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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE4

Total Enrollment

5652 participants

Study Classification

INTERVENTIONAL

Study Start Date

2005-10-31

Study Completion Date

2006-11-30

Brief Summary

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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.

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Detailed Description

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Conditions

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Diabetes Diabetes Mellitus, Type 2

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Interventions

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insulin detemir

Intervention Type DRUG

Eligibility Criteria

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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

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No