NCT00564668

Brief Summary

This trial is conducted in Japan. The aim of this trial was to investigate the safety and efficacy of NN2000-Mix30 produced by NN2000 process compared to that of NN-X14Mix30 produced by current process in Japanese subjects with type 2 diabetes.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
126

participants targeted

Target at below P25 for phase_3 diabetes

Timeline
Completed

Started Jun 2004

Shorter than P25 for phase_3 diabetes

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

June 19, 2004

Completed
10 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 12, 2005

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

April 12, 2005

Completed
2.6 years until next milestone

First Submitted

Initial submission to the registry

November 27, 2007

Completed
1 day until next milestone

First Posted

Study publicly available on registry

November 28, 2007

Completed
Last Updated

March 1, 2017

Status Verified

February 1, 2017

Enrollment Period

10 months

First QC Date

November 27, 2007

Last Update Submit

February 28, 2017

Conditions

DiabetesDiabetes Mellitus, Type 2

Outcome Measures

Primary Outcomes (1)

  • Safety

    During 24 weeks of treatment

Secondary Outcomes (1)

  • HbA1c

Interventions

biphasic insulin aspartDRUG

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Subjects with type 2 diabetes
  • Subjects with insulin treatment for at least 24 weeks
  • Current treatment with premixed biphasic human insulin preparation for at least 12 weeks
  • HbA1c lesser than or equal to 11.0%

You may not qualify if:

  • Recurrent severe hypoglycaemia
  • Proliferative retinopathy or maculopathy requiring acute treatment
  • Impaired renal function
  • Cardiac diseases
  • Uncontrolled hypertension
  • Subjects with known malignant tumour
  • Total daily insulin dose greater than or equal to 100 IU

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Novo Nordisk Investigational Site

Tokyo, 1000005, Japan

Location

Related Links

MeSH Terms

Conditions

Diabetes MellitusDiabetes Mellitus, Type 2

Interventions

insulin aspart, insulin aspart protamine drug combination 30:70

Condition Hierarchy (Ancestors)

Glucose Metabolism DisordersMetabolic DiseasesNutritional and Metabolic DiseasesEndocrine System Diseases

Study Officials

  • Global Clinical Registry (GCR, 1452)

    Novo Nordisk A/S

    STUDY DIRECTOR

Study Design

Study Type
interventional
Phase
phase 3
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, INVESTIGATOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

November 27, 2007

First Posted

November 28, 2007

Study Start

June 19, 2004

Primary Completion

April 12, 2005

Study Completion

April 12, 2005

Last Updated

March 1, 2017

Record last verified: 2017-02

Locations

JP(1)