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

Phase 3

Completed

• Conditions: Diabetes; Diabetes Mellitus, Type 2

• Registration Number: NCT00476437
• Lead Sponsor: Novo Nordisk A/S

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2007-04
• Study First Submitted: 2007-05-21
• Study First Submitted QC: 2007-05-21
• Study First Posted: 2007-05-22
• Primary Completion: 2007-11
• Study Completion: 2007-11
• Status Verified: 2023-10
• Last Update Submitted: 2023-10-31
• Last Update Posted: 2023-11-02

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 81

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

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Primary Outcome Measures

Name	Time	Method
Incidence of hypoglycaemic episodes	During 16 weeks of treatment