Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
NA
48 participants
INTERVENTIONAL
2009-11-30
2010-11-30
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
CROSSOVER
TREATMENT
QUADRUPLE
Study Groups
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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.
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.
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.
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.
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.
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.
Interventions
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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.
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* 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
* 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)
18 Years
50 Years
ALL
Yes
Sponsors
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Radboud University Medical Center
OTHER
Responsible Party
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Radboud University Nijmegen Medical Centre
Principal Investigators
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Cees J Tack, MD PhD
Role: STUDY_CHAIR
Radboud University Medical Center
Locations
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Radboud University Nijmegen Medical Centre
Nijmegen, P.O. Box 9101, Netherlands
Countries
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Other Identifiers
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PKPD_SQ_1
Identifier Type: -
Identifier Source: org_study_id
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