Pharmacology of Insulin Injected With Jet-Injection

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

Sponsors

Lead Sponsor: Radboud University

Source Radboud University
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.

Overall Status Completed
Start Date November 2009
Completion Date November 2010
Primary Completion Date November 2010
Phase N/A
Study Type Interventional
Primary Outcome
Measure Time Frame
(time to) maximal glucose infusion rate 0-8 hours after insulin injection
Secondary Outcome
Measure Time Frame
(time to) maximal insulin concentration 0-8 hours after insulin injection
Enrollment 48
Condition
Intervention

Intervention Type: Device

Intervention Name: jet injector (SQ pen/Novopen III)

Description: 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.

Arm Group Label: healthy low dose insulin

Intervention Type: Device

Intervention Name: jet injector (SQ pen/Novopen III)

Description: 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.

Eligibility

Criteria:

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)

Gender: All

Minimum Age: 18 Years

Maximum Age: 50 Years

Healthy Volunteers: Accepts Healthy Volunteers

Overall Official
Last Name Role Affiliation
Cees J Tack, MD PhD Study Chair Radboud University
Location
Facility: Radboud University Nijmegen Medical Centre
Location Countries

Netherlands

Verification Date

September 2009

Responsible Party

Name Title: Cees Tack, MD PhD

Organization: Radboud University Nijmegen Medical Centre

Keywords
Has Expanded Access No
Condition Browse
Number Of Arms 3
Arm Group

Label: healthy low dose insulin

Type: Experimental

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.

Label: healthy high dose insulin

Type: Experimental

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.

Label: type 1 diabetes mellitus

Type: Experimental

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.

Study Design Info

Allocation: Randomized

Intervention Model: Crossover Assignment

Primary Purpose: Treatment

Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)

Source: ClinicalTrials.gov