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

Phase 1

Completed

• Conditions: Diabetes; Healthy
• Interventions: Drug: insulin degludec/insulin aspart 30; Drug: insulin degludec; Drug: insulin degludec/insulin aspart 45; Drug: placebo

• Registration Number: NCT01868555
• Lead Sponsor: Novo Nordisk A/S

Brief 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.

Detailed Description

Not available

Study Timeline

• Study Start: 2007-12
• Primary Completion: 2008-02
• Study Completion: 2008-02
• Study First Submitted: 2013-05-30
• Study First Submitted QC: 2013-05-30
• Study First Posted: 2013-06-04
• Status Verified: 2015-10
• Last Update Submitted: 2015-10-21
• Last Update Posted: 2015-10-22

Recruitment & Eligibility

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

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

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
insulin degludec (B)	placebo	-
insulin degludec (E)	placebo	-
IDegAsp 30	insulin degludec/insulin aspart 30	-
insulin degludec (B)	insulin degludec	-
IDegAsp 45	placebo	-
insulin degludec (E)	insulin degludec	-
IDegAsp 45	insulin degludec/insulin aspart 45	-
IDegAsp 30	placebo	-

Primary Outcome Measures

Name	Time	Method
Adverse events (AEs)	Day 1-6 and 7-28 days after day 6

Secondary Outcome Measures

Name	Time	Method
Area under the serum insulin 454 concentration curve	0-96 hours after last dosing
Area under the serum insulin aspart concentration curve	0-6 hours after dosing