A Trial Comparing the Effect of NN1250 After Different Routes of Injection in Healthy Subjects

Phase 1

Completed

• Conditions: Diabetes; Healthy
• Interventions: Drug: insulin degludec

• Registration Number: NCT01151072
• Lead Sponsor: Novo Nordisk A/S

Brief Summary

This trial was conducted in Europe. The aim of this clinical trial was to compare the exposure and effect of NN1250 (insulin degludec) after different routes of injection in healthy subjects.

Detailed Description

Not available

Study Timeline

• Study Start: 2010-06
• Study First Submitted: 2010-06-24
• Study First Submitted QC: 2010-06-24
• Study First Posted: 2010-06-25
• Primary Completion: 2010-10
• Study Completion: 2010-10
• Status Verified: 2017-01
• Last Update Submitted: 2017-01-19
• Last Update Posted: 2017-01-20

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 20

Inclusion Criteria

• Considered generally healthy upon completion of medical history, physical examination, vital signs and ECG (electrocardiogram), as judged by the Investigator
• Body mass index 18.0-27.0 kg/m^2 (both inclusive)

Exclusion Criteria

• Subject who has donated any blood or plasma in the past month or more than 500 mL within 3 months prior to screening
• Smoker (defined as a subject who is smoking more than 5 cigarettes or the equivalent per day)
• Not able or willing to refrain from smoking and use of nicotine gum or transdermal nicotine patches during the inpatient period

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: CROSSOVER

Arm && Interventions

Group	Intervention	Description
IDeg i.m. thigh	insulin degludec	-
IDeg s.c. abdomen	insulin degludec	-
IDeg i.v.	insulin degludec	-
IDeg s.c. deltoid	insulin degludec	-
IDeg s.c. thigh	insulin degludec	-

Primary Outcome Measures

Name	Time	Method
Area under the serum Insulin Degludec concentration-time curve (only for subcutaneous administration)	From 0 to 120 hours after single-dose

Secondary Outcome Measures

Name	Time	Method
Area under the serum Insulin Degludec concentration-time curve (only for intravenous administration)	From 0 to 30 hours after single-dose
Maximum observed serum Insulin Degludec concentration after single-dose (only for subcutaneous and intramuscular administration)	Within 0 to 120 hours after dosing
Area under the serum Insulin Degludec concentration-time curve (only for intramuscular administration)	From 0 to 120 hours after single-dose
Back-extrapolated initial serum Insulin Degludec concentration after single-dose (only for intravenous administration)	At time zero after dosing

Trial Locations

Locations (1)

Novo Nordisk Investigational Site; 🇩🇪 Neuss, Germany