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

Novo Nordisk A/S81 enrolled

Overview

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.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

NONE

Enrollment

Conditions

Diabetes Diabetes Mellitus, Type 2

Interventions

biphasic insulin aspartDRUG

biphasic human insulinDRUG

Eligibility

Sex: ALLMin age: 20 Years

Medical Language ↔ Plain English

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.)

Locations (1)

Unnamed facility

Tokyo, Japan

Outcomes

Primary Outcomes

Incidence of hypoglycaemic episodes

Time frame: During 16 weeks of treatment

Data from ClinicalTrials.gov

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