Bioequivalence Between Two Explorative Insulin Degludec Formulations and Between Two Explorative IDegAsp Formulations in Healthy Subjects

A Randomised, Single Centre, Double-blind, Two-period Crossover, Glucose Clamp Trial to Test for Bioequivalence Between Two Insulin 454 Formulations, With or Without Buffer, and Between Two SIAC Formulations, With or Without Buffer, in Healthy Male Subjects

This trial is conducted i Europe. The aim of this trial is to test for bioequivalence between two explorative formulations of insulin degludec (insulin 454) and between two explorative insulin degludec/insulin aspart (IDegAsp - formerly SIAC) formulations, all with or without buffer, in healthy male subjects. The investigated formulations are explorative, not similar to the proposed commercial formulation.

Study Overview

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

• Study Type: Interventional
• Enrollment (Actual): 58
• Phase: Phase 1

Contacts and Locations

Study Locations

• Germany
  • Neuss, Germany, 41460

Participation Criteria

Eligibility Criteria

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

Description

Inclusion Criteria:

• Informed consent obtained before any trial-related activities. Trial related activities are any procedure that would not have been performed during the normal management of the subject
• Considered generally healthy upon completion of medical history and physical examination as judged by the Investigator
• Body mass index (BMI) between 18.0 and 27.0 kg/m^2 (inclusive)
• Fasting plasma glucose below or equal to 6 mmol/L
• Sexually active and non-sterilised participants must be informed that they and their partner must use a safe method of contraception during sexual intercourse (risk of pregnancy must be lower than 1%), e.g. implants, injections, combined oral contraceptives or hormonal intrauterinedevice or be willing to refrain from having sexual intercourse from the beginning of the study until up to three months after the conclusion of the study. This serves to exclude the possibilityof a pregnancy through sperm that could have been damaged by the study medication

Exclusion Criteria:

• A history of any illness that, in the opinion of the investigator, might confound the results of the trial or pose risk in administering the trial product to the subject
• Known or suspected allergy to trial products or related products
• Subject who has participated in any other trials involving investigational products within the last 3 months prior to first dosing

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Crossover Assignment
• Masking: Double

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: IDegAsp	Drug: insulin degludec/insulin aspart; Each subject will be allocated to 2 single injections of trial product on 2 separate dosing visits, administered subcutaneously (s.c., under the skin).
Experimental: insulin degludec	Drug: insulin degludec; Each subject will be allocated to 2 single injections of trial product on 2 separate dosing visits, administered subcutaneously (s.c., under the skin).

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
Area under the serum insulin degludec concentration-time curve (for insulin degludec)	0-120 hours after dosing
Maximum serum insulin degludec concentration (Cmax) (for insulin degludec)	0-120 hours after dosing
Area under the serum insulin aspart concentration-time curve (for IDegAsp)	0-10 hours after dosing
Maximum serum insulin aspart concentration (Cmax) (for IDegAsp)	0-10 hours after dosing
Area under the serum insulin degludec concentration-time curve (for IDegAsp)	0-120 hours after dosing
Maximum serum insulin degludec concentration (Cmax) (for IDegAsp)	0-120 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: May 1, 2008
• Primary Completion (Actual): August 1, 2008
• Study Completion (Actual): August 1, 2008

Study Registration Dates

• First Submitted: May 30, 2013
• First Submitted That Met QC Criteria: May 30, 2013
• First Posted (Estimate): June 4, 2013

Study Record Updates

• Last Update Posted (Estimate): October 26, 2015
• Last Update Submitted That Met QC Criteria: October 23, 2015
• Last Verified: October 1, 2015

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Hypoglycemic Agents; Physiological Effects of Drugs; Insulin; Insulin, Globin Zinc; Insulin Aspart; Insulin, Long-Acting
• Other Study ID Numbers: NN5401-1985; 2008-000097-20 (EudraCT Number)