Comparison of Two Biphasic Insulin Aspart Treatments in Subjects With Type 2 Diabetes
Phase 3
Completed
- Conditions
- Diabetes Mellitus, Type 2Diabetes
- Interventions
- Drug: biphasic insulin aspart 70Drug: biphasic insulin aspart 50
- Registration Number
- NCT01520753
- Lead Sponsor
- Novo Nordisk A/S
- Brief Summary
This trial is conducted in Europe. The aim of this trial is to compare two different active treatment regimens of biphasic insulin aspart in subjects with type 2 diabetes.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 16
Inclusion Criteria
- Type 2 diabetes
- Duration of diabetes for longer than 12 months
- Body mass index (BMI) below 35.0 kg/m^2
- HbA1c below 11.0 %
- Treatment with BHI (biphasic human insulin) 20 or 30 twice daily for at least three months and in the last month as sole anti-diabetic treatment (i.e., no additional oral hypoglycaemic medication or daily use of short-acting insulin supplement)
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Exclusion Criteria
- Current treatment with agents affecting glucose metabolism
- History of drug or alcohol dependence
- Impaired hepatic function
- Impaired renal function
- Cardiac disease
- Proliferative retinopathy
- Recurrent severe hypoglycaemia or advanced neuropathy
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Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- CROSSOVER
- Arm && Interventions
Group Intervention Description BIAsp 70 + BIAsp 50 biphasic insulin aspart 50 - BIAsp 70 biphasic insulin aspart 70 - BIAsp 70 + BIAsp 50 biphasic insulin aspart 70 -
- Primary Outcome Measures
Name Time Method Fasting serum glucose
- Secondary Outcome Measures
Name Time Method 24-hour serum glucose profiles Incidence of hypoglycaemic episodes 24-hour insulin profiles Incidence of adverse events
Trial Locations
- Locations (1)
Novo Nordisk Investigational Site
🇩🇰Århus C, Denmark