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

A Trial Comparing the Pharmacokinetic and Pharmacodynamic Properties of NN1250 After Different Routes of Administration in Healthy Subjects

Status

Completed

Phases

Phase 1

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT01151072

Enrollment

Registered

2010-06-25

Start date

2010-06-30

Completion date

2010-10-31

Last updated

2017-01-20

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Diabetes, Healthy

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.

Interventions

DRUGinsulin degludec

Each subject was randomly allocated to five single dose administrations of NN1250 subcutaneously (under the skin) in the thigh, the abdomen (stomach) and the deltoid (shoulder), intramuscularly (into the muscle) in the thigh and intravenously (into the vein), respectively, on five separate dosing visits.

Study design

Allocation

RANDOMIZED

Intervention model

CROSSOVER

Primary purpose

TREATMENT

Masking

NONE

Eligibility

Sex/Gender

ALL

Age

18 Years to 55 Years

Healthy volunteers

Yes

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

Design outcomes

Primary

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

Secondary

Measure	Time frame
Area under the serum Insulin Degludec concentration-time curve (only for intramuscular administration)	From 0 to 120 hours after single-dose
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
Back-extrapolated initial serum Insulin Degludec concentration after single-dose (only for intravenous administration)	At time zero after dosing

Countries

Germany

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026