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1 Clinical Trial Details (PDF Generation Date :- Sun, 10 Mar :06:46 GMT) CTRI Number Last Modified On 29/11/2018 Post Graduate Thesis Type of Trial Type of Study Study Design Public Title of Study Scientific Title of Study CTRI/2017/01/ [Registered on: 06/01/2017] - Trial Registered Prospectively No Interventional Drug Randomized, Parallel Group, Active Controlled Trial To Compare the Effect and Safety of Insulin Degludec/Insulin Aspart vs. Insulin Glargine Plus Insulin Aspart in Subjects With Type 2 Diabetes Treated With Basal Insulin With or Without Oral Antidiabetic Treatment in Need of Treatment Intensification. "A 38 week trial comparing effect and safety of insulin degludec/insulin aspart vs. insulin glargine plus insulin aspart in subjects with type 2 diabetes treated with basal insulin with or without oral antidiabetic treatment in need of treatment intensification." Secondary IDs if Any Secondary ID Identifier Details of Principal Investigator or overall Trial Coordinator (multi-center study) EudraCT NN version 3.0 dated 04 May 2016 U Designation Affiliation Protocol Number UTN Details of Principal Investigator Details Contact Person (Scientific Query) Details Contact Person (Public Query) Phone Fax Designation Affiliation Details Contact Person (Scientific Query) Dr Anil N Shinde Director Clinical, Medical, Regulatory Affairs & Quality (CMRQ) Novo Nordisk Private Ltd. Phone Fax Designation Affiliation Novo Nordisk Private Ltd. Plot No.32, EPIP Area, Whitefield Bangalore Karnataka Bangalore KARNATAKA ansd@novonordisk.com Details Contact Person (Public Query) Dr Anil N Shinde Director Clinical, Medical, Regulatory Affairs & Quality (CMRQ) Novo Nordisk Private Ltd. Novo Nordisk Private Ltd. Plot No.32, EPIP Area, Whitefield Bangalore Karnataka Bangalore KARNATAKA page 1 / 7

2 Source of Monetary or Material Support Primary Sponsor Details of Secondary Sponsor Countries of Recruitment Sites of Study Phone Fax Source of Monetary or Material Support > Novo Nordisk A/S c/o Plot No.32, 47-50,EPIP Area, Whitefield, Bangalore Type of Sponsor NIL List of Countries Algeria Czech Republic Russian Federation Serbia Turkey United States of America of Principal Investigator Dr Yashdeep Gupta Dr Sanjay Chatterjee Primary Sponsor Details Novo Nordisk AS Novo Nordisk A/S - c/o Plot No.32, 47-50,EPIP Area, Whitefield, Bangalore Pharmaceutical industry-global NIL of Site Site Phone/Fax/ All Institute of Medical Sciences Apollo Gleneagles Hospitals Department of Endocrinology and Metabolism 3rd Floor, yash_deep_gupta@yah Biotechnology Block, All oo.co.in Institute of Medical Sciences New Delhi New Delhi DELHI 58 canal circular Road, Kolkata West Bengal Kolkata WEST BENGAL Dr Sambit Das Apollo Hospitals, Plot No. 251, Sainik School Road, Unit 15, Bhubaneshwar , Odisha Cuttack ORISSA Dr Amit Patel Dr Chandni BSES Municipal General hospital S.V. Road, opposite railway station, Andheri (west), Mumbai Maharashtra, " Mumbai MAHARASHTRA Calicut Medical College Government Medical College Campus, Medical College Rd, sanjay_doc@yahoo.co.i n sambitd2001@yahoo.c o.in docamit79@gmail.com chandnidr@gmail.com page 2 / 7

3 Details of Ethics Committee Kozhikode, Kerala Kozhikode KERALA Dr K D Modi CARE Hospitals , Jawaharlal Nehru Road, Near Exhibition Ground, Nampally Hyderabad , Telangana Hyderabad ANDHRA PRADESH Dr I Ranjit Unnikrishnan Dr Mohans Diabetes Specialities Center and Madras Diabetes Research Foundation No. 6B, Conran Smith Road, Gopalapuram, Chennai , Tamil Nadu Chennai TAMIL NADU Dr Sruti Chandrasekar Global Health City 439 Cheran Nagar, Perumbakkam, Chennai Chennai TAMIL NADU Dr Girithara Gopalakrishnan Jayram Naidu Dr Anupam Prakash Dr Piyush Desai Dr P V Rao Dr Ajay Rotte KG Hospital and Post Graduate Medical Institute Lady Hardinge Medical College and S.S.K. Hospital Nirmal Hospital Private Limited No 5 Govt. Arts College Road, Coimbatore , Tamil Nadu,. Coimbatore TAMIL NADU Room No. 1014, Department of Medicine, First Floor, Old Building, New Delhi New Delhi DELHI Ring Road, Surat , Gujarat Surat GUJARAT Ramdev Rao Hospital Opp. Vivekananda Kumudini Devi Diabetes Nagar Colony, Centre Kukatapally HYDERABAD TELANGANA Hyderabad ANDHRA PRADESH United CIIGMA Institute of medical Sciences Pvt.Ltd. Plot No. 6, 7, Survey No 10, Shahnoorwadi Dargah Road, Aurangabad , Maharashtra Aurangabad MAHARASHTRA drkdmodi@yahoo.co.in drranjit@drmohans.com sruti.chandrasekaran@ gmail.com drgirimd@yahoo.com prakashanupam@hotm ail.com drpiyushdesai@gmail.c om raopaturi@gmail.com avrotte07@gmail.com of Committee Approval Status Date of Approval Is Independent Ethics Committee? Ethics Committee Apollo Hospital Approved 08/10/2016 No page 3 / 7

4 Regulatory Clearance Status from DCGI Health Condition / Problems Studied Intervention / Comparator Agent Instituitional Ethics Committee, Apollo Gleneagles Hospitals "Ethics Committee, Government Medical College, Kozhikode "Institutional Ethics Committee, Global Hospital & Health City Ethics Committee BSES Municipal General Hospital Ethics Committee For Human Research, Lady Hardinge Medical College & Associated Hospitals Ethics Committee Kodlikeri Memorial Hospital and group of CIIGMA Hospital, United CIIGMA Institute of Medical Sciences Pvt.Ltd, Institutional Ethics Committe, Ramdevrao Hospital Kukatpally Institutional Ethics Committee Care Foundation, Care Hospitals, CARE Convergence Centre Institutional Ethics Committee of Madras Approved 24/09/2016 No Approved 23/12/2016 No Approved 16/11/2016 No Approved 13/12/2016 No Approved 09/05/2017 No Approved 28/09/2016 No Approved 24/12/2016 No Approved 20/09/2016 No Approved 16/01/2017 No Institutional Ethics Approved 10/01/2017 No Committee, AIIMS, New Delhi Nirmal Hospital Private Limited Ethics Committee Approved 20/10/2016 No Regional Ethics Committee, Department of Diabetology, KG Hospital." Approved 19/11/2016 No Status Date Approved/Obtained 03/01/2017 Health Type Patients Patients Condition Type 2 Diabetes Mellitus Type 2 diabetes mellitus Type Details Intervention Insulin Degludec / Insulin Aspart (Ryzodeg) 100 units/ml Solution for Subcutaneous injection, once daily for 26 weeks and will be adminstered twice daily post 26 weeks of treatment if page 4 / 7

5 Inclusion Criteria intensification is required until 38 weeks Comparator Agent Insulin Aspart (NovoRapid) 100 units/ml Solution for Subcutaneous injection, once daily for 26 weeks and will be admistered twice daily post 26 weeks if instentisification is needed and thrice daily post 32 weeks if further intensification is needed Intervention Human isophane insulin (NPH) (Insulatard) Intervention Biphasic insulin aspart 30 (BiAsp 30) (NovoMix 30) 100 IU/mL Suspension for Subcutaneous injection, twice daily for 7 to 12 days during washout period post 38 weeks of treatment 100 units/ml Suspension for Subcutaneous injection, twice daily for 7 to 12 days during washout period post 38 weeks of treatment Comparator Agent Insulin Glargine (Lantus) 100 units/ml Solution for Subcutaneous injection, once daily for 38 weeks Age From Age To Gender Details Year(s) Year(s) Both Inclusion Criteria "1. Informed consent obtained before any trial-related activities. Trial-related activities are any procedures that are carried out as part of the trial, including activities to determine suitability for the trial 2. Male or female, age? 18 years at the time of signing informed consent 3. Diagnosed with type 2 diabetes mellitus 4. Treated with any basal insulin? 90 days prior to the day of screening 5. Subject not on any OAD(s) prior to trial participation OR subjects on stable daily dose(s) of OAD(s) for at least 90 days prior to screening visit (V1). The OAD(s) include any of the following anti-diabetic drug(s)/regimen: a. Biguanides (metformin? 1500 mg or maximum tolerated dose documented in the subject medical record) b. Other OADs (? half of the maximum approved dose according to local label or maximum tolerated dose as documented in subject medical record): i. Insulin secretagogues (SU and glinides) ii. DPP-4 inhibitors iii. alpha glucosidase inhibitors iv. SGLT-2 inhibitors v. Oral combination products (of the allowed individual OADs) 6. HbA1c % (53-86 mmol/mol) (both inclusive) by central laboratory analysis 7. Body mass index (BMI)? 45.0 kg/m2 8. Ability and willingness to adhere to the protocol including self-measurement of plasma page 5 / 7

6 glucose according to the protocol" Exclusion Criteria Details Exclusion Criteria "1. Known or suspected hypersensitivity to trial product(s) or related products 2. Previous participation in this trial. Participation is defined as signed informed consent 3. Female who is pregnant, breast-feeding or intends to become pregnant or is of child-bearing potential and not using adequate contraceptive methods (adequate contraceptive measures as required by local regulation or practice) 4. Participation in any clinical trial of an approved or non-approved investigationalmedicinal product within four weeks prior to the day of screening (V1) 5. Any chronic disorder or severe disease which, in the opinion of the investigator, might jeopardise subject s safety or compliance with the protocol 6. Acute decompensation of glycaemic control requiring immediate intensification of treatment to prevent severe metabolic dysregulation (e.g. diabetes ketoacidosis)? 90 days prior to the day of the screening 7. Any of the following: myocardial infarction, stroke or hospitalization for unstable angina or transient ischaemic attack within the past 180 days prior to the day of screening and between screening and randomisation 8. Subjects presently classified as being in New York Heart Association (NYHA) Class IV 9. Planned coronary, carotid or peripheral artery revascularisation known on the day of screening 10. Renal impairment measured as estimated Glomerular Filtration Rate (egfr) value of ml/min/1.73 m2 as defined by KDIGO 2012 classification using isotope dilution mass spectrometry (IDMS) for serum creatinine measured at screening 11. Impaired liver function, defined as ALT? 2.5 times upper normal limit (UNL) at screening 12. Inadequately treated blood pressure defined as Grade 3 hypertension or higher (Systolic?180 mmhg or diastolic?110 mmhg) at screening 13. Treatment with any medication for the indication of diabetes or obesity other than stated in the inclusion criteria in a period of 90 days before the day of screening 14. Anticipated initiation or change in concomitant medications (for more than 14 consecutive days) known to affect weight or glucose metabolism (e.g. treatment with orlistat, thyroid hormones, or corticosteroids) 15. Proliferative retinopathy or maculopathy requiring acute treatment. Verified by fundus photography or dilated fundoscopy performed within 90 days prior to randomisation 16. Presence or history of malignant neoplasms within the past five years prior to the day of screening. Basal and squamous cell skin cancer and any carcinoma in-situ are allowed" page 6 / 7

7 Powered by TCPDF ( Method of Generating Random Sequence Method of Concealment Blinding/Masking Computer generated randomization Centralized Open Label Primary Outcome Outcome Timepoints Change from baseline in glycosylated haemoglobin (HbA1c) (%) week 0 to week 26 Secondary Outcome Outcome Timepoints Target Sample Size Change from baseline in HbA1c (%) after 38 weeks Responder (Yes/No) for HbA1c after 38 weeks: o HbA1c (less than 7% o HbA1c less than 7% without nocturnal (00:01-05:59) BG confirmed symptomatic hypoglycaemia Change from baseline in fasting plasma glucose (FPG) after 38 weeks Self-measured plasma glucose measurements (SMPG) after 38 weeks Mean pre-breakfast measurements used for titration 9-point profile Phase of Trial Phase 3 Date of First Enrollment () Date of First Enrollment (Global) Estimated Duration of Trial Recruitment Status of Trial (Global) Recruitment Status of Trial () Publication Details Brief Summary Post-prandial increments Total Sample Size=528 Sample Size from =80 09/01/ /09/2016 Years=1 Months=0 Days=0 Completed Completed after 38 weeks after 38 weeks This trial is conducted in Algeria, Czech Republic,, Russia, Serbia, Turkey & United States of America. The once daily versus insulin glargine once daily in combination with insulin aspart once daily in controlling glycaemia basal insulin with or without oral antidiabetic treatment in need of treatment intensification. page 7 / 7