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Insulin Aspart vs Human Insulin or Lispro in Pediatric Type 1 Diabetes
NCT00071448Phase 3
Key facts
- Status
- Completed
- Start
- Jun 2002
- Primary completion
- Jun 2004
- Countries
- 1
- Sponsor
- Novo Nordisk
- Modality
- Recombinant Proteins and Enzymes
- Drugs
- insulin aspart
- Conditions
- type 1 diabetes mellitus (T1D)
01
Overview
Phase 3, randomised, open-label trial of insulin aspart in type 1 diabetes mellitus (T1D) (3 arms), sponsored by Novo Nordisk. Primary endpoint: Glycosylated Haemoglobin A1c. Started Jun 2002; status: completed.
02
Design
3 arms- Study design
- RandomizedOpen-label
Insulin Aspart + NPH
Insulin aspart (bolus) + NPH (basal)
Regular Human Insulin + NPH
Regular Human Insulin (bolus) + NPH (basal)
Insulin Lispro + NPH
Insulin lispro (bolus) + NPH (basal)
03
Endpoints
Primary
Glycosylated Haemoglobin A1c
Secondary
Fasting Plasma Glucose
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