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

NCT01868581 | Completed Phase 1

• 2 other identifiers: NN5401-19852008-000097-20
• Study Type: interventional
• Target: 58
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Diabetes; Healthy

Outcome Measures

Primary Outcomes (6)

• 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

Study Arms (2)

insulin degludec

EXPERIMENTAL

Drug: insulin degludec

IDegAsp

EXPERIMENTAL

Drug: insulin degludec/insulin aspart

Interventions

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 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).

IDegAsp

Eligibility Criteria

• Age: 18 Years - 55 Years
• Sex: male
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Novo Nordisk A/S: lead

Study Sites (1)

Unknown Facility

Neuss, 41460, Germany

Location

Related Links

• Clinical Trials at Novo Nordisk

MeSH Terms

Conditions

Diabetes Mellitus

Interventions

insulin degludec; insulin degludec, insulin aspart drug combination

Condition Hierarchy (Ancestors)

Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases; Endocrine System Diseases

Study Officials

• Global Clinical Registry (GCR, 1452)

  Novo Nordisk A/S

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: CROSSOVER
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 30, 2013
• First Posted: June 4, 2013
• Study Start: May 1, 2008
• Primary Completion: August 1, 2008
• Study Completion: August 1, 2008
• Last Updated: October 26, 2015

Record last verified: 2015-10

Locations

DE (1)