Type 1 Diabetes
Conditions
Keywords
Insulin aspart, Type 1 diabetes, Glucose clamp, Pharmacodynamics, Pharmacokinetics, Rapid Acting Insulin Analog
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 that regular insulin absorption is faster when injecting insulin with a sprinkler needle (containing holes in the walls and being sealed at the tip). The current study will evaluate the impact of different application volumes on pharmacokinetic and pharmacodynamic properties of rapid acting insulin analogue (insulin aspart). Objective: To compare the pharmacokinetic response (based on the time to maximum observed serum insulin concentration) and pharmacodynamic properties of rapid acting insulin aspart after subcutaneous injection of a defined dose (volume) at 1 versus 9 injection sites in patients with type 1 diabetes. Study design: Monocentric, randomised, controlled, two-arm cross-over intervention study. Population: Twelve type 1 diabetic subjects Intervention: The investigational treatment is the subcutaneous administration of insulin aspart either as one bolus of 18 IU at one injection site or as 9 separately and simultaneously applied bolus of 2 IU each at 9 separate injection sites. Serum and plasma samples to assess pharmacodynamic and pharmacokinetic properties will be taken during an 8-hour clamp experiment. Patients will undergo both investigational treatments in a randomized order; between the two clamp visits there will be a wash-out period of 5-21 days. Main study endpoint: Time to maximum observed serum insulin aspart concentration.
Interventions
DRUGInsulin aspart
Application of 18 IU insulin aspart as one bolus at one injection site
Sponsors
European Commission
Medical University of Graz
Study design
Allocation
RANDOMIZED
Intervention model
CROSSOVER
Primary purpose
BASIC_SCIENCE
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 60 Years
Healthy volunteers
No
Inclusion criteria
* 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 criteria
* 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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| tmax(ins), time to maximum observed serum insulin aspart concentration | 8 hours |
Secondary
| Measure | Time frame |
|---|---|
| t10%max(ins), time to reach 10% of maximum observed serum insulin aspart concentration | 8 hours |
Countries
Austria
Outcome results
None listed