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CTRI Number  CTRI/2010/091/000623 [Registered on: 08/09/2010]
Last Modified On: 13/11/2018
Post Graduate Thesis  No 
Type of Trial  Interventional 
Type of Study
Modification(s)  		 Drug 
Study Design  Randomized, Parallel Group, Active Controlled Trial 
Public Title of Study
Modification(s)  		 A trial is to compare the efficacy and safety of NN5401 insulin degludec and insulin aspartIDegAsp with insulin glargine IGlar both as add on to subjects ongoing treatment with metformin and at least one OAD oral anti diabetic drug  
Scientific Title of Study
Modification(s)  		 An extension trial comparing safety and efficacy of NN5401 with insulin glargine in subjects with type 2 diabetes (BOOST START 1) 
Trial Acronym   
Secondary IDs if Any  
Secondary ID  Identifier 
2009-015839-33  EudraCT 
NCT01169766  ClinicalTrials.gov 
NN5401-3726  Protocol Number 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
Modification(s)  
Name  Dr Ajay Kumar 
Designation  Principal Investigator 
Affiliation  Diabetes Care & Research Centre 
Address  Diabetes Care & Research Centre
G.C -1B, Near Overbridge
Not Applicable
N/A
800020
India 
Phone  0612-2350434  
Fax  0612-2357332  
Email  drajaykr@yahoo.com  
 
Details of Contact Person
Scientific Query
Modification(s)  
Name  Dr Ramesh Jagannathan 
Designation  Principal Investigator 
Affiliation  Novo Nordisk India Private Limited.  
Address  Novo Nordisk India Private Ltd.
Plot No.32, 47 - 50,EPIP Area, Whitefield,
Bangalore
KARNATAKA
560 066
India 
Phone  919632151938  
Fax  918041119026  
Email  rjg@novonordisk.com  
 
Details of Contact Person
Public Query
Modification(s)  
Name  Mr Avik Kumar Ghosh 
Designation  Head Clinical operations 
Affiliation   
Address  Novo Nordisk India Private Ltd.
Plot No.32, 47 - 50,EPIP Area, Whitefield,
Bangalore
KARNATAKA
560 066
India 
Phone  919731188991  
Fax  918041119026  
Email  avkg@novonordisk.com  
 
Source of Monetary or Material Support
Modification(s)  
Novo Nordisk A/S c/o Novo Nordisk India Private Ltd. Plot No.32, 47 - 50, EPIP Area, Whitefield, Bangalore - 560 066 India  
 
Primary Sponsor
Modification(s)  
Name  Novo Nordisk AS  
Address  Novo Allé2880 BagsværdDENMARKTel: +45 4444 8888Fax: +45 4449 0555Corporate Communications: Novo Nordisk India Private LimitedPlot No. 32, 47-50,EPIP Area, Whitefield,Bangalore - 560 066. IndiaTelephone no. : +91 80 40303200Fax no. : +91 80 41123518  
Type of Sponsor  Pharmaceutical industry-Global 
 
Details of Secondary Sponsor  
Name  Address 
NIL   
 
Countries of Recruitment     India  
Sites of Study
Modification(s)  
No of Sites = 7  
Name of Principal Investigator  Name of Site  Site Address  Phone/Fax/Email 
Dr Unnikrishnan AG  Amrita Institute of Medical Sciences  Elamakkara (P.O),-682036
Ernakulam
KERALA 		 0484-2802084
04842802084
unnikrishnanag@aims.amrita.edu 
Dr Ajay Kumar  Diabetes Care & Research Centre  G.C -1B, Near Overbridge,Kankarbagh-800020
Patna
BIHAR 		 0612-2350434
0612-2357332
drajaykr@yahoo.com  
Dr S K Sharma  Diabetes, Thyroid & Research Centre  11, Shivaji Nagar , Civil lines,-302016
Jaipur
RAJASTHAN 		 0141-2229202
0141-2221598
sksharma7@gmail.com 
Dr Manoj Chawla  Lina Diabetes Care Centre  003/, Yashodan Appartments , Four Bunglows Jn., J.P. Road,Andheri(W)-400053
Mumbai
MAHARASHTRA 		 022-26302288
022-26302623
dr_manoj@hotmail.com 
Dr Arpandev Bhattacharyya  Lotus Diagnostic Centre  No 493, CMH Road , Indiranagar,-560038
Bangalore
KARNATAKA 		 080-25284000
080-25257500
arpan@diabetesendocrinology.in  
Dr Nallaperumal  Swamy Diabetes Centre  No 174, RK Mutt Road , Mandeveli,-600028
Chennai
TAMIL NADU 		 044-24615115
044-24684462
swamydiabetes@gmail.com  
Dr M Shunmugavelu  Trichy Diabetes Speciality Centre  B-37, Shastri Road,7th Cross Thillai nagar-620018
Tiruchirappalli
TAMIL NADU 		 0431-2742091
0431-4021782
msv_diab@sify.com 
 
Details of Ethics Committee
Modification(s)  
No of Ethics Committees= 7  
Name of Committee  Approval Status 
Clinicom, "Bhooma", No 7, 17 A Cross, Malleshwaram west, Bangalore- 560055 ( Dr Ajay Kumar)  Approved 
Clinicom, "Bhooma", No 7, 17 A Cross, Malleshwaram west, Bangalore- 560055 ( Dr Arpandev Bhattacharyya)  Approved 
Clinicom, "Bhooma", No 7, 17 A Cross, Malleshwaram west, Bangalore- 560055 ( Dr M Shunmugavelu)  Approved 
Clinicom, "Bhooma", No 7, 17 A Cross, Malleshwaram west, Bangalore- 560055 ( Dr Manoj Chawla)  Approved 
Clinicom, "Bhooma", No 7, 17 A Cross, Malleshwaram west, Bangalore- 560055 ( Dr Nallaperumal S)  Approved 
Clinicom, "Bhooma", No 7, 17 A Cross, Malleshwaram west, Bangalore- 560055( Dr SK Sharma)  Approved 
Institutional Ethics Committee, Amrita Institute of Medical Sciences & Research Center, Amrita Lane, Elamakkara, P.O. Kochi- 682036(Dr Unnikrishnan A G)  Approved 
 
Regulatory Clearance Status from DCGI
Modification(s)  
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
Modification(s)  
Type  Name  Details 
Comparator Agent  Insulin Glargine  Injected sub cutaneously under the skin once daily.Dose was individually adjusted Duration of the treatment will be 26 weeks 
Intervention  NN5401  Injected sub cutaneous under the skin once daily with the breakfast meal Dose was individually adjusted for duration of 26 weeks 
 
Inclusion Criteria
Modification(s)  
Age From  18.00 Year(s)
Age To  99.00 Year(s)
Gender  Both 
Details  -Informed consent obtained before any trial-related activities.
-Minimum 18years of age
-Must have completed the 26-week treatment period (Visit 28) in trial NN5401-3590
 
 
ExclusionCriteria 
Details  -Anticipated change in concomitant medication known to interfere significantly with glucose metabolism, such as systemic corticosteroids, beta-blockers, MAO inhibitors -Anticipated significant lifestyle changes during the trial, e.g. shift work (including permanent night/evening shift workers), as well as highly variable eating habits as judged by the physician) -Pregnancy, breast-feeding, the intention of becoming pregnant or not using adequate contraceptive measures according to local requirements  
 
Method of Generating Random Sequence   Computer generated randomization 
Method of Concealment   On-site computer system 
Blinding/Masking
Modification(s)  		 Open Label 
Primary Outcome  
Outcome  TimePoints 
Number of treatment emergent adverse events (AEs)  after 52 weeks of treatment (26 weeks of treatment in trial NN5401-3590 + 26 weeks of treatment in extension) 
 
Secondary Outcome  
Outcome  TimePoints 
Number of severe and minor treatment emergent hypoglycaemic episodes  after 52 weeks of treatment (26 weeks of treatment in trial NN5401-3590 + 26 weeks of treatment in extension) 
 
Target Sample Size
Modification(s)  		 Total Sample Size="360"
Sample Size from India="60" 
Final Enrollment numbers achieved (Total)= "413"
Final Enrollment numbers achieved (India)="58" 
Phase of Trial   Phase 3 
Date of First Enrollment (India)
Modification(s)  		 14/08/2010 
Date of Study Completion (India) 02/05/2011 
Date of First Enrollment (Global)  26/07/2010 
Date of Study Completion (Global) 04/05/2011 
Estimated Duration of Trial   Years="0"
Months="7"
Days="0" 
Recruitment Status of Trial (Global)
Modification(s)  		 Completed 
Recruitment Status of Trial (India)  Completed 
Publication Details
Modification(s)  		 No study results posted yet. 
Individual Participant Data (IPD) Sharing Statement

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

Brief Summary
Modification(s)  		 The first enrollement of patients in India is 19 Aug 2010 The number of patients to be recruited in India is 38 Duration of the trial is 28 weeks Duration of treatment with trial product is 26 weeks This is an extension of trial of NN5401-3590 Trial ( Ref: CTRI/2010/091/000044).The study is completed. 
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