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

Healthy Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01868581
• Other study ID #: NN5401-1985
• Secondary ID: 2008-000097-20
• Status: Completed
• Phase: Phase 1
• First received: May 30, 2013
• Last updated: October 23, 2015
• Start date: May 2008
• Est. completion date: August 2008

Study information

• Verified date: October 2015
• Source: Novo Nordisk A/S
• Contact: n/a
• Is FDA regulated: No
• Health authority: Germany: Federal Institute for Drugs and Medical Devices
• Study type: Interventional

Clinical Trial Summary

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 58
• Est. completion date: August 2008
• Est. primary completion date: August 2008
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Male
• Age group: 18 Years to 55 Years

Eligibility

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 Design

Allocation: Randomized, Endpoint Classification: Bio-equivalence Study, Intervention Model: Crossover Assignment, Masking: Double Blind (Subject, Investigator), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Diabetes
• Healthy

Intervention

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).
• 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).

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Novo Nordisk A/S

Country where clinical trial is conducted

Germany, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Area under the serum insulin degludec concentration-time curve (for insulin degludec)		0-120 hours after dosing	No
Primary	Maximum serum insulin degludec concentration (Cmax) (for insulin degludec)		0-120 hours after dosing	No
Primary	Area under the serum insulin aspart concentration-time curve (for IDegAsp)		0-10 hours after dosing	No
Primary	Maximum serum insulin aspart concentration (Cmax) (for IDegAsp)		0-10 hours after dosing	No
Primary	Area under the serum insulin degludec concentration-time curve (for IDegAsp)		0-120 hours after dosing	No
Primary	Maximum serum insulin degludec concentration (Cmax) (for IDegAsp)		0-120 hours after dosing	No

External Links

•   Clinical Trials at Novo Nordisk