NCT00071448CompletedPhase 3
Basal/Bolus Therapy With Insulin Aspart (NovoLog®) Versus Regular Human Insulin (Novolin® R) or Insulin Lispro (Humalog®) in Combination With NPH: An Open-Label, Randomized, Parallel Group, Multicenter Study in Children and Adolescents With Type 1 Diabetes
Conditions
Drugs
Trial Snapshot
- Phase
- Phase 3
- Status
- Completed
- Sponsor
- Novo Nordisk A/S
- Enrollment
- 378
- Locations
- 77
- Primary Endpoint
- HbA1c (glycosylated haemoglobin A1c)
Study Overview
Brief Summary
This trial is conducted in the United States of America (USA). The aim of this trial is to to determine whether insulin aspart can be used effectively and safely in paediatric patients.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Treatment
- Masking
- None
Eligibility Criteria
- Ages
- 6 Years to 18 Years (Child, Adult)
- Sex
- All
- Accepts Healthy Volunteers
- Yes
Inclusion Criteria
- •Pediatric patients with Type 1 diabetes for at least one year
- •HbA1c less than 12%
- •Willing to administer at least 3 injections per day
- •Willing to perform self monitored blood glucose (SMBG) at least 4 times per day, includes subject and/or parent/guardian, as necessary
Exclusion Criteria
- Not provided
Outcomes
Primary Outcomes
HbA1c (glycosylated haemoglobin A1c)
Secondary Outcomes
- FPG (fasting plasma glucose)
Investigators
Study Sites (77)
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