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Comparison of Levemir, Lantus, and NPH Insulin during exercise in T1D
NCT00313742Phase 4
Key facts
- Status
- Completed
- Start
- Apr 2006
- Primary completion
- Nov 2006
- Countries
- 2
- Sponsor
- Novo Nordisk
- Modality
- Recombinant Proteins and Enzymes
- Drugs
- insulin detemir
- Conditions
- type 1 diabetes mellitus (T1D)
01
Overview
Phase 4, randomised, open-label trial of insulin detemir in type 1 diabetes mellitus (T1D) (3 arms), sponsored by Novo Nordisk. Primary endpoint: Difference between plasma glucose pre-exercise and minimum plasma glucose (nadir) 0-150 min post-exercise at 4 weeks. Started Apr 2006; status: completed.
02
Design
3 arms- Study design
- RandomizedOpen-label
Insulin Detemir
Basal insulin detemir as part of a basal-bolus regimen.
Insulin Glargine
Basal insulin glargine as part of a basal-bolus regimen.
Insulin NPH
Basal NPH insulin as part of a basal-bolus regimen.
03
Who it enrols
Adults with Type 1 Diabetes on basal-bolus therapy with HbA1c < 10% and BMI < 32 kg/m2, excluding those with significant complications like proliferative retinopathy or recurrent major hypoglycemia.
04
Endpoints
Primary
Difference between plasma glucose pre-exercise and minimum plasma glucose (nadir) 0-150 min post-exercise
Secondary
Plasma glucose pre-exercise & post-exercise
Hypoglycaemia episodes (major and minor episodes)
Plasma glucose profile post-exercise
Incidence of adverse events during the trial
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