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IRCT201104266297N1 IRCT 2011-07-10 Novo Nordisk A/S BIAsp-3858 Efficacy and Safety Comparison of Two Different Biphasic Insulin Aspart 30 Treatment Initiation Regimens Followed by intensification in Subjects with Type 2 Diabetes Mellitus Not Achieving Glycaemic Targets on Oral Anti Diabetic Drugs alone in Iran 2011-03-06 anticipated 300 Complete https://irct.ir/trial/6745 interventional Randomization: Randomized, Blinding: Not blinded, Placebo: Not used, Assignment: Parallel, Purpose: Treatment. 4 Diabetes Mellitus Type II. Intervention 1: Insulin therapy is indicated for the treatment of hyperglycaemia in diabetes mellitus. The purpose of this trial is to make a comparison of two different treatment strategies with Biphasic Iinsulin Aspart 30, in terms of efficacy on HbA1c levels in subjects who are not controlled on Oral Anti Diabetic therapy. Biphasic Insulin Aspart 30 will be used subcutaneously according to dosage regimen that given by the titration guideline. In the first intervention subjects start treatment with Biphasic Insulin Aspart 30 15 minuets before breakfast (starting with 12 units). Intervention 2: Insulin therapy is indicated for the treatment of hyperglycaemia in diabetes mellitus. The purpose of this trial is to make a comparison of two different treatment strategies with Biphasic Iinsulin Aspart 30, in terms of efficacy on HbA1c levels in subjects who are not controlled on Oral Anti Diabetic therapy. Biphasic Insulin Aspart 30 will be used subcutaneously according to dosage regimen that given by the titration guideline. In the second intervention subjects start treatment with Biphasic Insulin Aspart 30 15 minuets before dinner (starting with 12 units).

public Sayeh Tadayon

11th Floor, Kian Tower, No 1387, Upper Dastjerdi St, Vali Asr St

Tehran Iran (Islamic Republic of) +98 21 8864 5225 sayt@novonordisk.com Novo Nordisk scientific Sayeh Tadayon

11th Floor, Kian Tower, No 1387, Upper Dastjerdi Dt, Vali Asr St

Tehran Iran (Islamic Republic of) 1968643111 +98 91288645225 ehpa@novonordisk.com Novo Nordisk Pars Iran (Islamic Republic of) Iran (Islamic Republic of) Iran (Islamic Republic of) Iran (Islamic Republic of) Iran (Islamic Republic of) 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. Diagnosed with type 2 diabetes for a minimum of 6 months prior to Visit 1. 3. Male or female, age ≥18 years of age 4. HbA1c ≥ 7.0 %- ≤ 11 % at screening 5. Subject is insulin naïve (short-term insulin treatment of up to 14 days is allowed) 6. An antidiabetic regimen that has been stable for at least 3 months prior to screening 7. An antidiabetic regimen that includes a minimum of 2 OADs 8. OADs dosed at ≥ 50% of the maximum recommended dose 9. Able and willing to adhere to the therapeutic regimen 10. Able and willing to perform SMBG testing as per protocol 11. Opthalmoscopic examination within 12 months prior to screening Exclusion Criteria 1. Known or suspected hypersensitivity to trial product(s) or related products 2. Females of childbearing potential who are pregnant, breast-feeding or intend to become pregnant or are not using adequate contraceptive methods (adequate contraceptive measures as required by local law or practice). 3. The receipt of any investigational medicinal product within one month prior to this trial. 4. Suffer from a life threatening disease (cancer) 5. Active proliferative retinopathy or maculopathy requiring treatment within 6 months prior to Screening 6. Cardiac disease: class III or IV CHF, unstable angina, and or any myocardial infarction (treated or untreated) within 6 months prior to screening 7. Hepatic insufficiency (Alanine aminotransferase (ALT) or Aspartate aminotransferase (AST) > 2 times the central laboratory's upper reference limit) 8. Renal insufficiency (serum creatinine > 1.6 mg/dl for males; 1.4 mg/dl for females 9. Recurrent hypoglycaemia or hypoglycaemic unawareness 10. Anemia (haemoglobin < 10 mg/dl) 11. Use of concomitant medications which may alter glucose metabolism including but not limited to: systemic or inhaled glucocorticoids, anabolic steroids, non-selective beta-blockers 12. Known or suspected abuse of alcohol, narcotics or illicit substances 13. Mental incapacity, psychiatric disorder, unwillingness or language barriers precluding adequate understanding or co-operation, including subjects not able to read or write 14. Any conditions that the Investigator judges would interfere with trial participation or evaluation of the results 18 years no limit Both E11 Non-insulin-dependent diabetes mellitus type II Treatment - Drugs Treatment - Drugs Insulin therapy is indicated for the treatment of hyperglycaemia in diabetes mellitus. The purpose of this trial is to make a comparison of two different treatment strategies with Biphasic Iinsulin Aspart 30, in terms of efficacy on HbA1c levels in subjects who are not controlled on Oral Anti Diabetic therapy. Biphasic Insulin Aspart 30 will be used subcutaneously according to dosage regimen that given by the titration guideline. In the first intervention subjects start treatment with Biphasic Insulin Aspart 30 15 minuets before breakfast (starting with 12 units). Insulin therapy is indicated for the treatment of hyperglycaemia in diabetes mellitus. The purpose of this trial is to make a comparison of two different treatment strategies with Biphasic Iinsulin Aspart 30, in terms of efficacy on HbA1c levels in subjects who are not controlled on Oral Anti Diabetic therapy. Biphasic Insulin Aspart 30 will be used subcutaneously according to dosage regimen that given by the titration guideline. In the second intervention subjects start treatment with Biphasic Insulin Aspart 30 15 minuets before dinner (starting with 12 units). HbA1c levels. Timepoint: visit 8 (end of phase I). Method of measurement: Laboratory Assessment. Percentage of subjects achieving HbA1c < 7%. Timepoint: visit 8, 15 and 23. Method of measurement: Laboratory Assessment. FPG levels. Timepoint: end of phaseI, II and III, measured at visits 8, 15, 23. Method of measurement: Laboratory Assessment. 8-point plasma glucose profiles. Timepoint: levels at visits 9, 16, 23. Method of measurement: Subcutaneous Measurement of Blood Glucose. HbA1c level. Timepoint: visits 15 and 23. Method of measurement: Laboratory Assessment. NCT01215435 clinicaltrial.gov Novo Nordisk A/S Approved 2010-08-10 Ethical Committee of Endocrine Research Centre for Shaheed Beheshti University of MEdical Sciences Research Institute For Endocrine Sciences, #24 Parvaneh st, Yemen st, Chamran Exp Tehran Iran (Islamic Republic of) Approved 2010-08-08 Ethics Committee of Tehran University of Medical Sciences Nect to Milad Tower, West Hemmat Exp. Way Tehran Iran (Islamic Republic of) Approved 2010-11-07 National Ethics Committee for Research in Medical Sciences 3rd Floor, Deputy of Research, Azadi Avenue, Tehran Tehran Iran (Islamic Republic of)