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

Phase 1

Completed

• Conditions: Diabetes; Healthy
• Interventions: Drug: insulin degludec; Drug: placebo; Drug: insulin degludec/insulin aspart 50

• Registration Number: NCT01865331
• Lead Sponsor: Novo Nordisk A/S

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2006-12
• Primary Completion: 2007-03
• Study Completion: 2007-03
• Study First Submitted: 2013-05-27
• Study First Submitted QC: 2013-05-27
• Study First Posted: 2013-05-30
• Status Verified: 2016-01
• Last Update Submitted: 2016-01-14
• Last Update Posted: 2016-01-15

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Male
• Target Recruitment: 32

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

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Low dose, insulin degludec	placebo	-
IDegAsp 50	insulin degludec/insulin aspart 50	-
Medium dose, insulin degludec	placebo	-
High dose, insulin degludec	placebo	-
IDegAsp 50	placebo	-
Low dose, insulin degludec	insulin degludec	-
High dose, insulin degludec	insulin degludec	-
Medium dose, insulin degludec	insulin degludec	-

Primary Outcome Measures

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

Secondary Outcome Measures

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