Comparison of Biphasic Insulin Aspart Produced by the NN2000 Process to Current Process to in Type 2 Diabetes

Novo Nordisk A/S126 enrolled

Overview

This trial is conducted in Japan. The aim of this trial was to investigate the safety and efficacy of NN2000-Mix30 produced by NN2000 process compared to that of NN-X14Mix30 produced by current process in Japanese subjects with type 2 diabetes.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

DOUBLE

Enrollment

126

Conditions

Diabetes Diabetes Mellitus, Type 2

Interventions

biphasic insulin aspartDRUG

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

Inclusion Criteria: * Subjects with type 2 diabetes * Subjects with insulin treatment for at least 24 weeks * Current treatment with premixed biphasic human insulin preparation for at least 12 weeks * HbA1c lesser than or equal to 11.0% Exclusion Criteria: * Recurrent severe hypoglycaemia * Proliferative retinopathy or maculopathy requiring acute treatment * Impaired renal function * Cardiac diseases * Uncontrolled hypertension * Subjects with known malignant tumour * Total daily insulin dose greater than or equal to 100 IU

Locations (1)

Novo Nordisk Investigational Site

Tokyo, Japan

Outcomes

Primary Outcomes

Safety

Time frame: During 24 weeks of treatment

Secondary Outcomes

HbA1c

Data from ClinicalTrials.gov

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