Comparison of Self Adjustment Versus Standard of Care Treatment in Subjects With Type 2 Diabetes

Completed · Phase 4

Conditions studied: Diabetes, Diabetes Mellitus, Type 2

In brief

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.

Key facts

Study ID

NCT00264901

Run by

Novo Nordisk A/S

People needed

5652

Starts

2005-10-01

Expected to finish

2006-11-01

Last updated by the study team

2017-01-31

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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

You may not qualify if…

• 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

Where it is running

• Novo Nordisk Investigational Site — Plainsboro, New Jersey, United States

Full record on ClinicalTrials.gov

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