Pharmacology of Insulin Injected With Jet-Injection

Diabetes Mellitus, Type 1 Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00983775
• Other study ID #: PKPD_SQ_1
• Status: Completed
• Phase: N/A
• First received: September 21, 2009
• Last updated: August 10, 2011
• Start date: November 2009
• Est. completion date: November 2010

Study information

• Verified date: September 2009
• Source: Radboud University
• Contact: n/a
• Is FDA regulated: No
• Health authority: The Netherlands: Institutional Review BoardNetherlands: The Central Committee on Research Involving Human Subjects (CCMO)
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 48
• Est. completion date: November 2010
• Est. primary completion date: November 2010
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 18 Years to 50 Years

Eligibility

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

Allocation: Randomized, Endpoint Classification: Pharmacokinetics/Dynamics Study, Intervention Model: Crossover Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Diabetes Mellitus, Type 1

Intervention

Device:
• jet 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.
• jet injector (SQ pen/Novopen III)
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.

Locations

Country	Name	City	State
Netherlands	Radboud University Nijmegen Medical Centre	Nijmegen	P.O. Box 9101

Sponsors (1)

Lead Sponsor	Collaborator
Radboud University

Country where clinical trial is conducted

Netherlands, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	(time to) maximal glucose infusion rate		0-8 hours after insulin injection	No
Secondary	(time to) maximal insulin concentration		0-8 hours after insulin injection	No