Pharmacology of Insulin Injected With Jet-Injection

Radboud University Medical Center

Status: Completed

Conditions: Diabetes Mellitus, Type 1

Treatments: Device: jet injector (SQ pen/Novopen III)

Study type: Interventional

Funder types: Other

Identifiers

NCT00983775

PKPD_SQ_1

Details and patient eligibility

About

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.

Enrollment: 48 estimated patients

Sex: All

Ages: 18 to 50 years old

Volunteers: Accepts Healthy Volunteers

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)

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Crossover Assignment

Masking: Quadruple Blind

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48 participants in 3 patient groups

healthy low dose insulin

Experimental group

Description:

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.

Treatment:

Device: jet injector (SQ pen/Novopen III)

Device: jet injector (SQ pen/Novopen III)

healthy high dose insulin

Experimental group

Description:

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.

Treatment:

Device: jet injector (SQ pen/Novopen III)

Device: jet injector (SQ pen/Novopen III)

type 1 diabetes mellitus

Experimental group

Description:

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.

Treatment:

Device: jet injector (SQ pen/Novopen III)

Device: jet injector (SQ pen/Novopen III)