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CTRI Number  CTRI/2015/08/006139 [Registered on: 27/08/2015] 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 Trial 
Public Title of Study   A Study to Compare Insulin Intensification of Biphasic Insulin Aspart 30 and Insulin Analogues (Insulin Glargine and Insulin Aspart) in Insulin naïve Type 2 Diabetic Patients 
Scientific Title of Study   A 32-week Randomised, Multinational, Treat-to-target, Open Label, Parallel Group Comparison of Stepwise Insulin Intensification of Biphasic Insulin Aspart (BIAsp) 30 and Basal-bolus Therapy With Insulin Glargine and Insulin Aspart in Insulin naïve Type 2 Diabetic Patients Inadequately Controlled on Oral Anti-diabetic Therapy 
Trial Acronym   
Secondary IDs if Any  
Secondary ID  Identifier 
2014-003708-62  EudraCT 
BIASP-4157 Version 1.0 dated 18 Dec 2014  Protocol Number 
U1111-1158-7280  UTN 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name   
Designation   
Affiliation   
Address 




 
Phone    
Fax    
Email    
 
Details of Contact Person
Scientific Query
Modification(s)  
Name  Dr M V Srishyla 
Designation  Director-Clinical Medical,Regulatory and Quality 
Affiliation  Novo Nordisk India Private Ltd 
Address  Plot No.32, 47 - 50 EPIP Area, Whitefield

Bangalore
KARNATAKA
560 066
India 
Phone  918861082266  
Fax    
Email  mvsr@novonordisk.com  
 
Details of Contact Person
Public Query
Modification(s)  
Name  Dr Ramesh Jagannathan 
Designation  Head Clinical Operations  
Affiliation  Novo Nordisk India Private Ltd  
Address  Plot No.32, 47 - 50 EPIP Area, Whitefield Bangalore

Bangalore
KARNATAKA
560 066
India 
Phone  919632151938  
Fax    
Email  rjg@novonordisk.com  
 
Source of Monetary or Material Support  
Novo Nordisk AS C/O Novo Nordisk India Private Ltd. Plot No.32, 47 - 50, EPIP Area, Whitefield, Bangalore - 560 066 India  
 
Primary Sponsor  
Name  Novo Nordisk AS  
Address  c/o Novo Nordisk IPL,Plot No.32, 47 - 50,EPIP Area, Whitefield, Bangalore - 560 066 India  
Type of Sponsor  Pharmaceutical industry-Global 
 
Details of Secondary Sponsor  
Name  Address 
Nil  Nil 
 
Countries of Recruitment     Australia
Bulgaria
Hungary
India
Republic of Korea
Serbia
Thailand
Turkey
United Arab Emirates  
Sites of Study
Modification(s)  
No of Sites = 7  
Name of Principal Investigator  Name of Site  Site Address  Phone/Fax/Email 
Dr Arthur Joseph Asirvatham  Arthur Asirvatham Hospital  Ground floor, Clinical research department, Arthur Asirvatham Hospital,,No:42-A, Kuruvikaran Salai,
Madurai
TAMIL NADU 		 04522535266
04522531977
drajasirvatham@yahoo.co.in 
Dr Satish Babu K N  BGS Global Hospitals  BGS Global Hospitals, 1st Floor, Endocrinology department, BGS Health & Education City, #67, Uttarahalli Road, Kengeri, Bangalore-560 060, Karnataka India
Bangalore
KARNATAKA 		 9731533636
080-30444192
babu09_uk@yahoo.co.uk 
Dr Amit Patel  BSES Municipal General Hospital,  7th floor, Diabetology Research office,SV Road, Opp. Railway station, Andheri(WEST),
Mumbai (Suburban)
MAHARASHTRA 		 9920699789
912226715000
docamit79@gmail.com 
Dr Dukhabandhu Naik  Christian Medical College  810, 2nd floor,Department of Endocrinology, Diabetes and Metabolism, Christian Medical College,
Vellore
TAMIL NADU 		 9843671306
04164200854
drnaik2000@gmail.com 
Dr D Vijay Sekher Reddy  Gandhi Hospital,  Department of Endocrinology- Department of Endocrinology-HOD and Professor room, 3rd floor, Main building, Musheerabad, Secunderabad,
Hyderabad
ANDHRA PRADESH 		 9849172161
04027504441
drdvsreddyendo@Yahoo.com 
Dr Debmalya Sanyal  KPC Medical college and Hospital  Room no. 13, Block-1, Ground floor, Department of Endocrinology and Diabetology, 1F, Raja S.C. Mullick Road
Kolkata
WEST BENGAL 		 9830118388
-
drdebmalyasanyal@gmail.com 
Dr Anupam Prakash  Lady Harding Medical College & Smt. Sucheta Kriplani Hospital,  Room no. 1014, Department of Medicine, Old building,Lady Harding Medical College & Smt. Sucheta Kriplani Hospital,
New Delhi
DELHI 		 01123408278
01127662763
prakashanupam@hotmail.com 
 
Details of Ethics Committee
Modification(s)  
No of Ethics Committees= 7  
Name of Committee  Approval Status 
BSES Municipal General Hospital Ethics Committee;BSES Municipal General Hospital Ethics Committee, SV Road, Opp. Railway station, Andheri(WEST), Mumbai-400058 ;Dr. Amit Patel  Approved 
Ethics committee for human research;Lady Harding Medical college & Associated Hoapitals, Shahid Bhagat Singh Marg, New Delhi- 110001;Anupam Prakash  Approved 
Institutional Ethics Committee ( IEC) For Clinical Research;KPC Medical College and Hospital,1F Raja S.C. Mullick Road, Jadavpur, Kolkata-700032, West Bengal , India;Dr Debmalya Sanyal  Approved 
Institutional Ethics Committee- BGS Global Hospitals  Approved 
Institutional ethics committee;Arthur Asirvatham Hospital, No:42-A, Kuruvikaran Salai, Madhurai-635 ;Dr. Arthur Joseph Asirvatham  Approved 
Institutional ethics committee;Principal offices, Gandhi Medical College, Musheerabad, Secunderabad, Telangana-500003 ;Dr. D Vijay Sekher Reddy  Approved 
Institutional Review Board;Ethics committee Silver, Research Office, First floor, Carman block, Christian Medical College, Vellore   Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Approved/Obtained 
 
Health Condition / Problems Studied
Modification(s)  
Health Type  Condition 
Patients  Diabetes Mellitus, Type 2, (1) ICD-10 Condition: E11||Type 2 diabetes mellitus,  
 
Intervention / Comparator Agent  
Type  Name  Details 
Intervention  BIAsp  biphasic insulin aspart 30 Injected s.c./subcutaneously once daily with the largest meal Subjects should continue their pre-trial metformin and sulfonylurea dosages all throughout the trial(32 week) while other oral antidiabetic drugs will be discontinued. 
Comparator Agent  IGlar AND IAsp  Drug- insulin glargine Injected s.c./subcutaneously once daily at the same time every day, with the possibility of treatment intensification with insulin aspart (Basal-bolus arm) Subjects should continue their pre-trial metformin and sulfonylurea dosages all throughout the trial while other oral antidiabetic drugs will be discontinued. Drug- insulin aspart Injected s.c./subcutaneously once daily. Duration 32 weeks 
 
Inclusion Criteria  
Age From  18.00 Year(s)
Age To  99.00 Year(s)
Gender  Both 
Details  -18 Years and older
-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
-Male or female, age at least 18 years at the time of signing informed consent
-Type 2 diabetes subjects clinically diagnosed at least 6 months prior to screening
-Treatment with stable daily dose (for at least 90 days prior to screening) of: – Metformin (equal or above
1000 mg or maximum tolerated dose documented in the patient medical record) and – Sulfonylurea –
and willing to discontinue any other oral antidiabetic drugs containing insulin secretagogues, DPP4i
(dipeptidyl peptidase-4 inhibitor), SGLT2 (sodium glucose co-transporter 2), colesevelam, bromocriptin and/
or combination products at randomisation
-Insulin-naïve. Short term insulin treatment for acute illnesses for a total of 14 days or less is allowed as is
prior insulin treatment for gestational diabetes
-HbA1c (glycosylated haemoglobin) 7.0-9.5 % (both inclusive) analysed by central laboratory
-Willing to consume 3 main meals daily (morning, mid-day and evening) throughout the entire trial. The definition for ‘main meal’ will be according to the investigator’s discretion 
 
ExclusionCriteria 
Details  -Anticipated initiation or change in concomitant medications known to affect weight or glucose metabolism, in excess of 14 days (i.e. sibutramine, orlistat, thyroid hormones, systemic corticosteroids and other weight
loss/modifying agents)
-Impaired liver function, defined as ALT (alanine aminotransferase) at least 2.5 times upper limit of normal (central laboratory value measured at screening visit)
-Inadequately treated high blood pressure defined as Class 2 hypertension or higher (i.e. systolic blood pressure equal to or above 160 mm Hg or diastolic equal to or above 100 mm Hg) in accordance with the National High Blood Pressure Education Program, 7th Joint National Committee1 and ESH/ESC 2013 Guidelines2
-Within the past 180 days prior to randomisation, any of the following: Myocardial Infarction, stroke or hospitalization for unstable angina and /or transient ischemic attack 
 
Method of Generating Random Sequence   Computer generated randomization 
Method of Concealment   On-site computer system 
Blinding/Masking   Open Label 
Primary Outcome  
Outcome  TimePoints 
Change in HbA1c  Week 0, Week 32 
 
Secondary Outcome  
Outcome  TimePoints 
HbA1c below 7.0% without severe hypoglycaemic episodes  After 32 weeks of treatment 
Number of treatment emergent hypoglycaemic episodes  Weeks 0-32 
Total daily insulin dose  Weeks 0-32 
 
Target Sample Size   Total Sample Size="336"
Sample Size from India="46" 
Final Enrollment numbers achieved (Total)= "304"
Final Enrollment numbers achieved (India)="61" 
Phase of Trial   Phase 4 
Date of First Enrollment (India)   01/09/2015 
Date of Study Completion (India) 21/09/2016 
Date of First Enrollment (Global)  01/09/2015 
Date of Study Completion (Global) 21/09/2016 
Estimated Duration of Trial   Years="1"
Months="5"
Days="0" 
Recruitment Status of Trial (Global)
Modification(s)  		 Completed 
Recruitment Status of Trial (India)  Completed 
Publication Details   None yet 
Individual Participant Data (IPD) Sharing Statement

Will individual participant data (IPD) be shared publicly (including data dictionaries)?  

Brief Summary  

This trial is conducted globally. The aim of this trial is to compare stepwise insulin intensification of biphasic insulin aspart (BIAsp) 30 and basal-bolus therapy with insulin glargine and insulin aspart in insulin naïve type 2 diabetic patients inadequately controlled on oral anti-diabetic therapy.

 
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