Comparison of Two NN1250 Formulations in Healthy Volunteers

A Trial to Test for Bioequivalence Between Two NN1250 Formulations in Healthy Subjects

This trial was conducted in North America. The aim of this clinical trial was to investigate if two formulations of NN1250 (insulin degludec) have the same level of drug exposure to the body.

Study Overview

• Status: Completed
• Conditions: Healthy; Diabetes
• Intervention / Treatment: Drug: insulin degludec; Drug: insulin degludec

• Study Type: Interventional
• Enrollment (Actual): 27
• Phase: Phase 1

Contacts and Locations

Study Locations

• United States
  • California
    • Chula Vista, California, United States, 91911-1350
      • Novo Nordisk Clinical Trial Call Center

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 55 years (ADULT)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: TREATMENT
• Allocation: RANDOMIZED
• Interventional Model: CROSSOVER
• Masking: DOUBLE

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
EXPERIMENTAL: IDeg E	Drug: insulin degludec; Single dose of NN1250, formulation 1, 0.4U/kg body weight injected subcutaneously (under the skin); Drug: insulin degludec; Single dose of NN1250, formulation 2, 0.4U/kg body weight injected subcutaneously (under the skin)
EXPERIMENTAL: IDeg M	Drug: insulin degludec; Single dose of NN1250, formulation 1, 0.4U/kg body weight injected subcutaneously (under the skin); Drug: insulin degludec; Single dose of NN1250, formulation 2, 0.4U/kg body weight injected subcutaneously (under the skin)

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
Area under the Insulin Degludec concentration-time curve from 0 to 120 hours after single dose	From 0 to 120 hours after dosing
Maximum observed Insulin Degludec concentration after single dose	From 0 to 120 hours after dosing

Secondary Outcome Measures

Outcome Measure	Time Frame
Time to maximum observed Insulin Degludec concentration after single dose	From 0 to 120 hours after dosing
Area under the Insulin Degludec concentration-time curve from 0 to 24 hours after single dose	From 0-24 hours after dosing
Terminal half-life for Insulin Degludec	From 0 to 120 hours after dosing

Collaborators and Investigators

• Sponsor: Novo Nordisk A/S

Publications and helpful links

Helpful Links

• Clinical Trials at Novo Nordisk

Study record dates

Study Major Dates

• Study Start: August 1, 2009
• Primary Completion (ACTUAL): October 1, 2009
• Study Completion (ACTUAL): October 1, 2009

Study Registration Dates

• First Submitted: August 25, 2009
• First Submitted That Met QC Criteria: August 25, 2009
• First Posted (ESTIMATE): August 26, 2009

Study Record Updates

• Last Update Posted (ESTIMATE): September 28, 2015
• Last Update Submitted That Met QC Criteria: September 24, 2015
• Last Verified: September 1, 2015

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Hypoglycemic Agents; Physiological Effects of Drugs; Insulin; Insulin, Globin Zinc; Insulin, Long-Acting
• Other Study ID Numbers: NN1250-1988; P/44/2010 (OTHER: EMA (PDCO)); U1111-1122-2992 (OTHER: WHO); 2011-002949-35 (EUDRACT_NUMBER); P/96/2011 (OTHER: EMA (PDCO))