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1 Clinical Trial Details (PDF Generation Date :- Tue, 16 Apr :04:45 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/2011/12/ [Registered on: 15/12/2011] - Trial Registered Retrospectively No Interventional Drug Randomized, Parallel Group, Active Controlled Trial Comparison of biphasic insulin aspart 30 individually adjusted by the subject and the trial physician, respectively, both combined with metformin in subjects with type 2 diabetes A 20 week randomised, multinational, open labelled, 2 armed, parallel group comparison of twice daily subjectdriven titration of biphasic insulin aspart (BIAsp) 30 versus twice daily investigator-driven titration of biphasic insulin aspart (BIAsp) 30 both in combination with metformin in subjects with type 2 diabetes inadequately controlled on basal insulin analogues Secondary IDs if Any Secondary ID Identifier Details of Principal Investigator or overall Trial Coordinator (multi-center study) Details Contact Person (Scientific Query) Details Contact Person (Public Query) EudraCT BIAsp 3878 NCT U Protocol Number ClinicalTrials.gov UTN Details of Principal Investigator Dr Jyothydev Keshavdev Principal Investigator Phone Fax Jothydevs Diabetes & Research Center JDC Junction, Road, Muduvanmugal, Konkalam Thiruvananthapuram KERALA jothydev@gmail.com Details Contact Person (Scientific Query) Dr Raman Shetty Phone Fax Clinical operations Director Novo Nordisk Private Ltd. Plot No.32, 47-50, EPIP Area, Whitefield, Bangalore rasy@novonordisk.com Details Contact Person (Public Query) Mr Avik Kumar Gosh Senior Clinical Operations Manager Novo Nordisk Private Ltd. Plot No.32, 47-50, EPIP Area, Whitefield, Bangalore page 1 / 5

2 Source of Monetary or Material Support Primary Sponsor Details of Secondary Sponsor Countries of Recruitment Sites of Study Phone Fax > Novo Nordisk Private Limited Type of Sponsor NIL List of Countries Argentina China Poland Turkey United Kingdom of Principal Investigator Dr Sanjay Chatterjee Dr Neeta Deshpande Source of Monetary or Material Support Primary Sponsor Details Novo Nordisk Private Limited Novo Nordisk Private Ltd. Plot No.32, 47-50, EPIP Area, Whitefield, Bangalore Pharmaceutical industry-global NIL of Site Site Phone/Fax/ Apollo Gleneagles Hospitals Belgaum Diabetes 58, Canal Circular Road Kolkata West Bengal, Kolkata WEST BENGAL Belgaum Diabetes,Maruti Galli, Near Mahila Vastu Bhandar Belgaum , Karnataka Belgaum Dr Hemant P Thacker Bhatia Hospital G -1 Ward, Tardeo Road Mumbai Maharashtra, Mumbai MAHARASHTRA Dr Banshi Saboo Dr Jothydev Diacare Diabetes Jothydevs Diabetes & Research Center 1&2 Gandhi Park, Near Nehru Nagar Cross Roads, Ambawadi, Ahmedabad Gujrat, Ahmadabad GUJARAT JDC Junction, Muduvanmugal, Konkalam Road Thiruvananthapuram Kerala, sanjay_doc@yahoo.co m neetarohit@gmail.com drhpt@hotmail.com banshisabo@hotmail.co m jothydev@gmail.com page 2 / 5

3 Details of Ethics Committee Dr Girithar Gopalakrishna Dr Rajeev Chawla Dr Nallaperumal K G Hospital and Post Graduate Institute North Delhi Diabetes Center, Swamy Diabetes Thiruvananthapuram KERALA Department of Diabetology, Arts College Road, Coimbatore Tamilnadu, Coimbatore TAMIL NADU 180, Jai Apartments, Sector - 9 Rohini, Delhi North West DELHI No. 175, R K Mutt Road, Mandaveli Chennai Tamilnadu, Chennai TAMIL NADU drgirimd@yahoo.com rajeevaastikchawla@ya hoo.com swamydiabetes@gmail. com of Committee Approval Status Date of Approval Is Independent Ethics Committee? Apollo Gleneagles Institutional Ethics Committee,58, Canal Circular Road,DR SANJAY CHATERJEE Clinical Trial Ethics Committee - Bhatia Hospital,G -1 Ward, Tardeo Road,DR HEMANT THACKER Approved 24/09/2011 No Approved 31/10/2011 No College,Bangalore,DR NALLAPERUMAL Approved 05/08/2011 No College,Bangalore,DR NEETHA DESPANDE Approved 14/10/2011 No College,Bangalore.DR BANSI SABOO Approved 13/10/2011 No Institutional Ethics Committee Jothydevs Diabetes and Research Thiruvananthapu ramdr JYOTHIDEV Regional Ethics Commit teecoimbatore,tamil Nadu,DR GIRITHAR GOPALAKRISHNA SPECT ERB,503, NDM 2, Netaji Subhash Approved 31/08/2011 No Approved 24/08/2011 Yes Approved 26/08/2011 Yes page 3 / 5

4 Regulatory Clearance Status from DCGI Health Condition / Problems Studied Intervention / Comparator Agent Inclusion Criteria Exclusion Criteria Place,DR RAJEEV CHAWALA Status Date Approved/Obtained 25/11/2011 Health Type Patients Patients Condition Type 2 Diabetes Mellitus Type 2 diabetes mellitus Type Details Intervention Comparator Agent Age From Age To Gender Details Details biphasic insulin aspart 30Subject-driven group (Experimental biphasic insulin aspart 30Investigator-driven group (Active Comparator) Year(s) Year(s) Both Inclusion Criteria Administered subcutaneously (under the skin) using FlexPen twice daily for 20 weeks. Directions for use will be given to each subject at each dispensing visit. Subjects will continue on their pre-trial metformin dose. Any previous basal insulin analogue and OAD (oral anti-diabetes drug) treatments (except for metformin) will be discontinued Administered subcutaneously (under the skin) using FlexPen twice daily for 20 weeks. Directions for use will be given to each subject at each dispensing visit. Subjects will continue on their pre-trial metformin dose. Any previous basal insulin analogue and OAD (oral anti-diabetes drug) treatments (except for metformin) will be discontinued Diagnosed with type 2 diabetes for a minimum of 12 months prior to Visit 1 (screening) Currently treated with a basal insulin analogue for at least 3 months prior to Visit 1 (screening) Stable treatment (no change in dose or regimen) with a total daily dose of at least 1500 mg metformin or maximum tolerated dose (minimum 1000 mg) ± additional OAD treatment. The metformin treatment must have been stable for at least 2 months prior to Visit 1 (screening) HbA1c higher or equal to 7.0% and below or equal to 10.0% (one re-test within one week of screening visit is allowed. The last sample will be conclusive) Body Mass Index (BMI) below or equal to 40.0 kg/m2 Able and willing to eat at least 2 main meals each day during the trial Able and willing to adhere to the protocol including compliance with performance of self measured plasma glucose (SMPG), injection regimen and titrating themselves according to the protocol Experience in performing self measured plasma glucose (SMPG) Exclusion Criteria Treatment with any thiazolidinedione (TZD) and glucagon-like page 4 / 5

5 Powered by TCPDF ( Method of Generating Random Sequence Method of Concealment Blinding/Masking Computer generated randomization On-site computer system Open Label peptide-1 (GLP-1) receptor agonists or pramlintide within the last 3 months prior to Visit 1 (screening) Impaired hepatic function defined as alanine aminotransferase (ALAT) above or equal to 2.5 times upper referenced limit (one re-test within one week of screening visit is allowed. The last sample will be conclusive) Impaired kidney function with serum creatinine above or equal to 133 µmol/l (1.5 mg/dl) for males and above or equal to 124 µmol/l (1.4 mg/dl) for females (one re-test within one week of screening visit is allowed. The last sample will be conclusive) Cardiac problems or uncontrolled treated/untreated severe hypertension (defined as systolic blood pressure higher or equal to 180 mmhg and/or diastolic blood pressure higher or equal to 100 mmhg) Previous use of pre-mixed insulin products (pre-mixed insulin analogues or pre-mixed human preparations) Primary Outcome Outcome Timepoints Change in HbA1c (glycosylated haemoglobin) Time frame: Week 0, week 20 Secondary Outcome Outcome Timepoints Change in fasting plasma glucose (FPG) (central laboratory values). Time frame: Week 0, week 20 Number of hypoglycaemic episodes. Time frame: from week 0 to week 20 Patient Reported Outcomes evaluated: Treatment-Related Impact Measures for Diabetes (TRIM-D). Time frame: Weeks 0, 4 and 20 Target Sample Size Phase of Trial Phase 4 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 Total Sample Size=338 Sample Size from =90 28/11/ /09/2011 Years=1 Months=1 Days=1 Completed Completed Not applicable This trial is conducted in Asia, Europe and South America. The aim of this trial is to confirm efficacy of subject-driven titration (individually adjusted) of biphasic insulin aspart 30 twice daily in terms of glycaemic control assessed by change in glucosylated haemoglobin (HbA1c). page 5 / 5