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

• Status: Completed
• Trial end date: 2006-11-01
• Target enrollment: 0
• Participant gender: All

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 guided titration according to the local standard of care.

• Phase: Phase 4
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Novo Nordisk A/S
• Treatments: Insulin; Insulin Detemir

Criteria

Inclusion Criteria:

• 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 Criteria:

• 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