NCT00476437

Brief Summary

This trial is conducted in Japan. The purpose of this trial is to investigate the safety and the effect of biphasic insulin aspart 50 compared to biphasic human insulin 50 in patients with type 2 diabetes mellitus.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
81

participants targeted

Target at below P25 for phase_3 diabetes

Timeline
Completed

Started Apr 2007

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

April 1, 2007

Completed
2 months until next milestone

First Submitted

Initial submission to the registry

May 21, 2007

Completed
1 day until next milestone

First Posted

Study publicly available on registry

May 22, 2007

Completed
5 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 1, 2007

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

November 1, 2007

Completed
Last Updated

November 2, 2023

Status Verified

October 1, 2023

Enrollment Period

7 months

First QC Date

May 21, 2007

Last Update Submit

October 31, 2023

Conditions

DiabetesDiabetes Mellitus, Type 2

Outcome Measures

Primary Outcomes (1)

  • Incidence of hypoglycaemic episodes

    During 16 weeks of treatment

Interventions

biphasic insulin aspartDRUG
biphasic human insulinDRUG

Eligibility Criteria

Age20 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Type 2 diabetes mellitus
  • Current treatment with pre-mixed human insulin preparation or biphasic/pre-mixed insulin analogue in twice daily treatment for at least 8 weeks.
  • HbA1C: less than 11.0%
  • BMI: less than 30.0 kg/m2

You may not qualify if:

  • Total daily insulin dose: 100 IU/U and more
  • Treatment with oral hypoglycaemic agents within the last 4 weeks.
  • Treatment with insulin sensitizer within the last 12 weeks
  • A lifestyle that is considered unsuitable for this trial (frequent or routine night shift workers etc.)

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Unknown Facility

Tokyo, 1000005, Japan

Location

Related Links

MeSH Terms

Conditions

Diabetes MellitusDiabetes Mellitus, Type 2

Interventions

insulin aspart, insulin aspart protamine drug combination 30:70biphasic human insulin 30

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
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

May 21, 2007

First Posted

May 22, 2007

Study Start

April 1, 2007

Primary Completion

November 1, 2007

Study Completion

November 1, 2007

Last Updated

November 2, 2023

Record last verified: 2023-10

Locations

JP(1)