Effectiveness and Safety of Biphasic Insulin Aspart 70/30 in Subjects With Type 2 Diabetes
Change in HbA1c With Biphasic Insulin Aspart 70/30 in Two Different Treatment Regiments in Subjects With Type 2 Diabetes Inadequately Controlled With Oral Anti-diabetic Drug Therapy.
1 other identifier
interventional
321
1 country
8
Brief Summary
This trial is conducted in Asia. This is a clinical trial investigating the effectiveness of using Biphasic Insulin Aspart 70/30 in two different treatment regiments for 6 months in subjects with type 2 diabetes, not well controlled on their current oral anti-diabetic drug therapy.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for phase_4 diabetes
Started Jul 2005
Shorter than P25 for phase_4 diabetes
8 active sites
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
July 1, 2005
CompletedFirst Submitted
Initial submission to the registry
August 29, 2005
CompletedFirst Posted
Study publicly available on registry
September 16, 2005
CompletedPrimary Completion
Last participant's last visit for primary outcome
July 1, 2006
CompletedStudy Completion
Last participant's last visit for all outcomes
July 1, 2006
CompletedJanuary 6, 2017
January 1, 2017
1 year
August 29, 2005
January 5, 2017
Conditions
Outcome Measures
Primary Outcomes (1)
Change in HbA1c
After 24 weeks of treatment
Secondary Outcomes (6)
Adverse events
Weight change
Fasting blood glucose
Hypoglycaemic episodes
2-hour postprandial blood glucose
- +1 more secondary outcomes
Interventions
Eligibility Criteria
You may qualify if:
- Type 2 diabetes
- HbA1C = 7.5%
- Insulin naïve
- Current treatment by Oral Anti-diabetic Drugs
You may not qualify if:
- Severe medical conditions
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Novo Nordisk A/Slead
Study Sites (8)
Novo Nordisk Investigational Site
Beijing, Beijing Municipality, 100029, China
Novo Nordisk Investigational Site
Beijing, Beijing Municipality, 100730, China
Novo Nordisk Investigational Site
Guangzhou, Guangdong, 510120, China
Novo Nordisk Investigational Site
Wuhan, Hubei, 430022, China
Novo Nordisk Investigational Site
Nanjing, Jiangsu, 210008, China
Novo Nordisk Investigational Site
Xi'an, Shaanxi, 710032, China
Novo Nordisk Investigational Site
Shanghai, Shanghai Municipality, 200003, China
Novo Nordisk Investigational Site
Tianjin, Tianjin Municipality, 300070, China
Related Publications (1)
Yang W, Ji Q, Zhu D, Yang J, Chen L, Liu Z, Yu D, Yan L. Biphasic insulin aspart 30 three times daily is more effective than a twice-daily regimen, without increasing hypoglycemia, in Chinese subjects with type 2 diabetes inadequately controlled on oral antidiabetes drugs. Diabetes Care. 2008 May;31(5):852-6. doi: 10.2337/dc07-1992. Epub 2008 Feb 11.
PMID: 18268073RESULT
Related Links
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Study Officials
- STUDY DIRECTOR
Global Clinical Registry (GCR, 1452)
Novo Nordisk A/S
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
August 29, 2005
First Posted
September 16, 2005
Study Start
July 1, 2005
Primary Completion
July 1, 2006
Study Completion
July 1, 2006
Last Updated
January 6, 2017
Record last verified: 2017-01