Status:
COMPLETED
Efficacy and Safety of Biphasic Insulin Aspart 30 in Type 1 or Type 2 Diabetes
Lead Sponsor:
Novo Nordisk A/S
Conditions:
Diabetes
Diabetes Mellitus, Type 1
Eligibility:
All Genders
18+ years
Phase:
PHASE3
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.
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
April 1 1998
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
September 1 1998
Estimated Enrollment :
303 Patients enrolled
Trial Details
Trial ID
NCT01467323
Start Date
April 1 1998
End Date
September 1 1998
Last Update
January 4 2017
Active Locations (37)
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1
Novo Nordisk Investigational Site
Graz, Austria, 8036
2
Novo Nordisk Investigational Site
Vienna, Austria, A 1080
3
Novo Nordisk Investigational Site
Anklam, Germany, 17389
4
Novo Nordisk Investigational Site
Berlin, Germany, 10559