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CTRI Number  CTRI/2010/091/000627 [Registered on: 06/08/2010]
Last Modified On: 26/07/2012
Post Graduate Thesis  No 
Type of Trial  Interventional 
Type of Study
Modification(s)  		 Biological 
Study Design  Randomized, Parallel Group, Active Controlled Trial 
Public Title of Study
Modification(s)  		 A clinical trial to study safety and efficacy of two drugs Insugen® R and Insugen® N with Actrapid® and Insulatard® in Patients with Type 1 Diabetes Mellitus.  
Scientific Title of Study
Modification(s)  		 A Randomized, Active Controlled, Parallel Group, Multicentre, Two-Phase, Open-Label Study Comparing the Safety and Immunogenicity of Insugen R and Insugen N with Actrapid and Insulatard in Patients with Type 1 Diabetes Mellitus 
Trial Acronym   
Secondary IDs if Any
Modification(s)  
Secondary ID  Identifier 
INSUGCT300509, Version 3.0; 08Nov2011  Protocol Number 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name   
Designation   
Affiliation   
Address 

Not Applicable
N/A

India 
Phone    
Fax    
Email    
 
Details of Contact Person
Scientific Query
Modification(s)  
Name  Dr Sarika Deodhar 
Designation  Medical Research Officer 
Affiliation  Biocon Research Limited 
Address  Clinical, Biocon Research Limited – SEZ Unit, Plot No: 2 & 3, Phase IV-BIA, Bommasandra-Jigani Link Road,

Bangalore
KARNATAKA
560 099
India 
Phone  08028085130  
Fax    
Email  Sarika.Deodhar@biocon.com  
 
Details of Contact Person
Public Query
Modification(s)  
Name  Rashika Suri 
Designation  Clinical Operations 
Affiliation  Biocon Research Limited 
Address  Clinical, Biocon Research Limited SEZ Unit Plot No: 2 & 3, Phase IV-BIA Bommasandra-Jigani Link Road Bangalore

Bangalore
KARNATAKA
560 099
India 
Phone  080-28085130  
Fax    
Email  Rashika.Suri@biocon.com  
 
Source of Monetary or Material Support
Modification(s)  
Biocon SA 
 
Primary Sponsor
Modification(s)  
Name  Biocon SA 
Address  Case postale 901 Rue de l’Avenir 12 CH 2800 Delémont 1 Switzerland 
Type of Sponsor  Pharmaceutical industry-Indian 
 
Details of Secondary Sponsor  
Name  Address 
NIL   
 
Countries of Recruitment
Modification(s)  		   India
Germany
Hungary
Italy
Romania
Ukraine  
Sites of Study
Modification(s)  
No of Sites = 7  
Name of Principal Investigator  Name of Site  Site Address  Phone/Fax/Email 
Dr Prasanna Kumar   Bangalore Diabetes Hospital  Bangalore Diabetes Hospital No 16/M Thimmaiah Road Miller Tank Bed Area Vasanth Nagar Bangalore Karnataka
Bangalore
KARNATAKA 		 919845156811
918022372980
trialsclinical@gmail.com 
DrDeshpande Neeta   Belgaum Diabetes Center  Belgaum Diabetes Center 2nd Floor, Maruti Galli,
Belgaum
KARNATAKA 		 919880271313
918314215380
neetarohit@gamil.com 
Dr Lodha Sailesh   Department of Endocrinology,Fortis Escort Hospital  Fortis Escorts Hospital JLN Marg, Malviya Nagar, Jaipur Rajasthan India
Jaipur
RAJASTHAN 		 01414008151
01412547002
saileshlodha@rediffmail.com 
Dr Yajnik C S   Diabetes Unit,KEM Hospital Research Center  KEM Hospital Research Center Diabetes Unit 6th Floor Banoo Coyaji Bldg Sardar Moodliar Road Pune Maharashtra India 411011
Pune
MAHARASHTRA 		 919822847281
912066405737
csyajnik@hotmail.com 
Dr Balamurgan  Kovai Diabetes speciality centre and Hospital  Kovai Diabetes Speciality Centre and Hospital 15 Vivekananda Road Ram Nagar Coimbatore Tamil Nadu India Pin 641009
Coimbatore
TAMIL NADU 		 09842244881
04224377732
balamurugan_dr@hotmail.com 
Dr Mahesh Uma  M V Hospital for Diabetes and Resarch Centre  M.V. Hospital for Diabetes and Diabetes Research Centre 4 West Mada Church Street Royapuram Chennai Tamil Nadu India
Chennai
TAMIL NADU 		 9600086981
04425954913
mahesh.kandikattu@gmail.com 
Dr Bantwal Ganapathi   St Johns Medical Collge and Hospital  St Johns Medical College and Hospital Department of Endocrinology Koramangala Bangalore Karnataka India Pin 560034
Bangalore
KARNATAKA 		 919448067318

mallyaganpathi@rediffmail.com 
 
Details of Ethics Committee
Modification(s)  
No of Ethics Committees= 7  
Name of Committee  Approval Status 
Bangalore Diabetes Hospital Ethics Committee  Approved 
Clinicom Committee for Evaluation of Protocols for Clinical Research  Approved 
Ethics Committee, KEM Hospital Research Center  Approved 
Institutional Ethical Review Board  Approved 
Institutional Ethics Committee Fortis Escorts Hospital  Approved 
Institutional Ethics Committee of Kovai Diabetes Speciality Centre & Hospital   Approved 
M V Hospital for Diabetes & Diabetes Research Centre  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Approved/Obtained 
 
Health Condition / Problems Studied
Modification(s)  
Health Type  Condition 
Patients  Type 1 Diabetes Mellitus,  
 
Intervention / Comparator Agent
Modification(s)  
Type  Name  Details 
Comparator Agent  Actrapid  Doses will be individualized based on the requirements of the patients; Treatment will be given approximately for 6 months (Arm B). 
Intervention  Insugen N  Doses will be individualized based on the requirements of the patients; Treatment will be given approximately for 1 year (Arm a) or 6 months (Arm B). 
Intervention  Insugen R  Doses will be individualized based on the requirements of the patients; Treatment will be given approximately for 1 year (Arm a) or 6 months (Arm B). 
Comparator Agent  Insulatard  Doses will be individualized based on the requirements of the patients; Treatment will be given approximately for 6 months (Arm B). 
 
Inclusion Criteria
Modification(s)  
Age From  18.00 Year(s)
Age To  80.00 Year(s)
Gender  Both 
Details  1. Provide written informed consent
2. Patients between the ages of 18 to 80 years
3. T1DM patients diagnosed with in the last 1 year.
4. Patients on basal-bolus insulin therapy
5. Body mass index of 18.5 to 34.99 kg/m2
6. Stable weight
7. Glycosylated haemoglobin of less than or equal to 11.0 percentage
8. Ability and willingness to comply with the protocol 
 
ExclusionCriteria 
Details  1. History of hypersensitivity to any of the active or inactive ingredients of the test and/or reference products
2. Significant history of atopy or allergic drug reactions
3. Use of insulin pump therapy
4. Moderate insulin resistance
5. A clinically significant laboratory abnormality on the basis of which the Investigator advises against study inclusion
6. Clinically significant disease, except for well-controlled hypertension, hyperlipidaemia and thyroid disorders which as per the investigator makes the patient unsafe to be included in the study
7. Complications of abnormal glucose control and secondary complications of diabetes
8. An electrocardiogram abnormality considered clinically significant by the Investigator
9. History of drug or alcohol dependence or abuse within 6 months before Screening
10. Use of medications that can affect sugar control
11. Any electively planned surgery requiring hospitalization
12. Pregnancy, breastfeeding, or planned pregnancy during the study duration. Women of childbearing potential (any woman who is not surgically sterile or more than 2 years post menopause) must agree to use a reliable method of contraception (e.g., double-barrier, tubal ligation, or stable hormonal contraception) throughout the study period. Women who become pregnant during the study must be discontinued from the study and followed for pregnancy outcome
13. Hematological disorders
14. Receipt of another investigational drug within 6 weeks before Screening or within 5 half-lives of the drug, whichever is longer, or scheduled treatment of another investigational drug during the current study period 
 
Method of Generating Random Sequence
Modification(s)  		 Stratified block randomization 
Method of Concealment   Centralized 
Blinding/Masking   Open Label 
Primary Outcome
Modification(s)  
Outcome  TimePoints 
Change in immunogenicity between Insugen R plus Insugen N and Actrapid plus Insulatard groups  From baseline to Week 24 and 48 
 
Secondary Outcome
Modification(s)  
Outcome  TimePoints 
Safety parameters including Local and systemic reactions, hypoglycaemic events per 100 patients and other AE’s  Between baseline, week 24 and 48 
Diabetes Treatment Satisfaction Questionnaire  Between baseline and week 24 
Partial correlation between allergic reactions and insulin antibodies, HbA1c and insulin antibodies, insulin dose and insulin antibodies  Between baseline and week 24 
Efficacy parameters including HbA1c, FPG, 7-PCBG and insulin dose  Between baseline and week 24 
 
Target Sample Size
Modification(s)  		 Total Sample Size="286"
Sample Size from India="56" 
Final Enrollment numbers achieved (Total)= ""
Final Enrollment numbers achieved (India)="" 
Phase of Trial   Phase 3 
Date of First Enrollment (India)
Modification(s)  		 08/10/2010 
Date of Study Completion (India) Date Missing 
Date of First Enrollment (Global)  05/10/2010 
Date of Study Completion (Global) Date Missing 
Estimated Duration of Trial
Modification(s)  		 Years="2"
Months="0"
Days="0" 
Recruitment Status of Trial (Global)
Modification(s)  		 Completed 
Recruitment Status of Trial (India)  Completed 
Publication Details
Modification(s)  		 N/A 
Individual Participant Data (IPD) Sharing Statement

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

Brief Summary
Modification(s)  		 This Study is a A Randomized, Active Controlled, Parallel Group, Multi-Center, Two Stage, Open Label, Study Comparing Safety and Immunogenicity of Insugen® R and Insugen® N with Actrapid® and Insulatard® in Patients with Type 1 Diabetes Mellitus for approximately 48 weeks in 286 patients that is conducted in India (8 sites), Germany (2 sites), Hungary (7 sites), Italy (4 sites), Romania (9 Sites), Ukraine (8 Sites),56 patients will be enrolled in India, 230 patients from Ukraine & EU. Primary outcome is to compare the change in mean anti Insulin antibody binding percentage from Baseline to week 24 for comparitive phase and from baseline to week 48 for non - comparative phase . Secondary outcome is to compare the Safety, Immunogenicity & efficacy of Insugen R plus Insugen N versus EU sourced Actrapid plus Insulatard.INC research is the CRO to conduct the trial. Date of first Enrollment will be around July end/August 2010. The Status of the whole trial is: Not yet recruiting. 
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