Comparison of Self Adjustment Versus Standard of Care Treatment in Subjects With Type 2 Diabetes (PREDICTIVE™)

Novo Nordisk

Status and phase

Completed

Phase 4

Conditions

Diabetes

Diabetes Mellitus, Type 2

Treatments

Drug: insulin detemir

Study type

Interventional

Funder types

Industry

Identifiers

NCT00264901

NN304-1720

Details and patient eligibility

About

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.

Enrollment

5,652 patients

Sex

All

Ages

18+ years old

Volunteers

No Healthy Volunteers

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