FULL DETAILS (Read-only)  -> Click Here to Create PDF for Current Dataset of Trial
CTRI Number  CTRI/2022/09/045216 [Registered on: 05/09/2022] Trial Registered Prospectively
Last Modified On: 21/07/2025
Post Graduate Thesis  No 
Type of Trial  Observational 
Type of Study   Cross Sectional Study 
Study Design  Other 
Public Title of Study   Patients with Type 2 Diabetes Mellitus by using Glycemic Happiness  
Scientific Title of Study   A prospective, Multicentric, cross-sectional study to evaluate the psychosocial status of patients with Type 2 Diabetes Mellitus and treating physician using Glycemic Happiness (GH) scale 
Trial Acronym   
Secondary IDs if Any  
Secondary ID  Identifier 
DRL-IND-GGI18-GHDM/2022/Version No:1.0/Dated:04 May 2022  Protocol Number 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  Dr Devesh Kumar  
Designation  Director Clinical Trail Operations  
Affiliation  IR Innovate Research Pvt. Ltd 
Address  3rd Floor, C-120, C Block, Sector 2, Noida, Uttar Pradesh

Gautam Buddha Nagar
UTTAR PRADESH
201301
India 
Phone  7827758840  
Fax    
Email  devesh.kumar@innovate-research.com  
 
Details of Contact Person
Scientific Query  
Name  Dr Devesh Kumar  
Designation  Director Clinical Trail Operations  
Affiliation  IR Innovate Research Pvt. Ltd 
Address  3rd Floor, C-120, C Block, Sector 2, Noida, Uttar Pradesh

Gautam Buddha Nagar
UTTAR PRADESH
201301
India 
Phone  7827758840  
Fax    
Email  devesh.kumar@innovate-research.com  
 
Details of Contact Person
Public Query  
Name  Dr Devesh Kumar  
Designation  Director Clinical Trail Operations  
Affiliation  IR Innovate Research Pvt. Ltd 
Address  3rd Floor, C-120, C Block, Sector 2, Noida, Uttar Pradesh

Gautam Buddha Nagar
UTTAR PRADESH
201301
India 
Phone  7827758840  
Fax    
Email  devesh.kumar@innovate-research.com  
 
Source of Monetary or Material Support  
Dr. Reddys Laboratories Ltd. 7-1-27, Ameerpet, Hyderabad – 500016  
 
Primary Sponsor  
Name  Dr Reddys Laboratories Ltd 
Address  7-1-27, Ameerpet, Hyderabad – 500016 
Type of Sponsor  Pharmaceutical industry-Indian 
 
Details of Secondary Sponsor  
Name  Address 
NIL  NIL 
 
Countries of Recruitment     India  
Sites of Study
Modification(s)  
No of Sites = 30  
Name of Principal Investigator  Name of Site  Site Address  Phone/Fax/Email 
Dr Debmalya Sanyal  Ananda Clinic   Clinical Research Department 568, Diamond Harbour Road ,Auddy Bagan Basti , Behala Kolkata 700034.
Kolkata
WEST BENGAL 		 9830118388

drdebmalyasanyal@hotmail.com 
Dr Balaji Jaganmohan  Apollo Sugar Clinic  1st Floor, Padmanabha Nagar, 24, 18th Main Rd, , Bangalore, Karnataka 560070
Bangalore
KARNATAKA 		 9916756906

balajii81@gmail.com 
Dr Arthur Joseph Asirvatham  Arthur Asirvatham Hospital  Clinical Research Wing, 42-A Kuruvikaran Salai, Anna Bus stand, Madurai- 625020
Madurai
TAMIL NADU 		 9443751977

DRAJASIRVATHAM@YAHOO.CO.IN 
Dr Mala Dharmalingam  Bangalore Endocrinology & Diabetes Research Center & Laboratory.  Clinical Research Department,No.35,5th Cross, Malleshwaram , Bengaluru -560003
Bangalore
KARNATAKA 		 9845208163

mala_endo@rediffmail.com 
Dr Rufus Rajadurai  Bell Hospital  13/201-3, Tenkasi Main Road.Pavoorchatram-627808
Tirunelveli
TAMIL NADU 		 9894705708

dr.rufusrajadurai@yahoo.com 
Dr Ameya Joshi  Bhakti Vedanta Hospital and Research Institute   Department of Endocrinology, Shrishti Complex, Bhaktivedanta Swami Marg, Mira Road (East), Thane, 401107.
Thane
MAHARASHTRA 		 9820235675

ameyaable@gmail.com 
Dr Rishi Shukla  Center For Diabetes & Endocrine Diseases.  Clinical Research Department 113/14,Shahi Darbar Apartment , Swaroop Nagar, Kanpur 208002.
Kanpur Nagar
UTTAR PRADESH 		 9415042286

drrishishukla@gmail.com 
Dr K M Prasanna Kumar  Center for Diabetes and Endocrine Care   410/A,1st Stage, Clinical Research Department 3 Block, HBR Layout,Near BDA complex ,Kalyananagar Post, Bangalore-560043
Bangalore
KARNATAKA 		 9845156811

drkmpk@gmail.com 
Dr Hitesh puniyani  Chaitanya Cardio Diabetes Centre   B-331 Ramesh Nagar New Delhi. 110015
West
DELHI 		 9810836090

hiteshpunyani@yahoo.com 
Dr Vaishali Deshmukh  Deshmukh Clinic & Research Center.  Clinical Research Department 2nd Floor, Pinacle Prestige,1169 ,Sadashiv Peth Tilak Road Pune-411030
Pune
MAHARASHTRA 		 9850811450

dcrcpune@gmail.com 
Dr Vinay Dhandania  Diabetes Care Center   Bombay Chemist ,Sheetal Complex near Seva Sadan Hospital , Agrasen Path ,Ranchi-Jharkhand 834001
Ranchi
JHARKHAND 		 9431115394

vsudha72@yahoo.com 
Dr Kirti Samudra  Diabetes Care Clinic  Clinical Research Department Plot No-15, V.M.Marg, Sector-19,New Panvel, Opp Shreeyash Hospital, Navi Mumbai-410206
Raigarh
MAHARASHTRA 		 9867579565

dr.kirtisamudra@gmail.com 
Dr Jayashree Swain  Diabetic & Endocrine Clinic  Clinical Research Department ,Kalyani Nagar ,Infront of Sai Mandir, Cuttack 753013
Cuttack
ORISSA 		 9437271097

drjayshree_swain@yahoo.com 
Dr Rajiv Kovil  Dr Kovil Diabetes Care Centre  Clinical Research Department Zandra Health Care PVT LTD, Ground Floor D-17, Shiv Ashish, SV Road, Andheri West, Mumbai 400058
Mumbai
MAHARASHTRA 		 9820127777

drrajivkovil@hotmail.com 
Dr Shailaja Kale  Dr Shailaja Kales Diabetes & Specialty Clinics  Clinical Research Department 1212, Arun Apartment, Prabhat Road, Near Buldhana Urban Bank , Pune-411004
Pune
MAHARASHTRA 		 9822055458

drshailajakale24@gmail.com 
Dr Shreerang Godbole  Dr. Shreerang Godbole Clinic  Clinical Research Department 6,Poonam Arcade 1170/11 Revenue Colony,J.M.Road Shivajinagar Pune-411005
Pune
MAHARASHTRA 		 9890024412

instridepune@gmail.com 
Dr Abhay Kumar Sahoo  Institute of Medical Sciences and Sum Hospital  K-8 Kalinga Nagar, Ghatikia Bhubaneswar Odisha,lndia
Khordha
ORISSA 		 9438534785

drabhay76@gmail.com 
Dr Shehla Shaikh  K.G.N Diabetes & Endocrinology Centre.   Clinical Research Department 9/10 First Floor , Patel Arcades , Nagpada Junction ,Mumbai-400008
Mumbai
MAHARASHTRA 		 9820984842

drshehla@rediffmail.com 
Dr Saurav Dey  Kaberi clinic  33/3 Nisith Sen sarani Baidyapara Lane Baidyabati Hooghly, West Bengal is 712222
Hugli
WEST BENGAL 		 8697607461

talky.tum@gmail.com 
Dr Sunita Kadam  Kadam Diabetes Clinic  Dr.Lane Nanded, 431601, Maharashtra
Nanded
MAHARASHTRA 		 9860484144

sunitakadam@gmail.com 
Dr Deepak Khandelwal  Khandelwal Diabetes, Thyroid & Endocrinology Clinic  Archana Apartments,1,Pocket GH1, Paschim Vihar,Delhi,110063
West
DELHI 		 9968878561

khandelwalaiims@gmail.com 
Dr Sourav Das Chowdhury  Mediflora  117/A/1 Pilkhana Rd, Ranibagan, Berhampore, West Bengal 742101
Murshidabad
WEST BENGAL 		 8902708213

varuosdc@gmail.com 
Dr Girish Parmar  Nanavati Max Super Speciality Hospital  S.V, Road, Vile Parle(West) Mumbai -400056
Mumbai
MAHARASHTRA 		 9820718088

drgirish21@yahoo.co.in 
Dr Arundhati Dasgupta  Rudraksh Superspeciality Care   Clinical Research Department Malhotra Towers, Pradhan Nagar, Near Biswadeep Cinema Hall, Siliguri- 734001
Darjiling
WEST BENGAL 		 9674288225

drarundhatidg@gmail.com 
Dr Uday Phadke  Sahyadri Super Specialty Hospital  Clinical Research Department 30-C Karve Road, Erandwane Pune,411004.
Pune
MAHARASHTRA 		 9822025180

uday@drudayphadke.com 
Dr Priti J Sanghvi  Sanghavi’s Diabetes Clinic  501-B, Skyline Status, M.G.Road,Ghatkopar East Mumbai 400077
Mumbai
MAHARASHTRA 		 9820587337

drprity@gmail.com 
Dr Aarti Shahade  Shahade Hospital  Clinical Research Department 494/13,Parvati,Mitramandal Chowk,Pune-411009
Pune
MAHARASHTRA 		 9422322433

shahadehospital@yahoo.co.in 
Dr Santosh Shinde  Shinde Diabetes Centre  Dr. Lane Nanded, 431601 Maharashtra
Nanded
MAHARASHTRA 		 9970580699

drsantoshkshinde@gmail.com 
Dr Radha Rani P  Sri Sai Ram Endocrine & Diabetic Center   N.R.Peta 7th Line Kurnool 518004 Andhra Pradesh
Kurnool
ANDHRA PRADESH 		 9392377099

radharanipalanki@gmail.com 
Dr Vijaybhaskar Reddy  Vijay Diabetes, Thyroid and Endocrine Clinic  Clinical Research Department 12, First Cross Saradambal Nagar , Puducherry-605005
Pondicherry
PONDICHERRY 		 7598678215

svbreddy1976@gmail.com 
 
Details of Ethics Committee
Modification(s)  
No of Ethics Committees= 2  
Name of Committee  Approval Status 
Royal Pune Independent Ethics Committee  Approved 
Royal Pune Independent Ethics Committee  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  (1) ICD-10 Condition: E119||Type 2 diabetes mellitus without complications,  
 
Intervention / Comparator Agent  
Type  Name  Details 
 
Inclusion Criteria  
Age From  18.00 Year(s)
Age To  90.00 Year(s)
Gender  Both 
Details  1-Patients of either sex aged 18 years and above.
2-Willing and able to sign Data Disclosure consent form.
3-Patients with clinical diagnosis of Type 2 Diabetes Mellitus 
 
ExclusionCriteria 
Details  As this is cross-section study, exclusion criterias will not be applicable for this study. 
 
Method of Generating Random Sequence   Not Applicable 
Method of Concealment   Not Applicable 
Blinding/Masking   Not Applicable 
Primary Outcome  
Outcome  TimePoints 
To evaluate the psychosocial status of patients with Type 2 Diabetes Mellitus and treating physician using Glycemic Happiness (GH) scale  Day-1 (Visit -1) 
 
Secondary Outcome  
Outcome  TimePoints 
To corelate the baseline demographic, disease characteristics (age, gender, duration of diabetes, risk factors etc.) and current T2DM management status with psychosocial health of patients with T2DM using GH scale  Day-1 (Visit -1) 
 
Target Sample Size   Total Sample Size="400"
Sample Size from India="400" 
Final Enrollment numbers achieved (Total)= "0"
Final Enrollment numbers achieved (India)="0" 
Phase of Trial   N/A 
Date of First Enrollment (India)   05/09/2022 
Date of Study Completion (India) 13/09/2023 
Date of First Enrollment (Global)  Date Missing 
Date of Study Completion (Global) Date Missing 
Estimated Duration of Trial   Years="1"
Months="6"
Days="0" 
Recruitment Status of Trial (Global)
Modification(s)  		 Not Applicable 
Recruitment Status of Trial (India)  Completed 
Publication Details   Data Would Be Published Once Study Is Complete 
Individual Participant Data (IPD) Sharing Statement

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

Response - NO
Brief Summary  
This survey is a A prospective, Multicentric, cross-sectional study to evaluate the psychosocial status of patients with Type 2 Diabetes Mellitus and treating physician using Glycemic Happiness (GH) scale in India. Patients with clinical diagnosis of Type 2 Diabetes Mellitus will be invited to take part in the survey. All participants will sign an Informed Consent Form to get enrolled in the survey. Investigator will collect all required data from the participants and complete the Case record form with available information.



 
Close