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CompletedNCT01620450Updated Mar 1, 2017

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

A Phase 1 interventional study of biphasic human insulin 30 in Diabetes and Healthy, sponsored by Novo Nordisk A/S. Completed at 1 site in Japan. Open to male participants aged 18 Years to 50 Years. Per ClinicalTrials.gov, last updated 2017-03-01.

Sponsored by Novo Nordisk A/S · Phase 1, Interventional, and Treatment

From the registry’s dates

  • Registered 7 years 6 months after the study started (first participant enrolled Nov 2004, registered Jun 2012).
Phase
Phase 1
Study type
Interventional
Enrollment
34
Allocation
Randomized
Ages
18 Years to 50 Years
Sex
Male
01

Study 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.

02

Conditions studied

  • Diabetes
  • Healthy
03

In context

Lead sponsor

Novo Nordisk A/S is the lead sponsor of 1,370 studies on the registry; 102 are open to participants now.

Of its 198 completed or terminated interventional studies of FDA-regulated products, 94 (47%) have results posted.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years to 50 Years
Sexes eligible
Male
Accepts healthy volunteers
No

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

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
05

Study design

Phase
Phase 1
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Crossover assignment
Masking
Double (Participant, Investigator)
Enrollment
34 participants (actual)

Study arms

  • Experimental
    NN2000

    Drug: biphasic human insulin 30

  • Active comparator
    NN-X14

    Drug: biphasic human insulin 30

Interventions

  • Drugbiphasic human insulin 30

    Single dose of each formulation administered subcutaneously (s.c., under the skin) on two separate visits

06

What researchers measure

Primary outcomes

  1. Area under the curve of insulin aspart concentration (AUC IAsp, 0-16h)

    Time frame: From 0 to 16 hours after injection

  2. Maximum insulin aspart concentration (Cmax IAsp)

Secondary outcomes

  1. Area under the curve of insulin aspart concentration (AUC IAsp)

  2. Time to maximum insulin aspart concentration (tmax IAsp)

  3. Terminal elimination half life (t½)

  4. Body weight

  5. Adverse events

07

Study locations

1 site
  • Novo Nordisk Investigational Site
    Tokyo, 1000005, Japan
08

References and documents

09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Mar 1, 2017, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT01620450
Lead sponsor
Novo Nordisk A/S
Responsible party
Sponsor
First posted
Jun 15, 2012
Start date
Nov 20, 2004
Primary completion
Feb 26, 2005
Completion
Feb 26, 2005
Last update
Mar 1, 2017

Study contacts

Global Clinical Registry (GCR, 1452)
study director · Novo Nordisk A/S

Oversight

Data monitoring committee
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Feb 2017. You cannot join it, but the record below documents what was studied.

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