Safety, Tolerability and Pharmacokinetic and Pharmacodynamic Characteristics of Explorative Formulations of Insulin Degludec and IDegAsp 50 in Healthy Japanese Subjects

NCT ID: NCT01865331

Last Updated: 2016-01-15

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE1
• Total Enrollment: 32 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2006-12-31
• Study Completion Date: 2007-03-31

Brief Summary

This trial is conducted in Europe. The aim of this trial is to investigate safety, tolerability and pharmacokinetic (the exposure of the trial drug in the body) and pharmacodynamic (the effect of the investigated drug on the body) characteristics of insulin degludec (insulin 454) and insulin degludec/insulin aspart (IDegAsp) 50 - formerly SIAM), both explorative formulations, not similar to the proposed commercial formulation, in healthy male Japanese subjects.

Conditions

Diabetes; Healthy

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: DOUBLE

Study Groups

Low dose, insulin degludec

Group Type: EXPERIMENTAL

insulin degludec

Intervention Type: DRUG

Single dose administered subcutaneously (s.c., under the skin).

placebo

Intervention Type: DRUG

Administered subcutaneously (s.c., under the skin)

Medium dose, insulin degludec

Group Type: EXPERIMENTAL

insulin degludec

Intervention Type: DRUG

Single dose administered subcutaneously (s.c., under the skin).

placebo

Intervention Type: DRUG

Administered subcutaneously (s.c., under the skin)

High dose, insulin degludec

Group Type: EXPERIMENTAL

insulin degludec

Intervention Type: DRUG

Single dose administered subcutaneously (s.c., under the skin).

placebo

Intervention Type: DRUG

Administered subcutaneously (s.c., under the skin)

IDegAsp 50

Group Type: EXPERIMENTAL

placebo

Intervention Type: DRUG

Administered subcutaneously (s.c., under the skin)

insulin degludec/insulin aspart 50

Intervention Type: DRUG

Single dose of IDegAsp 50 administered subcutaneously (s.c., under the skin)

Interventions

insulin degludec

Single dose administered subcutaneously (s.c., under the skin).

Intervention Type: DRUG

placebo

Administered subcutaneously (s.c., under the skin)

Intervention Type: DRUG

insulin degludec/insulin aspart 50

Single dose of IDegAsp 50 administered subcutaneously (s.c., under the skin)

Intervention Type: DRUG

Eligibility Criteria

Inclusion Criteria

• Japanese passport holder
• Japanese-born parents
• Body mass index (BMI) between 18.0 and 27.0 kg/m^2 (both inclusive)
• Fasting blood glucose of below or equal to 6 mmol/L
• Healthy male subjects, who are considered to be generally healthy based on an assessment of medical history, physical examination and clinical laboratory data at screening, as assessment of medical history, physical exjudged by the Investigator

Exclusion Criteria

• The receipt of any investigational drug within 3 months prior to this trial
• Subjects with a history of significant multiple drug allergies or with a known allergy to the trialproduct or any medicine chemically related to the trial product, as judged by the Investigator

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 55 Years
• Eligible Sex: MALE
• Accepts Healthy Volunteers: Yes

Sponsors

Novo Nordisk A/S

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Global Clinical Registry (GCR, 1452)

Role: STUDY_DIRECTOR

Novo Nordisk A/S

Locations

Neuss, , Germany

Countries

Germany

Related Links

http://novonordisk-trials.com

Clinical Trials at Novo Nordisk

Other Identifiers

2006-002615-26

Identifier Type: EUDRACT_NUMBER

Identifier Source: secondary_id

NN5401-1788

Identifier Type: -

Identifier Source: org_study_id