NCT00318786

Brief Summary

This trial is conducted in Japan. This a clinical trial to study the efficacy and safety of three times a day BIAsp-70 compared to two times a day BIAsp-30 in subjects with type 2 diabetes.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
289

participants targeted

Target at P25-P50 for phase_3 diabetes

Timeline
Completed

Started Apr 2006

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, 2006

Completed
25 days until next milestone

First Submitted

Initial submission to the registry

April 26, 2006

Completed
1 day until next milestone

First Posted

Study publicly available on registry

April 27, 2006

Completed
1.1 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 1, 2007

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

June 1, 2007

Completed
Last Updated

January 6, 2017

Status Verified

January 1, 2017

Enrollment Period

1.2 years

First QC Date

April 26, 2006

Last Update Submit

January 5, 2017

Conditions

DiabetesDiabetes Mellitus, Type 2

Outcome Measures

Primary Outcomes (1)

  • Hemoglobin A1C (HbA1C)

    After 16 weeks of treatment

Secondary Outcomes (1)

  • HbA1C, after 28 weeks of treatment; Plasma glucose levels

Interventions

biphasic insulin aspartDRUG

Eligibility Criteria

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

You may qualify if:

  • Subjects with type 2 diabetes
  • Current treatment using intermediate-acting, long-acting insulin (including long-acting insulin analogue) or pre-mixed human insulin for at least 24 weeks
  • HbA1c at least 7.5% and below 10.0%

You may not qualify if:

  • Proliferative retinopathy or maculopathy requiring acute treatment
  • Impaired hepatic and/or renal function
  • Cardiac diseases
  • Uncontrolled hypertension
  • Known hypoglycemia unawareness or recurrent major hypoglycemia

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Novo Nordisk Investigational Site

Tokyo, 1000005, Japan

Location

Related Publications (1)

  • Kadowaki T, Nishida T, Kaku K. 28-week, randomized, multicenter, open-label, parallel-group phase III trial to investigate the efficacy and safety of biphasic insulin aspart 70 thrice-daily injections vs twice-daily injections of biphasic insulin aspart 30 in patients with type 2 diabetes. J Diabetes Investig. 2010 Jun 1;1(3):103-10. doi: 10.1111/j.2040-1124.2010.00015.x.

    PMID: 24843416RESULT

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

Study Record Dates

First Submitted

April 26, 2006

First Posted

April 27, 2006

Study Start

April 1, 2006

Primary Completion

June 1, 2007

Study Completion

June 1, 2007

Last Updated

January 6, 2017

Record last verified: 2017-01

Locations

JP(1)