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

A Randomised, Double-blind, Placebo-controlled, Single-dose, Parallel Group Trial With Insulin 454 and SIAM 50 in Healthy Male Japanese Subjects

Status

Completed

Phases

Phase 1

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT01865331

Enrollment

Registered

2013-05-30

Start date

2006-12-31

Completion date

2007-03-31

Last updated

2016-01-15

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Diabetes, Healthy

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.

Interventions

DRUGinsulin degludec

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

DRUGplacebo

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

DRUGinsulin degludec/insulin aspart 50

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

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Masking

DOUBLE (Subject, Investigator)

Eligibility

Sex/Gender

MALE

Age

18 Years to 55 Years

Healthy volunteers

Yes

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

Design outcomes

Primary

Measure	Time frame
Frequency of adverse events (AEs)	From dosing visit and until follow-up 7-21 days after last dosing visit

Secondary

Measure	Time frame
Area under the serum insulin concentration curve	0-96 hours after dosing
Area under the glucose infusion rate curve	0-24 hours after dosing

Countries

Germany

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026