Status:
COMPLETED
Investigation of the Impact of Different Application Volumes of Insulin Aspart in Subjects With Type 1 Diabetes
Lead Sponsor:
Medical University of Graz
Collaborating Sponsors:
European Commission
Conditions:
Type 1 Diabetes
Eligibility:
All Genders
18-60 years
Phase:
PHASE1
Brief Summary
Rationale: For the development of a closed loop system, faster insulin absorption after bolus administration could help to reduce the system's delay and thus increase patient safety. It has been shown...
Eligibility Criteria
Inclusion
- Informed consent obtained after being advised of the nature of the study
- Male or female aged 18-60 years (both inclusive)
- Type 1 diabetes treated with multiple daily insulin injection or continuous subcutaneous insulin infusion for 12 months
- Fasting C-peptide \< 0.3nmol/L
- Body mass index 20.0-28.0 kg/m² (both inclusive)
- HbA1c \< 10%
Exclusion
- Female of childbearing potential who is pregnant, breast-feeding or intend to become pregnant or is not using adequate contraceptive methods
- Skin pathology or condition prohibiting needle insertion/insulin administration as judged by the investigator
- History of bleeding disorder
- Current participation in another clinical study
- Significant acute or chronic illness that might interfere with subject safety or integrity of results as judged by the investigator
- Smoker (defined as \>5 cigarettes/d)
- Lipodystrophy
- Current treatment with systemic (oral or i.v.) corticosteroids, monoamine oxidase (MAO) inhibitors, non-selective beta-blockers, growth hormone, herbal products or non-routine vitamins. Furthermore, thyroid hormones are not allowed unless the use of these has been stable during the past 3 months.
- Significant history of alcoholism or drug abuse or a positive result in urine drug/alcohol screen.
- Study Day
Key Trial Info
Start Date :
April 1 2011
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
June 1 2011
Estimated Enrollment :
12 Patients enrolled
Trial Details
Trial ID
NCT01399346
Start Date
April 1 2011
End Date
June 1 2011
Last Update
April 20 2012
Active Locations (1)
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1
Medical University of Graz
Graz, Austria, 8036