Clinical trial NCT00605111: Efficacy and Safety of Biphasic Insulin Aspart 30 in Subjects With Type 2 Diabetes
Official title: Efficacy and Safety of Initiation of Biphasic Insulin Aspart 30 Treatment in Subjects With Type 2 Diabetes Mellitus Failing OAD Therapy
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Diabetes
Diabetes Mellitus, Type 2
Lead sponsor: Novo Nordisk A/S
Sponsor class: INDUSTRY
First posted: 2008-01-30
Enrollment: 193
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.


Eligibility criteria: 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

Primary outcomes:
measure: HbA1c
timeFrame: after 11 weeks of treatment
Secondary outcomes:
measure: The proportion of subjects achieving treatment target of HbA1c below 7%
timeFrame: at 11 and 24 weeks
measure: 8-point plasma glucose profiles
timeFrame: performed at 11 and 24 weeks
measure: FPG
timeFrame: at 11 weeks and 24 weeks
Other outcomes:
Locations:
city: Blacktown
country: Australia
facility: Novo Nordisk Investigational Site
state: New South Wales
city: Broadmeadow
country: Australia
facility: Novo Nordisk Investigational Site
state: New South Wales
city: Fitzroy
country: Australia
facility: Novo Nordisk Investigational Site
city: Garran
country: Australia
facility: Novo Nordisk Investigational Site
city: Stones Corner
country: Australia
facility: Novo Nordisk Investigational Site
city: Hong Kong Island
country: Hong Kong
facility: Novo Nordisk Investigational Site
city: Shatin, New Territories
country: Hong Kong
facility: Novo Nordisk Investigational Site
city: Cheras
country: Malaysia
facility: Novo Nordisk Investigational Site
city: Georgetown, Penang
country: Malaysia
facility: Novo Nordisk Investigational Site
city: Kota Bharu, Kelantan
country: Malaysia
facility: Novo Nordisk Investigational Site
city: Cebu City
country: Philippines
facility: Novo Nordisk Investigational Site
city: Quezon City
country: Philippines
facility: Novo Nordisk Investigational Site
city: Singapore
country: Singapore
facility: Novo Nordisk Investigational Site
city: Changhua
country: Taiwan
facility: Novo Nordisk Investigational Site
city: Kaoshiung
country: Taiwan
facility: Novo Nordisk Investigational Site
city: Bangkok
country: Thailand
facility: Novo Nordisk Investigational Site
city: Bangkok
country: Thailand
facility: Novo Nordisk Investigational Site
Study officials:
affiliation: Novo Nordisk A/S
name: Global Clinical Registry (GCR, 1452)
role: STUDY_DIRECTOR
References:
citation: 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.