Comparison of Self Adjustment Versus Standard of Care Treatment in Subjects With Type 2 Diabetes (PREDICTIVE™)
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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 guided titration according to the local standard of care.
Impact of a Self-Adjusted Titration Guideline in Subjects With Type 2 Diabetes Mellitus: A Treat-to-Target of the Efficacy and Safety of Levemir® (Insulin Detemir [rDNA Origin] Injection) (PREDICTIVE™ 303)
Study Start Date
Primary Completion Date
Study Completion Date
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Ages Eligible for Study:
18 Years and older (Adult, Senior)
Sexes Eligible for Study:
Accepts Healthy Volunteers:
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
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