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

Healthy Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01865331
• Other study ID #: NN5401-1788
• Secondary ID: 2006-002615-26
• Status: Completed
• Phase: Phase 1
• First received: May 27, 2013
• Last updated: January 14, 2016
• Start date: December 2006
• Est. completion date: March 2007

Study information

• Verified date: January 2016
• 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 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 32
• Est. completion date: March 2007
• Est. primary completion date: March 2007
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Male
• Age group: 18 Years to 55 Years

Eligibility

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

Study Design

Allocation: Randomized, Endpoint Classification: Pharmacokinetics/Dynamics Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Diabetes
• Healthy

Intervention

Drug:
• insulin degludec
Single dose administered subcutaneously (s.c., under the skin).
• placebo
Administered subcutaneously (s.c., under the skin)
• insulin degludec/insulin aspart 50
Single dose of IDegAsp 50 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	Frequency of adverse events (AEs)		From dosing visit and until follow-up 7-21 days after last dosing visit	No
Secondary	Area under the serum insulin concentration curve		0-96 hours after dosing	No
Secondary	Area under the glucose infusion rate curve		0-24 hours after dosing	No

External Links

•   Clinical Trials at Novo Nordisk