Status:
COMPLETED
Comparison of Self Adjustment Versus Standard of Care Treatment in Subjects With Type 2 Diabetes
Lead Sponsor:
Novo Nordisk A/S
Conditions:
Diabetes
Diabetes Mellitus, Type 2
Eligibility:
All Genders
18+ years
Phase:
PHASE4
Brief Summary
This trial is conducted in the United States of America (USA). This trial aims for a comparison of the safety and efficacy in subjects with type 2 diabetes using either self titration or physician gui...
Eligibility Criteria
Inclusion
- Diagnosis of type 2 diabetes HbA1C \<= 12.0% within the past 12 months;
- BMI \<= 45.0 kg/m2
- Initiation, addition of, change to, or continuation of basal insulin therapy with insulin detemir as deemed necessary by Investigator
Exclusion
- Anticipated change in concomitant medication known to interfere with glucose metabolism such as systemic steroids, non-selective beta-blockers or mono amine oxidase (MAO) inhibitors.
- Proliferative retinopathy or maculopathy that has required acute treatment within the last 6 months.
- Any glucose lowering medication that is not indicated in combination with insulin, such as GLP-1 Analogues
- Known hypoglycemia unawareness or recurrent major hypoglycemia, as judged by the Investigator
Key Trial Info
Start Date :
October 1 2005
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
November 1 2006
Estimated Enrollment :
5652 Patients enrolled
Trial Details
Trial ID
NCT00264901
Start Date
October 1 2005
End Date
November 1 2006
Last Update
January 31 2017
Active Locations (1)
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1
Novo Nordisk Investigational Site
Plainsboro, New Jersey, United States, 08536