Pharmacology of Insulin Injected With Jet-Injection
August 10, 2011 updated by: Radboud University Medical Center
Pharmacokinetic and Pharmacodynamic Profile of Rapid Acting Insulin Injected by Needle-free Jet-injection
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.
Study Overview
Status
Completed
Conditions
Intervention / Treatment
Study Type
Interventional
Enrollment (Anticipated)
48
Phase
- Not Applicable
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
-
P.O. Box 9101
-
Nijmegen, P.O. Box 9101, Netherlands, 6500 HB
- Radboud University Nijmegen Medical Centre
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years to 50 years (ADULT)
Accepts Healthy Volunteers
Yes
Genders Eligible for Study
All
Description
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 Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: TREATMENT
- Allocation: RANDOMIZED
- Interventional Model: CROSSOVER
- Masking: QUADRUPLE
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
EXPERIMENTAL: healthy low dose insulin
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.
|
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.
Other Names:
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.
Other Names:
|
|
EXPERIMENTAL: healthy high dose insulin
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.
|
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.
Other Names:
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.
Other Names:
|
|
EXPERIMENTAL: type 1 diabetes mellitus
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.
|
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.
Other Names:
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.
Other Names:
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
|---|---|
|
(time to) maximal glucose infusion rate
Time Frame: 0-8 hours after insulin injection
|
0-8 hours after insulin injection
|
Secondary Outcome Measures
Outcome Measure |
Time Frame |
|---|---|
|
(time to) maximal insulin concentration
Time Frame: 0-8 hours after insulin injection
|
0-8 hours after insulin injection
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Investigators
- Study Chair: Cees J Tack, MD PhD, Radboud University Medical Center
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start
November 1, 2009
Primary Completion (ACTUAL)
November 1, 2010
Study Completion (ACTUAL)
November 1, 2010
Study Registration Dates
First Submitted
September 21, 2009
First Submitted That Met QC Criteria
September 23, 2009
First Posted (ESTIMATE)
September 24, 2009
Study Record Updates
Last Update Posted (ESTIMATE)
August 11, 2011
Last Update Submitted That Met QC Criteria
August 10, 2011
Last Verified
September 1, 2009
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- PKPD_SQ_1
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