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

NCT01151072 | Completed Phase 1

• 3 other identifiers: NN1250-19922009-017217-30U1111-1113-6783
• Study Type: interventional
• Target: 20
• Locations: 1 country
• Sites: 1

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.

Conditions

Diabetes; Healthy

Outcome Measures

Primary Outcomes (1)

• Area under the serum Insulin Degludec concentration-time curve (only for subcutaneous administration)

  From 0 to 120 hours after single-dose

Secondary Outcomes (4)

• 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

Study Arms (5)

IDeg i.m. thigh

EXPERIMENTAL

Drug: insulin degludec

IDeg i.v.

EXPERIMENTAL

Drug: insulin degludec

IDeg s.c. abdomen

EXPERIMENTAL

Drug: insulin degludec

IDeg s.c. deltoid

EXPERIMENTAL

Drug: insulin degludec

IDeg s.c. thigh

EXPERIMENTAL

Drug: insulin degludec

Interventions

insulin degludec DRUG

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.

IDeg i.m. thigh; IDeg i.v.; IDeg s.c. abdomen; IDeg s.c. deltoid; IDeg s.c. thigh

Eligibility Criteria

• Age: 18 Years - 55 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• 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)

You may not qualify if:

• 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

Sponsors & Collaborators

• Novo Nordisk A/S: lead

Study Sites (1)

Novo Nordisk Investigational Site

Neuss, 41460, Germany

Location

Related Publications (1)

• Nosek L, Coester HV, Roepstorff C, Thomsen HF, Kristensen NR, Haahr H, Heise T. Glucose-lowering effect of insulin degludec is independent of subcutaneous injection region. Clin Drug Investig. 2014 Sep;34(9):673-9. doi: 10.1007/s40261-014-0218-x.

  PMID: 25124362 RESULT

Related Links

• Clinical Trials at Novo Nordisk

MeSH Terms

Conditions

Diabetes Mellitus

Interventions

insulin degludec

Condition Hierarchy (Ancestors)

Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases; Endocrine System Diseases

Study Officials

• Global Clinical Registry (GCR, 1452)

  Novo Nordisk A/S

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: CROSSOVER
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 24, 2010
• First Posted: June 25, 2010
• Study Start: June 1, 2010
• Primary Completion: October 1, 2010
• Study Completion: October 1, 2010
• Last Updated: January 20, 2017

Record last verified: 2017-01

Locations

DE (1)