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

Phase 4

Completed

• Conditions: Diabetes; Diabetes Mellitus, Type 2

• Registration Number: NCT00264901
• Lead Sponsor: Novo Nordisk A/S

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 guided titration according to the local standard of care.

Detailed Description

Not available

Study Timeline

• Study Start: 2005-10
• Study First Submitted: 2005-12-12
• Study First Submitted QC: 2005-12-12
• Study First Posted: 2005-12-13
• Primary Completion: 2006-11
• Study Completion: 2006-11
• Status Verified: 2017-01
• Last Update Submitted: 2017-01-30
• Last Update Posted: 2017-01-31

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 5652

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Primary Outcome Measures

Name	Time	Method
Comparison of the change from baseline to end of treatment	after 26 weeks in the value of laboratory-measured HbA1c between the self adjustment versus the standard of care group

Secondary Outcome Measures

Name	Time	Method
Spontaneously reported adverse events during the trial
Incidence of severe hypoglycaemic during the trial nocturnal (11 pm - 6 am)
FPG during the trial (central laboratory) at Visit 2 and Visit 3
Proportion of subjects achieving HbA1C <= 7.0% at Visit 2 and Visit 3
Insulin detemir doses at Visit 2 and Visit 3
Within-subject variation of before-breakfast SMPG values at Visit 2 and Visit 3

Trial Locations

Locations (1)

Novo Nordisk Investigational Site; 🇺🇸 Plainsboro, New Jersey, United States