official Title
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Pharmacokinetic and Pharmacodynamic Profile of Rapid Acting Insulin Injected by Needle-free Jet-injection

Conditions
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Diabetes Mellitus, Type 1

Intervention / Treatment
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* Device: jet injector (SQ pen/Novopen III)
* Device: jet injector (SQ pen/Novopen III)


Participation Criteria
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Eligibility Criteria
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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)

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 50 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Quadruple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: healthy low dose insulin<br>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. | Device: jet injector (SQ pen/Novopen III)<br>* 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.<br>* Other names: Novopen III;|
| Experimental: healthy high dose insulin<br>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. | Device: jet injector (SQ pen/Novopen III)<br>* The rapid-acting insulin analogue insulin aspart (Novorapid®), at a dose of 0.4 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.<br>* Other names: Novopen III;|
| Experimental: type 1 diabetes mellitus<br>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. | Device: jet injector (SQ pen/Novopen III)<br>* The rapid-acting insulin analogue insulin aspart (Novorapid®), at a dose of 0.4 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.<br>* Other names: Novopen III;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| (time to) maximal glucose infusion rate |  | 0-8 hours after insulin injection | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| (time to) maximal insulin concentration |  | 0-8 hours after insulin injection | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Pharmacokinetic profile, Pharmacodynamic profile, insulin, jet injector