Diabetes, Diabetes Mellitus, Type 2
Conditions
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.
Interventions
DRUGinsulin detemir
Sponsors
Novo Nordisk A/S
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 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
| Measure | Time frame |
|---|---|
| Incidence of severe hypoglycaemic during the trial nocturnal (11 pm - 6 am) | — |
| FPG during the trial (central laboratory) at Visit 2 and Visit 3 | — |
| Spontaneously reported adverse events during the trial | — |
| Insulin detemir doses at Visit 2 and Visit 3 | — |
| Within-subject variation of before-breakfast SMPG values at Visit 2 and Visit 3 | — |
| Proportion of subjects achieving HbA1C <= 7.0% at Visit 2 and Visit 3 | — |
Countries
United States
Outcome results
None listed