Comparison of Self Adjustment Versus Standard of Care Treatment in Subjects With Type 2 Diabetes
| Status: | Completed |
|---|---|
| Conditions: | Diabetes, Diabetes |
| Therapuetic Areas: | Endocrinology |
| Healthy: | No |
| Age Range: | 18 - Any |
| Updated: | 2/1/2017 |
| Start Date: | October 2005 |
| End Date: | November 2006 |
Impact of a Self-Adjusted Titration Guideline in Subjects With Type 2 Diabetes Mellitus: A Treat-to-Target of the Efficacy and Safety of Levemir® (Insulin Detemir [rDNA Origin] Injection) (PREDICTIVE™ 303)
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.
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.
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
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