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

Efficacy and Safety of Initiation of Biphasic Insulin Aspart 30 Treatment in Subjects With Type 2 Diabetes Mellitus Failing OAD Therapy

Status

Completed

Phases

Phase 4

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT00605111

Enrollment

193

Registered

2008-01-30

Start date

2003-12-31

Completion date

2004-10-31

Last updated

2017-01-11

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 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.

Interventions

DRUGbiphasic insulin aspart

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Masking

NONE

Eligibility

Sex/Gender

ALL

Age

18 Years to No maximum

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

Design outcomes

Primary

Measure	Time frame
HbA1c	after 11 weeks of treatment

Secondary

Measure	Time frame
The proportion of subjects achieving treatment target of HbA1c below 7%	at 11 and 24 weeks
8-point plasma glucose profiles	performed at 11 and 24 weeks
FPG	at 11 weeks and 24 weeks

Countries

Australia, Hong Kong, Malaysia, Philippines, Singapore, Taiwan, Thailand

Outcome results

None listed

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