Status:
COMPLETED
Pharmacology of Insulin Injected With Jet-Injection
Lead Sponsor:
Radboud University Medical Center
Conditions:
Diabetes Mellitus, Type 1
Eligibility:
All Genders
18-50 years
Phase:
NA
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.
Eligibility Criteria
Inclusion
- 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
- 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)
Key Trial Info
Start Date :
November 1 2009
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
November 1 2010
Estimated Enrollment :
48 Patients enrolled
Trial Details
Trial ID
NCT00983775
Start Date
November 1 2009
End Date
November 1 2010
Last Update
August 11 2011
Active Locations (1)
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1
Radboud University Nijmegen Medical Centre
Nijmegen, P.O. Box 9101, Netherlands, 6500 HB