NCT00274274
Completed
Phase 4
Efficacy and Safety of Insulin Aspart in a Fixed or Flexible Supplementary Insulin Therapy Regimen, With or Without Insulin Detemir in Type 2 Diabetes
Overview
- Phase
- Phase 4
- Status
- Completed
- Sponsor
- Novo Nordisk A/S
- Enrollment
- 373
- Primary Endpoint
- HbA1c
Overview
Brief Summary
This trial is conducted in Europe. This trial aims for a comparison of the efficacy and safety of Insulin Aspart, given in a fixed or in a flexible supplementary insulin therapy, with or without Insulin Detemir plus Metformin, if needed, in subjects with type 2 diabetes.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Treatment
- Masking
- None
Eligibility Criteria
- Ages
- 18 Years to — (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
Inclusion Criteria
- •Type 2 Diabetes for more than 6 months
- •Treatment with 1 or more oral anti-diabetic drugs or insulin, or a combination of these for more than 3 months
- •Body Mass Index (BMI) less than or equal to 40 kg/m2
- •HbA1c 7.0-11.0%
Exclusion Criteria
- •Treatment with short acting insulin(s) for longer than 10 days
- •Current treatment with TZDs. A TZD medication must be stopped at least 14 days before the randomization
- •Proliferative retinopathy or maculopathy requiring acute or laser treatment within the last 6 months
Outcomes
Primary Outcomes
HbA1c
Time Frame: after 52 weeks
Secondary Outcomes
- Safety parameters
- Frequency of BG measurements
- Duration of education
- Quality of Life
- Blood glucose profiles
- Percentage of patients with HbA1c less than 7.0% after 52 weeks
Investigators
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