Efficacy and Safety of Biphasic Insulin Aspart 30 in Subjects With Type 2 Diabetes

Novo Nordisk A/S193 enrolled

Overview

This trial is conducted in Asia. The aim of this trial is to investigate the efficacy and safety of biphasic insulin aspart 30 as start insulin in subjects with type 2 diabetes failing OAD therapy.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

NONE

Enrollment

193

Conditions

Diabetes Diabetes Mellitus, Type 2

Interventions

biphasic insulin aspartDRUG

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

Inclusion Criteria: * Type 2 diabetes for at least 24 months * BMI between 18 and 30 kg/m2 * Insulin naive subjects * OAD treatment with max two OADs alone or combined with other therapy * HbA1c between 7-12% Exclusion Criteria: * Type 1 diabetes * Receipt of any investigational drug within the last three months prior to this trial * Current or previous treatment with thiazolidiones within the last 6 months * OAD treatment with three or more OADs within the last 4 months

Locations (17)

Novo Nordisk Investigational Site

Blacktown, New South Wales, Australia

Novo Nordisk Investigational Site

Broadmeadow, New South Wales, Australia

Outcomes

Primary Outcomes

HbA1c

Time frame: after 11 weeks of treatment

Secondary Outcomes

The proportion of subjects achieving treatment target of HbA1c below 7%

Time frame: at 11 and 24 weeks

8-point plasma glucose profiles

Time frame: performed at 11 and 24 weeks

FPG

Time frame: at 11 weeks and 24 weeks

Data from ClinicalTrials.gov

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