Skip to main content
OpenTrials
Completed

NCT Number: NCT01868581

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

Completed

Looking for future studies?

Notify Me

Key information

Conditions

Diabetes Diabetes Mellitus Endocrine System Diseases Glucose Metabolism Disorders Healthy Metabolic Diseases Nutritional and Metabolic Diseases

Age range

18 year–55 year

Sex eligibility

Male

Study type

Interventional

Phase

Phase 1

Primary location

Neuss, 41460, Germany

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

insulin degludec

Drug

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

Drug

Each subject will be allocated to 2 single injections of trial product on 2 separate dosing visits, administered subcutaneously (s.c., under the skin).

Primary outcomes

  1. Area under the serum insulin degludec concentration-time curve (for insulin degludec)

    Time frame: 0-120 hours after dosing

  2. Maximum serum insulin degludec concentration (Cmax) (for insulin degludec)

    Time frame: 0-120 hours after dosing

  3. Area under the serum insulin aspart concentration-time curve (for IDegAsp)

    Time frame: 0-10 hours after dosing

  4. Maximum serum insulin aspart concentration (Cmax) (for IDegAsp)

    Time frame: 0-10 hours after dosing

  5. Area under the serum insulin degludec concentration-time curve (for IDegAsp)

    Time frame: 0-120 hours after dosing

  6. Maximum serum insulin degludec concentration (Cmax) (for IDegAsp)

    Time frame: 0-120 hours after dosing

Sponsors and collaborators

Lead sponsor

Novo Nordisk A/S

Industry

Registry information

Official study 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

Important dates

Study start
2008
Primary completion
2008
Study completion
2008
First posted
Jun 4, 2013
Registry last updated
Oct 26, 2015

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Related clinical trials

Published trials that share one or more normalized conditions with this study.