Pharmacology of Insulin Injected With Jet-Injection

Not Applicable

Completed

• Conditions: Diabetes Mellitus, Type 1
• Interventions: Device: jet injector (SQ pen/Novopen III)

• Registration Number: NCT00983775
• Lead Sponsor: Radboud University Medical Center

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.

Detailed Description

Not available

Study Timeline

• Status Verified: 2009-09
• Study First Submitted: 2009-09-21
• Study First Submitted QC: 2009-09-23
• Study First Posted: 2009-09-24
• Study Start: 2009-11
• Primary Completion: 2010-11
• Study Completion: 2010-11
• Last Update Submitted: 2011-08-10
• Last Update Posted: 2011-08-11

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 48

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)

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: CROSSOVER

Arm && Interventions

Group	Intervention	Description
healthy low dose insulin	jet injector (SQ pen/Novopen III)	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.
healthy high dose insulin	jet injector (SQ pen/Novopen III)	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.
type 1 diabetes mellitus	jet injector (SQ pen/Novopen III)	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.

Primary Outcome Measures

Name	Time	Method
(time to) maximal glucose infusion rate	0-8 hours after insulin injection

Secondary Outcome Measures

Name	Time	Method
(time to) maximal insulin concentration	0-8 hours after insulin injection

Trial Locations

Locations (1)

Radboud University Nijmegen Medical Centre; 🇳🇱 Nijmegen, P.O. Box 9101, Netherlands