Efficacy and Safety of Biphasic Insulin Aspart 30 in Type 1 or Type 2 Diabetes
Phase 3
Completed
- Conditions
- DiabetesDiabetes Mellitus, Type 1Diabetes Mellitus, Type 2
- Interventions
- Drug: biphasic insulin aspartDrug: biphasic human insulin
- Registration Number
- NCT01467323
- Lead Sponsor
- Novo Nordisk A/S
- 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.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 303
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%
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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
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Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description A biphasic insulin aspart - B biphasic human insulin -
- Primary Outcome Measures
Name Time Method HbA1c (glycosylated haemoglobin A1c)
- Secondary Outcome Measures
Name Time Method 8-point blood glucose profiles Incidence of hypoglycaemic episodes Occurrence of adverse events
Trial Locations
- Locations (1)
Novo Nordisk Investigational Site
🇬🇧Whiston, United Kingdom