Safety, Pharmacokinetics and Pharmacodynamics of Two IDegAsp (One Explorative) Preparations and Two Insulin Degludec (One Explorative) Preparations in Japanese Subjects

Healthy Clinical Trial

Official title:

A Randomised, Double-blind, Single Centre, Placebocontrolled, Parallel Group, Multiple s.c. Dose Trial to Assess the Safety, Pharmacokinetics and Pharmacodynamics of Two SIAC Preparations and Two Insulin 454 (SIBA) Preparations in Healthy Japanese Male Subjects

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01868555
• Other study ID #: NN5401-1790
• Status: Completed
• Phase: Phase 1
• First received: May 30, 2013
• Last updated: October 21, 2015
• Start date: December 2007
• Est. completion date: February 2008

Study information

• Verified date: October 2015
• Source: Novo Nordisk A/S
• Contact: n/a
• Is FDA regulated: No
• Health authority: Japan: Ministry of Health, Labor and Welfare
• Study type: Interventional

Clinical Trial Summary

This trial is conducted in Asia. The aim of this trial is to assess the safety, pharmacokinetics (the exposure of the trial drug in the body) and pharmacodynamics (the effect of the investigated drug on the body) of two insulin degludec/insulin aspart (IDegAsp) preparations and two insulin degludec (insulin 454) preparations in healthy Japanese male subjects. IDegAsp 45 (B) and insulin degludec (B) are explorative formulations, not similar to the proposed commercial formulations.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 32
• Est. completion date: February 2008
• Est. primary completion date: February 2008
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Male
• Age group: 20 Years to 45 Years

Eligibility

Inclusion Criteria:

• Healthy Japanese male subjects

• Body mass index (BMI) between 18.0 and 27.0 kg/m^2 (both inclusive)

• Body weight above or equal to 50 kg

Exclusion Criteria:

• The receipt of any investigational drug within 16 weeks prior to this trial (the planned first dosing)

• Any clinical laboratory values deviated from the reference range at the laboratory (except for cases within physiological change) or any abnormal electrocardiogram (ECG) findings at the screening, as judged by the investigator or sub-investigator

• Known or suspected allergy to trial product(s) or related products

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
Administered as once daily subcutaneous (s.c., under the skin) dose per 0.6 nmol/kg body weight for 6 days
• insulin degludec/insulin aspart 30
Administered as once daily subcutaneous (s.c., under the skin) dose per 0.6 nmol/kg body weight for 6 days
• insulin degludec/insulin aspart 45
Administered as once daily subcutaneous (s.c., under the skin) dose per 0.6 nmol/kg body weight for 6 days
• placebo
Administered as once daily subcutaneous (s.c., under the skin) dose per 0.6 nmol/kg body weight for 6 days

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Novo Nordisk A/S

Country where clinical trial is conducted

Japan, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Adverse events (AEs)		Day 1-6 and 7-28 days after day 6	No
Secondary	Area under the serum insulin 454 concentration curve		0-96 hours after last dosing	No
Secondary	Area under the serum insulin aspart concentration curve		0-6 hours after dosing	No

External Links

•   Clinical Trials at Novo Nordisk