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GlyCEDIA: Basal-Bolus Detemir-Aspart in Hemodialyzed Diabetic Patients
NCT01828970Phase 4
Key facts
- Status
- Completed
- Start
- Jan 2010
- Primary completion
- Sep 2012
- Countries
- 1
- Modality
- Recombinant Proteins and Enzymes
- Conditions
- diabetes mellitus (DM)
01
Overview
Phase 4, open-label, single-arm trial of insulin detemir and insulin aspart in diabetes mellitus (DM), sponsored by Centre Européen d'Étude du Diabète. Primary endpoint: Mean plasma glucose level measured 3 times just before the first hemodialysis session at 3 months. Started Jan 2010; status: completed.
02
Design
1 arm- Study design
- Non-randomizedOpen-label
Basal-bolus specific insulin regimen
Basal-bolus detemir-aspart insulin regimen
03
Who it enrols
Adult patients with type 1 or type 2 diabetes on hemodialysis for >3 months with HbA1c >= 7%, excluding those with unstable anemia, short life expectancy, or active cancer.
04
Endpoints
Primary
Mean plasma glucose level measured 3 times just before the first hemodialysis session
Secondary
Glycated Hemoglobin A1c
Body weight
Insulin requirements
Symptomatic hypoglycemia
Continuous glucose monitoring parameters
Deaths and major cardiovascular events
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