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NCT00605111 Clinical Trial

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

Diabetes Mellitus, Type 2 Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data
NCT number NCT00605111
Other study ID # BIASP-3021
Secondary ID
Status Completed
Phase Phase 4
First received January 18, 2008
Last updated January 10, 2017
Start date December 2003
Est. completion date October 2004

Study information
Verified date January 2017
Source Novo Nordisk A/S
Contact n/a
Is FDA regulated No
Health authority Australia: Department of Health and Ageing Therapeutic Goods AdministrationHong Kong: Department of HealthMalaysia: Ministry of HealthPhilippines: Bureau of Food and DrugsSingapore: Health Sciences AuthorityTaiwan: Department of HealthThailand: Ministry of Public Health
Study type Interventional

Clinical Trial 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.

Recruitment information / eligibility
Status Completed
Enrollment 193
Est. completion date October 2004
Est. primary completion date October 2004
Accepts healthy volunteers No
Gender All
Age group 18 Years and older
Eligibility 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

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

Intervention

Drug:
• biphasic insulin aspart

Locations
Country Name City State
Australia Novo Nordisk Investigational Site Blacktown New South Wales
Australia Novo Nordisk Investigational Site Broadmeadow New South Wales
Australia Novo Nordisk Investigational Site Fitzroy
Australia Novo Nordisk Investigational Site Garran
Australia Novo Nordisk Investigational Site Stones Corner
Hong Kong Novo Nordisk Investigational Site Hong Kong Island
Hong Kong Novo Nordisk Investigational Site Shatin, New Territories
Malaysia Novo Nordisk Investigational Site Cheras
Malaysia Novo Nordisk Investigational Site Georgetown, Penang
Malaysia Novo Nordisk Investigational Site Kota Bharu, Kelantan
Philippines Novo Nordisk Investigational Site Cebu City
Philippines Novo Nordisk Investigational Site Quezon City
Singapore Novo Nordisk Investigational Site Singapore
Taiwan Novo Nordisk Investigational Site Changhua
Taiwan Novo Nordisk Investigational Site Kaoshiung
Thailand Novo Nordisk Investigational Site Bangkok
Thailand Novo Nordisk Investigational Site Bangkok

Sponsors (1)
Lead Sponsor Collaborator
Novo Nordisk A/S

Countries where clinical trial is conducted

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

References & Publications (1)

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 Obe — View Citation

Outcome
Type Measure Description Time frame Safety issue
Primary HbA1c after 11 weeks of treatment No
Secondary The proportion of subjects achieving treatment target of HbA1c below 7% at 11 and 24 weeks No
Secondary 8-point plasma glucose profiles performed at 11 and 24 weeks No
Secondary FPG at 11 weeks and 24 weeks No
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