NCT00605111

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.

Trial Health

93
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
193

participants targeted

Target at P50-P75 for phase_4 diabetes

Timeline
Completed

Started Dec 2003

Shorter than P25 for phase_4 diabetes

Geographic Reach
7 countries

17 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

December 1, 2003

Completed
10 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 1, 2004

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

October 1, 2004

Completed
3.3 years until next milestone

First Submitted

Initial submission to the registry

January 18, 2008

Completed
12 days until next milestone

First Posted

Study publicly available on registry

January 30, 2008

Completed
Last Updated

January 11, 2017

Status Verified

January 1, 2017

Enrollment Period

10 months

First QC Date

January 18, 2008

Last Update Submit

January 10, 2017

Conditions

DiabetesDiabetes Mellitus, Type 2

Outcome Measures

Primary Outcomes (1)

  • HbA1c

    after 11 weeks of treatment

Secondary Outcomes (3)

  • 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

Interventions

biphasic insulin aspartDRUG

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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%

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (17)

Novo Nordisk Investigational Site

Blacktown, New South Wales, 2148, Australia

Location

Novo Nordisk Investigational Site

Broadmeadow, New South Wales, 2292, Australia

Location

Novo Nordisk Investigational Site

Fitzroy, 3065, Australia

Location

Novo Nordisk Investigational Site

Garran, 2605, Australia

Location

Novo Nordisk Investigational Site

Stones Corner, 4120, Australia

Location

Novo Nordisk Investigational Site

Hong Kong Island, Hong Kong

Location

Novo Nordisk Investigational Site

Shatin, New Territories, Hong Kong

Location

Novo Nordisk Investigational Site

Cheras, 56000, Malaysia

Location

Novo Nordisk Investigational Site

Georgetown, Penang, 10450, Malaysia

Location

Novo Nordisk Investigational Site

Kota Bharu, Kelantan, 16150, Malaysia

Location

Novo Nordisk Investigational Site

Cebu City, 6000, Philippines

Location

Novo Nordisk Investigational Site

Quezon City, 1100, Philippines

Location

Novo Nordisk Investigational Site

Singapore, 159964, Singapore

Location

Novo Nordisk Investigational Site

Changhua, 500, Taiwan

Location

Novo Nordisk Investigational Site

Kaoshiung, 807, Taiwan

Location

Novo Nordisk Investigational Site

Bangkok, 10300, Thailand

Location

Novo Nordisk Investigational Site

Bangkok, 10330, Thailand

Location

Related 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 Obes Metab. 2007 Sep;9(5):724-32. doi: 10.1111/j.1463-1326.2007.00743.x. Epub 2007 Jun 26.

    PMID: 17593237RESULT

Related Links

MeSH Terms

Conditions

Diabetes MellitusDiabetes Mellitus, Type 2

Interventions

insulin aspart, insulin aspart protamine drug combination 30:70

Condition Hierarchy (Ancestors)

Glucose Metabolism DisordersMetabolic DiseasesNutritional and Metabolic DiseasesEndocrine System Diseases

Study Officials

  • Global Clinical Registry (GCR, 1452)

    Novo Nordisk A/S

    STUDY DIRECTOR

Study Design

Study Type
interventional
Phase
phase 4
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

January 18, 2008

First Posted

January 30, 2008

Study Start

December 1, 2003

Primary Completion

October 1, 2004

Study Completion

October 1, 2004

Last Updated

January 11, 2017

Record last verified: 2017-01

Locations

TW(2)AU(5)TH(2)HK(2)PH(2)MY(3)SG(1)