Type 2 diabetes MedDRA version: 7.0 Level: LLT Classification code 10045242
Conditions
Interventions
Product Name: NovoMix 50 FlexPen
Product Code: Biphasic Insulin Aspart 50
Pharmaceutical Form: Suspension for injection
INN or Proposed INN: Insulin Aspart
CAS Number: 116094-23-6
Current Sponsor code
Sponsors
Novo Nordisk A/S
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1. Informed consent obtained before any trial-related activities. (Trial-related activities are any procedure that would not have been performed during normal management of the subject.) 2. Type 2 diabetes 3. Currently treated with human or analogue insulin once or twice daily for at least 3 months 4. Currently treated with metformin within the interval of 1000 - 2550 mg daily. The dose should have remained unchanged for a period of 2 months prior to randomisation and should be expected to remain unchanged throughout the trial period 5. Male or female age = 18 years of age 6. HbA1c = 7.5% and =12.0% (based on HPLC/ Central lab.) 7. Total daily insulin dose =65 years) yes F.1.3.1 Number of subjects for this age range
Exclusion criteria
Exclusion criteria: 1. Known or suspected allergy to trial products or related products 2. Previous participation in this trial (participation defined as screening) 3. BMI 40.0 kg/m2 4. Impaired hepatic function (alanine aminotransferase (ALAT/SGPT) or alkaline phosphatase (AP) = 2 times upper referenced limit) 5. Impaired renal function with serum creatinine = 135 µmol/L (1.5 mg/dl) 6. Cardiac disease, within the last 12 months, defined as: - decompensated heart failure (NYHA class III or IV) - unstable angina pectoris - myocardial infarction 7. Proliferative retinopathy or macular oedema requiring acute treatment 8. Metformin contraindications according to local practice 9. TZD’s within 6 months prior to randomisation 10. Pregnancy, breast-feeding, the intention to become pregnant or judged not to be using adequate contraceptive measures. For woman of childbearing potential adequate contraceptive measures are considered as: An intrauterine device, oral contraceptives and barrier methods. Except for Denmark and France where barrier methods are not accepted as adequate contraceptives 11. Mental incapacity, unwillingness or language barriers precluding adequate understanding or co-operation 12. Any disease or condition which the Investigator feels would interfere with the trial 13. Receipt of any investigational drug within 1 month prior to this trial.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: To investigate if BIAsp 50-50-50(30) and BIAsp 70-70-70(30) is non-inferior, and superior in the event of non-inferiority, compared with BIAsp 30-30 all in combination with metformin with respect to glycaemic control as measured by HbA1c after 36 weeks of treatment in subjects with type 2 diabetes;;Secondary Objective: Compare BIAsp 70-70-70(30) and BIAsp 50-50-50(30) with BIAsp 30-30 with regards to: 1. Glycaemic control 2. Safety profiles 3. Changes in body weight and total daily insulin dose 4. Treatment Satisfaction and Well Being 5. Prandial and average prandial blood glucose increments over each of the 3 main meals Percentages of subjects achieving...: 6. HbA1c < 6.5 % 7. HbA1c < 7.0 % 8. a HbA1c reduction of more than 1.0 % from baseline 9. the treatment target of HbA1c < 6.5 % without experiencing hypoglycaemic episodes during the last 12 weeks of treatment 10. the treatment target of HbA1c < 7.0 % without experiencing hypoglycaemic episodes during the last 12 weeks of treatment Compare BIAsp 70-70-70(30) and BIAsp 50-50-50(30) with regards to: 11. Percentages of subjects switching the dinner injection to BIAsp 30 Compare BIAsp 70-70-70(30), BIAsp 50-50-50(30) and BIAsp 30-30 with regards to: 12. Percentages of subjects reaching a pre-breakfast PG = 7.0 mmol/L;Primary end point(s): • HbA1c assessed by central laboratory | — |
Countries
Austria, Czech Republic, Denmark, Hungary, Italy, Spain, United Kingdom
Outcome results
None listed