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

Novo Nordisk

Status and phase

Completed

Phase 4

Conditions

Diabetes

Diabetes Mellitus, Type 2

Treatments

Drug: biphasic insulin aspart

Study type

Interventional

Funder types

Industry

Identifiers

NCT00605111

BIASP-3021

Details and patient eligibility

About

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.

Enrollment

193 patients

Sex

All

Ages

18+ years old

Volunteers

No Healthy Volunteers

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