Investigation of the Impact of Different Application Volumes of Insulin Aspart in Subjects With Type 1 Diabetes
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.
|Study Design:||Allocation: Randomized
Endpoint Classification: Pharmacokinetics/Dynamics Study
Intervention Model: Crossover Assignment
Masking: Open Label
Primary Purpose: Basic Science
|Official Title:||A Single-center, Randomized, Controlled, 2-period Cross-over, Open-labelled Trial to Evaluate the Impact of Different Application Volumes on Pharmacokinetic and Pharmacodynamic Properties of Insulin Aspart in Subjects With Type 1 Diabetes|
- tmax(ins), time to maximum observed serum insulin aspart concentration [ Time Frame: 8 hours ] [ Designated as safety issue: No ]
- t10%max(ins), time to reach 10% of maximum observed serum insulin aspart concentration [ Time Frame: 8 hours ] [ Designated as safety issue: No ]
|Study Start Date:||April 2011|
|Study Completion Date:||June 2011|
|Primary Completion Date:||June 2011 (Final data collection date for primary outcome measure)|
Experimental: 1 bolus of insulin aspart 18 IU
Subcutaneous administration of insulin aspart as one bolus of 18 IU at one injection site.
Drug: Insulin aspart
Application of 18 IU insulin aspart as one bolus at one injection site
Experimental: 9 bolus of insulin aspart a 2 IU
Subcutaneous administration of insulin aspart as 9 separately and simultaneously applied bolus of 2 IU at 9 separate injection sites
Drug: Insulin aspart
Application of 18 IU insulin aspart as 9 bolus of 2 IU each at nine injection sites
|Medical University of Graz|
|Graz, Austria, 8036|
|Principal Investigator:||Thomas R Pieber, MD||Medical University of Graz|