NCT01467323
Completed
Phase 3
An Open-labelled, Randomised, Parallel Group, Multicentre, Multinational Efficacy and Safety Comparison of Biphasic Insulin Aspart 30 and Biphasic Human Insulin 30/70 as Meal Related Insulin in a Twice Daily Regimen in Type 1 and Type 2 Diabetic Subjects
Overview
- Phase
- Phase 3
- Status
- Completed
- Sponsor
- Novo Nordisk A/S
- Enrollment
- 303
- Locations
- 1
- Primary Endpoint
- HbA1c (glycosylated haemoglobin A1c)
Overview
Brief Summary
This trial is conducted in Europe. The aim of this trial is to evaluate the efficacy and safety of biphasic insulin aspart 30 in subjects with type 1 or type 2 diabetes.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Treatment
- Masking
- None
Eligibility Criteria
- Ages
- 18 Years to — (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
Inclusion Criteria
- •Subjects with insulin requiring type 1 or type 2 diabetes for at least 24 months
- •Current treatment with human insulin (either premix of short and long/intermediate acting insulin) in a twice daily treatment regimen preparation and/or self-mix for at least 12 months
- •Body mass index (BMI) below or equal to 35.0 kg/m\^2
- •HbA1c below or equal to 11.0%
Exclusion Criteria
- •Total daily insulin dose at least 1.4 IU/kg
- •Treatment with oral hypoglycaemic agents within the month prior to inclusion
- •Recurrent severe hypoglycaemia (as judged by the investigator)
- •Active proliferative retinopathy
- •Impaired renal function with creatinine at least 150 mcmol/l (1.7 mg/dl)
- •History of pancreatitis
Arms & Interventions
A
Experimental
Intervention: biphasic insulin aspart (Drug)
B
Active Comparator
Intervention: biphasic human insulin (Drug)
Outcomes
Primary Outcomes
HbA1c (glycosylated haemoglobin A1c)
Secondary Outcomes
- 8-point blood glucose profiles
- Incidence of hypoglycaemic episodes
- Occurrence of adverse events
Investigators
Study Sites (1)
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