NCT00569998CompletedPhase 3
An Open-label, Multi-centre, Multi-national, Comparative, Randomised, Cross-over Trial Evaluating Preference as Well as Performance, Acceptance, Handling and Safety of NovoPen™ 4 (MS236) Versus NovoPen 3® in Insulin Treated Diabetic Patients
Conditions
Trial Snapshot
- Phase
- Phase 3
- Status
- Completed
- Sponsor
- Novo Nordisk A/S
- Enrollment
- 208
- Locations
- 24
- Primary Endpoint
- Evaluation of overall pen preference
Study Overview
Brief Summary
This trial is conducted in Europe. The aim of this trial is to compare two insulin delivery pens in the everyday life setting of patients with diabetes treated with insulin.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Crossover
- Primary Purpose
- Treatment
- Masking
- None
Eligibility Criteria
- Ages
- 9 Years to — (Child, Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
Inclusion Criteria
- •Type 1 or type 2 diabetes mellitus for at least 12 months
- •Adults at least 18 years
- •Children/adolescents between 9-18 years
- •HbA1c lesser than or equal to 11.0%
Exclusion Criteria
- •Known or suspected alcohol or drug abuse
- •Patients who are not able to read the user manual (may wear glasses if needed)
- •Hypoglycaemic unawareness as judged by the investigator
- •Visual and/or dexterity impairments as judged by the investigator
Outcomes
Primary Outcomes
Evaluation of overall pen preference
Time Frame: after 12 weeks of treatment
Secondary Outcomes
- Adverse device effects
- Adverse events
- HbA1c
Investigators
Study Sites (24)
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