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NovoLog Mix 70/30 Titrate-To-Target in T2DM
NCT00791895Phase 4
Key facts
- Status
- Completed
- Start
- Jun 2003
- Primary completion
- Oct 2004
- Countries
- 1
- Sponsor
- Novo Nordisk
- Modality
- Recombinant Proteins and Enzymes
- Conditions
- type 2 diabetes mellitus (T2DM)
01
Overview
Phase 4, open-label, single-arm trial of Insulin aspart + insulin aspart protamine in type 2 diabetes mellitus (T2DM), sponsored by Novo Nordisk. Primary endpoint: Percentage of subjects achieving HbA1c below 6.5% at 48 weeks. Started Jun 2003; status: completed.
02
Design
1 arm- Study design
- Non-randomizedOpen-label
NovoLog Mix 70/30
Patients treated with NovoLog Mix 70/30 + OADs
03
Who it enrols
Patients with Type 2 diabetes mellitus for at least 12 months, HbA1c 7.5-10.0%, on stable OADs for at least 3 months.
04
Endpoints
Primary
Percentage of subjects achieving HbA1c below 6.5%
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