Biphasic Insulin Aspart 30 in Type 2 Diabetes Failing OAD Therapy
NCT ID: NCT00598793
Last Updated: 2017-01-09
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.
COMPLETED
PHASE3
242 participants
INTERVENTIONAL
2002-11-30
2004-03-31
Brief Summary
Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.
Related Clinical Trials
Explore similar clinical trials based on study characteristics and research focus.
Efficacy of Biphasic Insulin Aspart 30 in Type 2 Diabetics Failing on OADs
NCT00791895
Comparison of Biphasic Insulin Aspart 30 Versus Insulin Glargine Both in Combination With Metformin and Glimepiride in Subjects With Type 2 Diabetes
NCT00469092
Efficacy of Biphasic Insulin Aspart 30 in Subjects With Type 2 Diabetes Failing on OADs
NCT01486862
Efficacy and Safety of Biphasic Insulin Aspart 30 FlexPen™ in Subjects With Type 2 Diabetes
NCT01704378
Frequency of Episodes of Hypoglycaemia During Treatment With Biphasic Insulin Aspart 30 in Type 2 Diabetes
NCT01487798
Detailed Description
Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.
Conditions
See the medical conditions and disease areas that this research is targeting or investigating.
Study Design
Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.
RANDOMIZED
PARALLEL
TREATMENT
NONE
Interventions
Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.
biphasic insulin aspart
insulin glargine
metformin
pioglitazone
Eligibility Criteria
Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.
Inclusion Criteria
* Currently treated with OADs alone or combined with other treatment for at least 3 months
* BMI below 40 kg/m2 and body weight below 125 kg
* HbA1c greater than or equal to 8%
Exclusion Criteria
* Pregnant, breastfeeding or intention of becoming pregnant
* Allergy to any of the trial products
* Inability or unwillingness to perform SMBG
18 Years
75 Years
ALL
No
Sponsors
Meet the organizations funding or collaborating on the study and learn about their roles.
Novo Nordisk A/S
INDUSTRY
Responsible Party
Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.
Principal Investigators
Learn about the lead researchers overseeing the trial and their institutional affiliations.
Global Clinical Registry (GCR, 1452)
Role: STUDY_DIRECTOR
Novo Nordisk A/S
Locations
Explore where the study is taking place and check the recruitment status at each participating site.
Novo Nordisk Investigational Site
Concord, California, United States
Novo Nordisk Investigational Site
Los Angeles, California, United States
Novo Nordisk Investigational Site
Walnut Creek, California, United States
Novo Nordisk Investigational Site
Melbourne, Florida, United States
Novo Nordisk Investigational Site
Melbourne, Florida, United States
Novo Nordisk Investigational Site
West Palm Beach, Florida, United States
Novo Nordisk Investigational Site
Atlanta, Georgia, United States
Novo Nordisk Investigational Site
Marietta, Georgia, United States
Novo Nordisk Investigational Site
Idaho Falls, Idaho, United States
Novo Nordisk Investigational Site
Chicago, Illinois, United States
Novo Nordisk Investigational Site
Lexington, Kentucky, United States
Novo Nordisk Investigational Site
Buffalo, New York, United States
Novo Nordisk Investigational Site
Asheville, North Carolina, United States
Novo Nordisk Investigational Site
Canton, Ohio, United States
Novo Nordisk Investigational Site
Columbus, Ohio, United States
Novo Nordisk Investigational Site
Medford, Oregon, United States
Novo Nordisk Investigational Site
Hershey, Pennsylvania, United States
Novo Nordisk Investigational Site
Greer, South Carolina, United States
Novo Nordisk Investigational Site
Dallas, Texas, United States
Novo Nordisk Investigational Site
Dallas, Texas, United States
Novo Nordisk Investigational Site
Dallas, Texas, United States
Novo Nordisk Investigational Site
Dallas, Texas, United States
Novo Nordisk Investigational Site
Houston, Texas, United States
Novo Nordisk Investigational Site
Midland, Texas, United States
Novo Nordisk Investigational Site
San Antonio, Texas, United States
Novo Nordisk Investigational Site
Warrenton, Virginia, United States
Novo Nordisk Investigational Site
Renton, Washington, United States
Countries
Review the countries where the study has at least one active or historical site.
References
Explore related publications, articles, or registry entries linked to this study.
Raskin P, Allen E, Hollander P, Lewin A, Gabbay RA, Hu P, Bode B, Garber A; INITIATE Study Group. Initiating insulin therapy in type 2 Diabetes: a comparison of biphasic and basal insulin analogs. Diabetes Care. 2005 Feb;28(2):260-5. doi: 10.2337/diacare.28.2.260.
Garber AJ, Ligthelm R, Christiansen JS, Liebl A. Premixed insulin treatment for type 2 diabetes: analogue or human? Diabetes Obes Metab. 2007 Sep;9(5):630-9. doi: 10.1111/j.1463-1326.2006.00654.x.
Raskin P. Initiation of insulin therapy in patients with type 2 diabetes failing oral therapy: response to Mikhail and Cope and to Janka. Diabetes Care. 2005 Nov;28(11):2811. doi: 10.2337/diacare.28.11.2811. No abstract available.
Brod M, Cobden D, Lammert M, Bushnell D, Raskin P. Examining correlates of treatment satisfaction for injectable insulin in type 2 diabetes: lessons learned from a clinical trial comparing biphasic and basal analogues. Health Qual Life Outcomes. 2007 Feb 7;5:8. doi: 10.1186/1477-7525-5-8.
Ray JA, Valentine WJ, Roze S, Nicklasson L, Cobden D, Raskin P, Garber A, Palmer AJ. Insulin therapy in type 2 diabetes patients failing oral agents: cost-effectiveness of biphasic insulin aspart 70/30 vs. insulin glargine in the US. Diabetes Obes Metab. 2007 Jan;9(1):103-13. doi: 10.1111/j.1463-1326.2006.00581.x.
Raskin PR, Hollander PA, Lewin A, Gabbay RA, Bode B, Garber AJ; INITIATE Study Group. Basal insulin or premix analogue therapy in type 2 diabetes patients. Eur J Intern Med. 2007 Jan;18(1):56-62. doi: 10.1016/j.ejim.2006.09.006.
Valentine WJ, Palmer AJ, Lammert M, Nicklasson L, Foos V, Roze S. Long-term clinical and cost outcomes of treatment with biphasic insulin aspart 30/70 versus insulin glargine in insulin naive type 2 diabetes patients: cost-effectiveness analysis in the UK setting. Curr Med Res Opin. 2005 Dec;21(12):2063-71. doi: 10.1185/030079905X74989.
Goodall G, Jendle JH, Valentine WJ, Munro V, Brandt AB, Ray JA, Roze S, Foos V, Palmer AJ. Biphasic insulin aspart 70/30 vs. insulin glargine in insulin naive type 2 diabetes patients: modelling the long-term health economic implications in a Swedish setting. Int J Clin Pract. 2008 Jun;62(6):869-76. doi: 10.1111/j.1742-1241.2008.01766.x.
Related Links
Access external resources that provide additional context or updates about the study.
Clinical Trials at Novo Nordisk
Other Identifiers
Review additional registry numbers or institutional identifiers associated with this trial.
BIASP-2163
Identifier Type: -
Identifier Source: org_study_id
More Related Trials
Additional clinical trials that may be relevant based on similarity analysis.