Comparison of Insulin Aspart Produced by Current Process and the NN2000 Process in Healthy Japanese

Phase 1

Completed

• Conditions: Diabetes; Healthy
• Interventions: Drug: biphasic human insulin 30

• Registration Number: NCT01620450
• Lead Sponsor: Novo Nordisk A/S

Brief Summary

This trial is conducted in Japan. The aim of this trial is to compare insulin aspart produced by current process and the NN2000 process in healthy Japanese subjects.

Detailed Description

Not available

Study Timeline

• Study Start: 2004-11-20
• Primary Completion: 2005-02-26
• Study Completion: 2005-02-26
• Study First Submitted: 2012-06-13
• Study First Submitted QC: 2012-06-13
• Study First Posted: 2012-06-15
• Status Verified: 2017-02
• Last Update Submitted: 2017-02-28
• Last Update Posted: 2017-03-01

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Male
• Target Recruitment: 34

Inclusion Criteria

• Japanese
• Considered generally healthy based on medical history and physical examination
• Body Mass Index (BMI) between 18 and 27 kg/m^2 (both inclusive)
• Fasting plasma glucose between 3.8 mmol/L (68.4 mg/dL) and 6.0 mmol/L (108.0 mg/dL)

Exclusion Criteria

• Clinically significant abnormal values in clinical laboratory tests of haematology, biochemistry, fasting plasma glucose and urinalysis
• Any serious systemic infectious disease that occurred during the last 4 weeks before trial
• Any inter-current illness that may affect blood glucose
• Subject with a first degree relative with diabetes mellitus
• Blood donation of more than 400 mL (inclusive) in total within the last 12 weeks or more than 200 mL (inclusive) in total within the last 4 weeks

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: CROSSOVER

Arm && Interventions

Group	Intervention	Description
NN2000	biphasic human insulin 30	-
NN-X14	biphasic human insulin 30	-

Primary Outcome Measures

Name	Time	Method
Maximum insulin aspart concentration (Cmax IAsp)
Area under the curve of insulin aspart concentration (AUC IAsp, 0-16h)	From 0 to 16 hours after injection

Secondary Outcome Measures

Name	Time	Method
Area under the curve of insulin aspart concentration (AUC IAsp)
Time to maximum insulin aspart concentration (tmax IAsp)
Body weight
Adverse events
Terminal elimination half life (t½)

Trial Locations

Locations (1)

Novo Nordisk Investigational Site; 🇯🇵 Tokyo, Japan