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Clinical Trial Details (PDF Generation Date :- Thu, 30 Sep 2021 23:47:06 GMT)

CTRI Number CTRI/2012/10/003041 [Registered on: 05/10/2012] - Trial Registered Prospectively Last Modified On 29/11/2018 Post Graduate Thesis No Type of Trial Interventional Type of Study Drug Study Design Randomized, Parallel Group, Active Controlled Trial Public Title of Study Treatment with biphasic insulin aspart 30 in subjects who are currently using at least sitagliptin and metformin to manage their type 2 diabetes Scientific Title of A 24 week randomised, open label, 3 parallel-group comparison of once and twice daily biphasic Study insulin aspart (BIAsp) 30 plus sitagliptin and twice daily BIAsp 30, all in combination with metformin in insulin naïve type 2 diabetic subjects inadequately controlled on sitagliptin and metformin Secondary IDs if Any Secondary ID Identifier 2011-004930-33 EudraCT BIASP-3963 Ver 1.0 dated 25 Nov 2011 Protocol Number NCT01519674 ClinicalTrials.gov U1111-1125-0850 Other Details of Principal Details of Principal Investigator Investigator or overall Name Dr Prof Debasish Maji Trial Coordinator (multi-center study) Designation Principal Investigator Affiliation Calcutta Diabetes and Endocrine Foundation Address Diabetes and Endocrine clinic 11/7A, J.K. Pal road Kolkata WEST BENGAL 700038 Phone 919830109775 Fax 913324785976 Email [email protected] Details Contact Details Contact Person (Scientific Query) Person (Scientific Name Dr Raman Shetty Query) Designation Director-Clinical Medical and Regulatory Affiliation Novo Nordisk India Private Ltd. Address Plot No.32, 47 - 50, EPIP Area, Whitefield, - 560 066 India Bangalore 560 066 India Phone 918040303200 Fax 91804119026 Email [email protected] Details Contact Details Contact Person (Public Query) Person (Public Query) Name Mr Avik Kumar Gosh Designation Senior Clinical Operations Manager Affiliation Novo Nordisk India Private Ltd Address Plot No.32, 47 - 50, EPIP Area, Whitefield, Bangalore - 560 066 Bangalore KARNATAKA 560 066

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India Phone 918040303200 Fax 91804119026 Email [email protected] Source of Monetary or Source of Monetary or Material Support Material Support > Novo Nordisk India Private Limited Primary Sponsor Primary Sponsor Details Name Novo Nordisk India Private Limited Address Novo Nordisk India Private Ltd. Plot No.32, 47 - 50, EPIP Area, Whitefield, Bangalore - 560 066 India Type of Sponsor Pharmaceutical industry-Global Details of Secondary Name Address Sponsor NIL NIL Countries of List of Countries Recruitment Argentina Australia Brazil Greece India Malaysia Republic of Korea Thailand Turkey Sites of Study Name of Principal Name of Site Site Address Phone/Fax/Email Investigator Dr Vijayam Balaji "Dr. V. Seshaiah #729, P .H. Road, 9841081010 Diabetes Research Aminjikarai" 914426640660 Institute & Chennai [email protected] TAMIL NADU m Dr D Shantharam Apollo Hospitals Flat No 16/1 and 17/1, 9940343333 Education and 2nd Floor, Krishnadeep 914428294449 Research Foundation Chambers (Apollo duvuru_shantharam@y Annexe), No.1, Wallace ahoo.co.in Garden, Thousand Lights," Chennai TAMIL NADU Dr Paramesh Bangalore Clinisearch No 416, 4th Cross, 2nd 9845010610 Shammanna Block, Kalyan Nagar" 918025459006 Bangalore [email protected] KARNATAKA m Dr Prof Debasish Maji Calcutta Diabetes and 11/7A, J.K. Pal road 919830109775 Endocrine Foundation Kolkata 913323965976 WEST BENGAL [email protected] Dr MKMukhopadhyay Diabetic Clinic and 46A, Ritchie Road. 919830203242 Research Centre Kolkata 913340696196 WEST BENGAL mkmukhopadhyay@ya hoo.co.in Dr Punit Arora Diabetic Clinic and 171-Green Avenue 91988000919 Research Institute Amritsar 911832500919 PUNJAB [email protected] Dr Anuradha Diabetomics India Pvt 6-3-349/17B Hindi 919346011998

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Ltd Nagar, Behind 914023357111 Panjagutta Saibaba [email protected] Temple, Banjara Hills" m Hyderabad ANDHRA PRADESH Dr V Reddy Gandhi Hospital and & Musheerabad,Secunder 9849172161 Medical college abad. 04027504441 Hyderabad [email protected] ANDHRA PRADESH m Dr Subhod Chandra Kailash Hospital H – 33, Sector 27,Noida 919810025400 Gautam Buddha Nagar 911202441414 UTTAR PRADESH [email protected] m Dr Sreenivas Murthy Lifecare Clinic and # 2253, MCN Complex, 919448051046 Researech Centre Main Road, 918023630055 Sahakara Nagar" [email protected] Bangalore KARNATAKA Dr Vimal Malabar Institute of Mini By-Pass Road, 09895298705 Medical Sciences Ltd Govindapuram P.O 914952741329 Kozhikode vimalnambiar78@gmail KERALA .com Dr Arpandev Manipal Hospital 98, HAL Airport Road, 919886051410 Bhattacharyya Bangalore 08025207181 KARNATAKA arpan@diabetesendocri nology.in Dr Deepak Lal M R.M. Diabetes AA2, 2nd Avenue, 919790928158 Chhabria Education & Research (Round Tana) Anna 914426211919 Foundation, Nagar, madhavdiabetes.centre Chennai @yahoo.com TAMIL NADU Dr Rishi Shukla Regency Hospital A-2, Savotayanagar," 919415042286 Limited Kanpur Nagar 915122541696 UTTAR PRADESH [email protected] m Dr Jayanthy RameshS Sais Institute of # 8-2-626/B, Krishna 919948145445 Endocrinology Athreya, Road No. 11, 914023310021 Lane Opp. Care drjayanthyramesh@gm Banjara Hospital, ail.com Banjara Hills" Hyderabad ANDHRA PRADESH Dr Sunil Gupta Sunils Diabetes Care 42, Lendra Park, 919823152111 n’ Research Centre Ramdaspeth 917122428555 Pvt. Ltd. Nagpur drsgupta_ngp@rediffm MAHARASHTRA ail.com Dr Tiven Marwah VS Hospital Ground floor,Ellis 9824055857 Bridge cross road Ellis 7926577647 Bridge,Ahmedabad. dhara.thaker@cytespac Ahmadabad e.com GUJARAT Details of Ethics Name of Committee Approval Status Date of Approval Is Independent Ethics Committee Committee? Bangalore Central Approved 04/06/2012 Yes Ethics Committee Cerebral Independent Approved 12/06/2012 Yes Review Board 301/A,

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Lenaine Estate, Abids, Hyderabad - 500001Dr Jayanthy Ramesh Ethics Committee - Approved 25/04/2012 No Apollo Hospitals,Apollo Hospitals Enterprise Ltd.21, Greams Lan, Off Greams Road,Chennai -600006,Dr D Shantharam Ethics Committee Of Approved 11/06/2012 No Diabetes Care n’ Research Centre,"Sunils Diabetes Care n’ Research Centre Pvt. Ltd,42, Lendra Park, Ramdaspeth,Nagpur - 440010,Dr Sunil Gupta Ethics Committee of Approved 14/03/2012 No Manipal Hospital,6th Floor, 98, HAL Airport Road,Dr Arpandev Bhattacharyya Ethics Committee Approved 16/05/2012 No Regency Hospital LTD,A-2, Sarvodaya Nagar, Kanpur - 208005,Dr Rishi Shukla Ethics CommitteeDr. V Approved 28/05/2012 No Seshiah Diabetes Research Inistute,Dr. Balaji Diabetes Care CentreNo.:729, P.H Road, Aminjikari, Chennai - 600029DrVijayam Balaji Human Ethics Approved 02/01/2013 No Committee,Gandhi Hospital, Secunderabad, Independent Ethics Approved 17/07/2012 Yes Committee Ludhiana,No. 5, 2nd Floor, Block C, Rishi Nagar, Ludhiana 141001,Dr. Punit Arora Independent Ethics Approved 14/06/2012 Yes Committee,Kolkata 169 Rajdanga Main Road Kolkata 700107,Dr. M.K.Mukhopadhyay Independent Ethics Approved 14/06/2012 Yes Committee,Kolkata 169 Rajdanga Main Road Kolkata 700107,Dr. Prof. Debasish Maji

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Independent Approved 15/05/2012 Yes Ethics,AA2, Anna Nagar, Chennai - 600040,Dr M. C. Deepak Kailash Hospital Ethics Approved 09/04/2012 No Committee, H-33, Sector 27,Noida - 201301 Uttar Pradesh,Dr. Subhod Chandra Lifecare Ethics Approved 25/05/2012 No Committee#2253, M.C.N. Complex, Kodigehalli Main Road, Sahakara Nagar, Bangalore - 560092Dr Sreenivas Murthy Malabar Institute of Approved 09/07/2012 No Medical Science Ltd P. O.Govindapuram,Calicu t-673016Dr Vimal NHL Institutional Ethics Approved 20/02/2013 No Committee,V S Hospital, Ahmedabad,Dr Tiven Marwah Sameeksha Approved 15/06/2012 Yes Independent Ethics CommitteeH. No. 6-3-609/15, Anand Nagar Colony, Khairatabad, Hyderabad - 500004Dr Anuradha Regulatory Clearance Status Date Status from DCGI Approved/Obtained 01/10/2012 Health Condition / Health Type Condition Problems Studied Patients Diabetes Mellitus, Type 2 Patients Type 2 diabetes mellitus Intervention / Type Name Details Comparator Agent Intervention BIAsp 30 twice daily + sitagliptin Drug: biphasic insulin aspart 30. + metformin BIAsp 30 will be injected subcutaneously (under the skin) twice daily. Individually adjusted dose. Drug: sitagliptin. Subjects will continue on their pre-trial sitagliptin treatment. Drug: metformin. Subjects will continue on their pre-trial metformin treatment. Comparator Agent BIAsp 30 twice daily + Drug: biphasic insulin aspart 30. metformin BIAsp 30 will be injected subcutaneously (under the skin) twice daily. Individually adjusted dose. Drug: metformin. Subjects will continue on their pre-trial

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metformin treatment Comparator Agent BIAsp 30 once daily + sitagliptin Drug: biphasic insulin aspart 30. + metformin BIAsp 30 will be injected subcutaneously (under the skin) once daily. Individually adjusted dose. Drug: sitagliptin. Subjects will continue on their pre-trial sitagliptin treatment. Drug: metformin. Subjects will continue on their pre-trial metformin treatment Inclusion Criteria Inclusion Criteria Age From 18.00 Year(s) Age To 99.00 Year(s) Gender Both Details Diagnosed with type 2 diabetes for a minimum of 6 months prior to screening (Visit 1)
Stable treatment with a total daily dose of at least 1000 mg of metformin (with or without additional oral anti-diabetic drugs (OADs) treatment). The metformin dose must have been unchanged for at least 3 months prior to screening (Visit 1)
Stable treatment with a total daily dose of at least 100 mg sitagliptin. The sitagliptin dose must have been unchanged for at least 3 months prior to screening (Visit 1)
Subject is insulin-naïve (never previously treated with insulin). (However, short term insulin use due to intermittent illness of up to 14 days or insulin treatment for gestational diabetes is allowed)
HbA1c (glycosylated haemoglobin) between 7.0 to 10.0 % (53-86 mmol/mol) (both inclusive) by central laboratory analysis demonstrating inadequate control on sitagliptin and metformin (with or without other OADs)
Body Mass Index (BMI) below or equal to 40.0 kg/m2
Able and willing to eat at least 2 meals (breakfast and dinner) every day during the trial
No Upper age limit Specified Exclusion Criteria Exclusion Criteria Details Treatment with thiazolidinedione (TZD) or glucagon-like-peptide-1 (GLP-1) receptor agonist within the last 3 months prior to screening (Visit 1) Cardiac disease within the last 6 months prior to screening (Visit 1), defined as: decompensated heart failure New York Heart Association (NYHA) class III or IV; unstable angina pectoris; or myocardial infarction Severe hypertension, systolic blood pressure equal to or above 180 mm Hg or diastolic blood pressure equal to or above 100 mm Hg, after 5 minutes rest in the sitting position using mean value of 3 measurements at screening (Visit 1) Anticipated change of dose of any systemic treatment with products, which in the trial physician’s opinion could interfere with glucose metabolism (e.g., systemic corticosteroids) Clinically significant diseases (except for conditions associated with type 2 diabetes) which, in the trial physicians opinion may confound the results of the trial or pose additional risk in administering trial product(s) Impaired hepatic function as indicated by aspartate aminotransferase (ASAT) or alanine aminotransferase (ALAT) above 2.5 times the upper normal range, according to central laboratory reference ranges Impaired renal function as indicated by serum creatinine levels equal to or above 133 micromol/L (1.5 mg/dL) for males and equal to or above 124 micromol/L (1.4 mg/dL) for females or estimated creatinine clearance below 60 mL/min, based on the Cockroft &

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Gault formula and according to local practise for metformin use Method of Generating Computer generated randomization Random Sequence Method of Centralized Concealment Blinding/Masking Open Label Primary Outcome Outcome Timepoints Change from baseline in HbA1c Change from baseline in HbA1c Secondary Outcome Outcome Timepoints Responder for HbA1c, proportion of subjects After 24 weeks of treatment achieving pre-defined HbA1c targets. Change from baseline in fasting plasma glucose Week 0, week 24

Prandial plasma glucose (PPG) increments at After 24 weeks of treatment each meal (breakfast, lunch and dinner) and overall mean increment. Adverse Events Weeks 0-24

Number of treatment emergent hypoglycaemic Weeks 0-24 episodes (nocturnal and day-time) classified both according to the American Diabetes Association (ADA) definition and to an additional definition for minor episodes. Change from baseline in Patient Reported Week 0, week 24 Outcome by use of the Treatment Related Impact Measure - Diabetes Target Sample Size Total Sample Size=573 Sample Size from India=190 Final Enrollment numbers achieved (Total)=582 Final Enrollment numbers achieved (India)=162 Phase of Trial Phase 4 Date of First 15/10/2012 Enrollment (India) Date of First 05/06/2012 Enrollment (Global) Estimated Duration of Years=1 Trial Months=6 Days=15 Recruitment Status of Completed Trial (Global) Recruitment Status of Completed Trial (India) Publication Details NA Brief Summary The trial BIASP-3963 is conducted in Asia, Europe, Oceania and South America. The aim of this clinical trial is to generate data demonstrating how to intensify diabetes treatment using BIAsp 30 (biphasic insulin aspart 30) by adding or substituting BIAsp 30 to sitagliptin in various regimens for type 2 patients inadequately controlled on sitagliptin and metformin (with or without other oral anti-diabetic drugs (OADs)). The trial is conducted as a phase 4 trial in the majority of the participating countries. However, in some countries the trial is conducted as phase 3b.The recruitment is expected to start by 05 June 2012 globally.The study was open for recruitment on 05 Oct 2012 in India.

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