NCT01399346

Investigation of the Impact of Different Application Volumes of Insulin Aspart in Subjects With Type 1 Diabetes

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

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 12 (actual)
• Sponsor: Medical University of Graz · Academic / Other
• Sex: All
• Age: 18 Years – 60 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Type 1 Diabetes

Interventions

Type	Name	Description
DRUG	Insulin aspart	Application of 18 IU insulin aspart as one bolus at one injection site
DRUG	Insulin aspart	Application of 18 IU insulin aspart as 9 bolus of 2 IU each at nine injection sites

Timeline

• Start date: 2011-04-01
• Primary completion: 2011-06-01
• Completion: 2011-06-01
• First posted: 2011-07-21
• Last updated: 2012-04-20

Locations

1 site across 1 country: Austria