Efficacy and Safety of NovoMix® 30 in Subjects With Type 2 Diabetes
Phase 4
Completed
- Conditions
- Diabetes Mellitus, Type 2Diabetes
- Interventions
- Drug: biphasic human insulin
- Registration Number
- NCT01467401
- Lead Sponsor
- Novo Nordisk A/S
- Brief Summary
This trial is conducted in Europe. The aim of this trial is to investigate the efficacy and safety of biphasic insulin aspart (NovoMix®30) to that of biphasic human insulin (Mixtard® 30) in subjects with type 2 diabetes.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 292
Inclusion Criteria
- Type 2 diabetes for at least 24 months
- Insulin treatment for the pase 3 months
- HbA1c (glycosylated haemoglobin) below 13%
- BMI (Body Mass Index) below 40 kg/m^2
- Ability and willingness to perform self-blood glucose monitoring
Exclusion Criteria
- Receipt of any investigational drug within 4 weeks prior to this trial
- Treatment of OHAs (Oral Hypoglycaemic Agents) within 4 weeks prior to this trial
- Total daily insulin dosage less than or equal to 1.8 IU/kg
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 (glycolated haemoglobin)
- Secondary Outcome Measures
Name Time Method Prandial increment in blood glucose 7-point blood glucose profile Number and severity of local tolerability issues at the injection site Number and severity of hypoglycaemic episodes Number and severity of adverse events
Trial Locations
- Locations (1)
Novo Nordisk Investigational Site
🇸🇪Östersund, Sweden
Novo Nordisk Investigational Site🇸🇪Östersund, Sweden