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

NCT ID: NCT00605111

Last Updated: 2017-01-11

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE4

Total Enrollment

193 participants

Study Classification

INTERVENTIONAL

Study Start Date

2003-12-31

Study Completion Date

2004-10-31

Brief Summary

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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.

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Detailed Description

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Conditions

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Diabetes Diabetes Mellitus, Type 2

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Interventions

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biphasic insulin aspart

Intervention Type DRUG

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Novo Nordisk A/S

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Global Clinical Registry (GCR, 1452)

Role: STUDY_DIRECTOR

Novo Nordisk A/S

Locations

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Novo Nordisk Investigational Site

Blacktown, New South Wales, Australia

Site Status

Novo Nordisk Investigational Site

Broadmeadow, New South Wales, Australia

Site Status

Novo Nordisk Investigational Site

Fitzroy, , Australia

Site Status

Novo Nordisk Investigational Site

Garran, , Australia

Site Status

Novo Nordisk Investigational Site

Stones Corner, , Australia

Site Status

Novo Nordisk Investigational Site

Hong Kong Island, , Hong Kong

Site Status

Novo Nordisk Investigational Site

Shatin, New Territories, , Hong Kong

Site Status

Novo Nordisk Investigational Site

Cheras, , Malaysia

Site Status

Novo Nordisk Investigational Site

Georgetown, Penang, , Malaysia

Site Status

Novo Nordisk Investigational Site

Kota Bharu, Kelantan, , Malaysia

Site Status

Novo Nordisk Investigational Site

Cebu City, , Philippines

Site Status

Novo Nordisk Investigational Site

Quezon City, , Philippines

Site Status

Novo Nordisk Investigational Site

Singapore, , Singapore

Site Status

Novo Nordisk Investigational Site

Changhua, , Taiwan

Site Status

Novo Nordisk Investigational Site

Kaoshiung, , Taiwan

Site Status

Novo Nordisk Investigational Site

Bangkok, , Thailand

Site Status

Novo Nordisk Investigational Site

Bangkok, , Thailand

Site Status

Countries

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Australia Hong Kong Malaysia Philippines Singapore Taiwan Thailand

References

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Bebakar WM, Chow CC, Kadir KA, Suwanwalaikorn S, Vaz JA, Bech OM; BIAsp-3021 study group. Adding biphasic insulin aspart 30 once or twice daily is more efficacious than optimizing oral antidiabetic treatment in patients with type 2 diabetes. Diabetes Obes Metab. 2007 Sep;9(5):724-32. doi: 10.1111/j.1463-1326.2007.00743.x. Epub 2007 Jun 26.

Reference Type RESULT
PMID: 17593237 (View on PubMed)

Related Links

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http://novonordisk-trials.com

Clinical Trials at Novo Nordisk

Other Identifiers

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BIASP-3021

Identifier Type: -

Identifier Source: org_study_id

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