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

• Conditions: Healthy volunteers(Diabetes Mellitus, Type 1 and Diabetes Mellitus, Type 2); MedDRA version: 14.0Level: LLTClassification code 10045228Term: Type I diabetes mellitusSystem Organ Class: 10027433 - Metabolism and nutrition disorders; MedDRA version: 14.0Level: LLTClassification code 10045242Term: Type II diabetes mellitusSystem Organ Class: 10027433 - Metabolism and nutrition disorders; Therapeutic area: Diseases [C] - Nutritional and Metabolic Diseases [C18]

• Registration Number: EUCTR2011-002949-35-Outside-EU/EEA
• Lead Sponsor: ovo Nordisk A/S

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2011-11-01
• Last Update Posted: 19 March 2012

Recruitment & Eligibility

• Status: A
• Sex: All
• Target Recruitment: 26

Inclusion Criteria

• Male or female aged 18-55 years (both inclusive).
• Considered generally healthy upon completion of medical history, physical examination, vital signs and ECG, as judged by the Investigator.
• Body mass index 18.0-27.0 kg/m2 (both inclusive).
Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range 26
F.1.3 Elderly (>=65 years) no
F.1.3.1 Number of subjects for this age range

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 clinical trial of medicinal product
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Main Objective: The primary objective is to test for bioequivalence between two formulations of SIBA (IDeg) based on AUCI454,0-120h,SD and Cmax,I454,SD.;Secondary Objective: • to compare the pharmacokinetic and pharmacodynamic profiles of the two SIBA (IDeg) formulations<br>• to evaluate the short-term safety and tolerability of the two SIBA (IDeg) formulations;Primary end point(s): 1• AUCI454,0-120h,SD, area under the serum insulin 454 concentration-time curve from 0 to 120 hours after single-dose<br>2• Cmax,I454,SD, maximum observed serum insulin 454 concentration after single-dose (within 0 to 120 hours after dosing);Timepoint(s) of evaluation of this end point: • 0 to 120 hours after single-dose<br>

Secondary Outcome Measures

Name	Time	Method
Secondary end point(s): 1• tmax,I454,SD, time to maximum observed serum insulin 454 concentration after single-dose (within 0 to 120 hours after dosing)<br>2• AUCI454,0-24h,SD, area under the serum insulin 454 concentration-time curve from 0 to 24 hours after single-dose<br>3• t½,I454, terminal half-life for insulin 454 (within 0 to 120 hours after dosing);Timepoint(s) of evaluation of this end point: 1• 0 to 120 hours after dosing<br>2• 0 to 24 hours after single-dose<br>3• 0 to 120 hours after dosing