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

NCT01865331 | Completed Phase 1

• 2 other identifiers: NN5401-17882006-002615-26
• Study Type: interventional
• Target: 32
• Locations: 1 country
• Sites: 1

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

Outcome Measures

Primary Outcomes (1)

• Frequency of adverse events (AEs)

  From dosing visit and until follow-up 7-21 days after last dosing visit

Secondary Outcomes (2)

• Area under the serum insulin concentration curve

  0-96 hours after dosing

• Area under the glucose infusion rate curve

  0-24 hours after dosing

Study Arms (4)

Low dose, insulin degludec

EXPERIMENTAL

Drug: insulin degludec; Drug: placebo

Medium dose, insulin degludec

EXPERIMENTAL

Drug: insulin degludec; Drug: placebo

High dose, insulin degludec

EXPERIMENTAL

Drug: insulin degludec; Drug: placebo

IDegAsp 50

EXPERIMENTAL

Drug: placebo; Drug: insulin degludec/insulin aspart 50

Interventions

insulin degludec DRUG

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

High dose, insulin degludec; Low dose, insulin degludec; Medium dose, insulin degludec

placebo DRUG

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

High dose, insulin degludec; IDegAsp 50; Low dose, insulin degludec; Medium dose, insulin degludec

insulin degludec/insulin aspart 50 DRUG

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

IDegAsp 50

Eligibility Criteria

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

You may qualify if:

• 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

You may not qualify if:

• 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

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

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: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 27, 2013
• First Posted: May 30, 2013
• Study Start: December 1, 2006
• Primary Completion: March 1, 2007
• Study Completion: March 1, 2007
• Last Updated: January 15, 2016

Record last verified: 2016-01

Locations

DE (1)