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

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

Status

Completed

Phases

Phase 3

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT00476437

Enrollment

Registered

2007-05-22

Start date

2007-04-30

Completion date

2007-11-30

Last updated

2023-11-02

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Diabetes, Diabetes Mellitus, Type 2

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.

Interventions

DRUGbiphasic insulin aspart

DRUGbiphasic human insulin

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Masking

NONE

Eligibility

Sex/Gender

ALL

Age

20 Years to No maximum

Healthy volunteers

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.)

Design outcomes

Primary

Measure	Time frame
Incidence of hypoglycaemic episodes	During 16 weeks of treatment

Countries

Japan

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Mar 9, 2026