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Biphasic Insulin Aspart 30 + Metformin in Chinese T2D Patients
NCT00669864Phase 4
Key facts
- Status
- Completed
- Start
- Nov 2007
- Primary completion
- Apr 2009
- 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 biphasic insulin aspart in type 2 diabetes mellitus (T2DM), sponsored by Novo Nordisk. Primary endpoint: Change in HbA1c (Glycosylated Haemoglobin A1c) at 16 weeks. Started Nov 2007; status: completed.
02
Design
1 arm- Study design
- Non-randomizedOpen-labelSingle group
BIAsp 30-30
Biphasic insulin aspart 30 + Metformin
03
Who it enrols
Chinese subjects with type 2 diabetes inadequately controlled with once or twice daily basal insulin.
04
Endpoints
Primary
Change in HbA1c (Glycosylated Haemoglobin A1c)
Secondary
Change in 8-point Plasma Glucose Profile
Percentage of Subjects Achieving HbA1c Less Than 7.0%
Percentage of Subjects Achieving HbA1c Below or Equal to 6.5%
Hypoglycaemic Episodes
Hypoglycaemic Episodes, Diurnal/Nocturnal
05
Results
Primary endpoints met
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