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NCT00476437 Clinical Trial

Safety and Effect of Biphasic Insulin Aspart 50 in Patients With Type 2 Diabetes Mellitus.

Diabetes Mellitus, Type 2 Clinical Trial

Official title:
Safety and Effect of Biphasic Insulin Aspart 50 Compared to Biphasic Human Insulin 50 in Patients With Type 2 Diabetes Mellitus.

Clinical Trial Details — Status: Completed

Administrative data
NCT number NCT00476437
Other study ID # BIASP-1864
Secondary ID JapicCTI-070408
Status Completed
Phase Phase 3
First received
Last updated
Start date April 2007
Est. completion date November 2007

Study information
Verified date October 2023
Source Novo Nordisk A/S
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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.

Recruitment information / eligibility
Status Completed
Enrollment 81
Est. completion date November 2007
Est. primary completion date November 2007
Accepts healthy volunteers No
Gender All
Age group 20 Years and older
Eligibility Inclusion Criteria: - 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 Exclusion Criteria: - 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.)

Study Design

Related Conditions & MeSH terms

Intervention

Drug:
• biphasic insulin aspart

• biphasic human insulin

Locations
Country Name City State
n/a

Sponsors (1)
Lead Sponsor Collaborator
Novo Nordisk A/S

Country where clinical trial is conducted

Japan, 

Outcome
Type Measure Description Time frame Safety issue
Primary Incidence of hypoglycaemic episodes During 16 weeks of treatment
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