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NovoMix 50 vs Mixtard 50 in Type 2 Diabetes
NCT00476437Phase 3
Key facts
- Status
- Completed
- Start
- Apr 2007
- Primary completion
- Nov 2007
- Countries
- 1
- Sponsor
- Novo Nordisk
- Modality
- Recombinant Proteins and Enzymes
- Conditions
- type 2 diabetes mellitus (T2DM)
01
Overview
Phase 3, randomised, open-label trial of Insulin aspart + insulin aspart protamine in type 2 diabetes mellitus (T2DM) (2 arms), sponsored by Novo Nordisk. Primary endpoint: Incidence of hypoglycaemic episodes at 16 weeks. Started Apr 2007; status: completed.
02
Design
2 arms- Study design
- RandomizedOpen-label
Biphasic Insulin Aspart 50
NovoMix 50 administered twice daily.
Biphasic Human Insulin 50
Mixtard 50 administered twice daily.
03
Who it enrols
Patients with type 2 diabetes mellitus currently treated with twice-daily pre-mixed insulin for at least 8 weeks, with HbA1c < 11.0% and BMI < 30.0 kg/m2.
04
Endpoints
Primary
Incidence of hypoglycaemic episodes
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