Status:
COMPLETED
Pharmacology of Insulin Injected With Jet-injection in Diabetes
Lead Sponsor:
Radboud University Medical Center
Collaborating Sponsors:
European Pharma Group (EPG)
Conditions:
Diabetes Mellitus
Eligibility:
All Genders
18-70 years
Phase:
PHASE4
Brief Summary
A previous study showed that absorption and glucose-lowering action of rapid-acting insulin analogues occurred twice as fast when these analogues were administered by jet injection technology rather t...
Detailed Description
A previous study showed that absorption and glucose-lowering action of rapid-acting insulin analogues occurred twice as fast when these analogues were administered by jet injection technology rather t...
Eligibility Criteria
Inclusion
- Body-mass index 18-32 kg/m2
- Stable glycaemic control with HbA1c 6.0-9.0%
- Duration of diabetes \>1 year
- Insulin use at least once daily or with subcutaneous pump
- Blood pressure \<160/90 mmHg
Exclusion
- Inability to provide informed consent
- Requirement of \<8 units of rapid-acting insulin (analogue) before meals
- Chronic use of sulphonylurea derivatives, GLP-1 based treatments, acarbose or thiazolidinediones
- Treatment with prednisolone, non-steroidal anti-inflammatory drugs (NSAIDs), immunosuppressive agents, cytostatic drugs, hormone therapy except insulin, thyroid supplementation and oral anticonceptives
- Known allergy to aspart insulin
- Symptomatic diabetic neuropathy
- History of a major cardiovascular disease event (myocardial infarction, stroke, symptomatic peripheral artery disease, coronary bypass surgery, percutaneous coronary or peripheral artery angioplasty) in the past 6 months
- Pregnancy or the intention to become pregnant
Key Trial Info
Start Date :
September 1 2011
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
July 1 2012
Estimated Enrollment :
24 Patients enrolled
Trial Details
Trial ID
NCT01438632
Start Date
September 1 2011
End Date
July 1 2012
Last Update
March 12 2013
Active Locations (1)
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1
Department of general internal medicine 463, section Diabetes, Radboud University Nijmegen Medical Centre
Nijmegen, Gelderland, Netherlands, 6500 HB