CTRI

FULL DETAILS (Read-only) -> Click Here to Create PDF for Current Dataset of Trial

CTRI Number

CTRI/2018/09/015693 [Registered on: 11/09/2018] Trial Registered Prospectively

Last Modified On:

22/04/2019

Post Graduate Thesis

Type of Trial

Observational

Type of Study

drug

Study Design

Single Arm Study

Public Title of Study

Management of Type II diabetes mellitus in Indian population

Scientific Title of Study

Real world experience of Glycomet GP (Glimepiride/Metformin) in management of Type 2 Diabetes mellitus in Indian Setting (REAL GGP)

Trial Acronym

USV/REALGGP/01

Secondary IDs if Any

Secondary ID	Identifier
USV/REALGGP/01 V3.0, 05Jun 2018	Protocol Number

Details of Principal Investigator or overall Trial Coordinator (multi-center study)

Name	Manohar Koppala
Designation	trial coordinator
Affiliation	CRA Abiogenesis Clinpharm Private Limited
Address	Doctus building Road No 10 Banjara Hills Doctus building Road No 10 Banjara Hills Hyderabad ANDHRA PRADESH 500034 India
Phone	8008043326
Fax
Email	manoharkoppala@abiogenesisclinpharm.com

Details of Contact Person
Scientific Query

Name	Dr Mahesh Abhyankar
Designation	Vice President - Scientific affairs
Affiliation	USV Private Limited
Address	Arvind Vithal Gandhi Chowk BSD Marg, Govandi Mumbai Mumbai MAHARASHTRA 400088 India
Phone	912225564048
Fax	912225584025
Email	drmahesh.abhyankar@usv.in

Details of Contact Person
Public Query

Name	Pawan Bhusari
Designation	CEO
Affiliation	Abiogenesis Clinpharm Private Limited
Address	Doctus building Road No 10 Banjara Hills Hyderabad ANDHRA PRADESH 500034 India
Phone	914038117077
Fax	914038117078
Email	pawanbhusari@abiogenesisclinpharm.com

Source of Monetary or Material Support

USV private limited B.S.D Marg Arvind Vithal Gandhi Chowk Govandi East, Mumbai Maharashtra 400088

Primary Sponsor

Name	USV Private Limited
Address	USV Private Limited Arvind Vithal Gandhi Chowk BSD Marg Govandi Mumbai 400088, India
Type of Sponsor	Pharmaceutical industry-Indian

Details of Secondary Sponsor

Name	Address
NIL	NIL

Countries of Recruitment

India

Sites of Study

No of Sites = 50
Name of Principal Investigator	Name of Site	Site Address	Phone/Fax/Email
Dr Prabhurami Reddy	Aadhithya Poly clinic	Room No.101,Above TVS showroom,1st floor,Pillar No.136,Attapur,Hyderabad Hyderabad ANDHRA PRADESH	988550685 drprabhu6@gmail.com
Dr S Naganarsimhaiah	Athreya Specialist Centre	Room no.103,1st floor,B.G.R Complex,2nd Cross,MG Road,Tumkur-572101 Tumkur KARNATAKA	9845294823 naagsnaags@gmail.com
Dr Parmesh S	Bangalore Diabetes Centre	Room No.426,2nd Block,4th cross,2nd block, Kalyan nagar,Bangalore-560043 Bangalore KARNATAKA	9845010359 drparmesh2@gmail.com
Dr Bensley L Gonsalves	Bliss Diabetes Centre	111,Landmark towers,opp.Bisops house,West Vasai-401207 Mumbai (Suburban) MAHARASHTRA	7767822887 bensleyg@gmail.com
Dr Jagdish Mulchandani	Diabetes,Thyroid & Hormones Centre	1/29,Sundar Vihar,Outer ring road, New Delhi-110087 New Delhi DELHI	9810208782 jags149@gmail.com
Dr K Arun Karthik	Diacare Diabetes Specialities	Plot no.11/13,Raja Annamalai road,Saibaba Colony,Coimbatore-641011 Coimbatore TAMIL NADU	9894724752 drarunkarthik@yahoo.com
Dr Guruprasad Udupi	Dialife	Plot No.962,1st Floor,BEL Layout,Vidyanarayanpura Main road,Bangalore-560097 Bangalore KARNATAKA	9901681661 guruprasad6699@gmail.com
Dr Sudha N Sathiyan	Diet and Diabetic Centre	No.1307,Avinashi Road,Peelamed,Coimbatore-641004 Coimbatore TAMIL NADU	9944915791 drsudhasathian@gmail.com
Dr D Narayan Reddy	DNR Diabetes Center	19-8-9c HR colony,RC Road,Tirupati,Chittor Chittoor ANDHRA PRADESH	9440765815 dnrdiab@gmail.com
Dr Rajitha C	Dr Anils Diabetic Centre	D-R-2,MIG Plot No.77,DR Colony,Phase 11,Vasanth Nagar,Kukatpally Hyderabad-500085 Hyderabad ANDHRA PRADESH	988504447 rajitachichivi@gmail.com
Dr K Madhusudhan Reddy	Dr Madhu Diabetex clinic	first floor Plot no.1-21,Railway station Road,Rajampeta,Kadapa-516115 Cuddapah ANDHRA PRADESH	9989664663 madhukypa@gmail.com
Dr Sanjay Jain	Dr Sanjay Jain clinic	Plot No.156,Harsh Vihar,Pitampura,Delhi-110034 North West DELHI	9810048131 neelamjain@gmail.com
Dr TR Sivagnanam	Dr T R Sivaganam Clinic	H.No.51, D J Nagar, Peelamedu, Coimbatore, Tamil Nadu Coimbatore TAMIL NADU	04222627784 trsivagnanam@gmail.com
Dr D Govindappa	Dr.Govinds Medical & Diabetes Centre,	Room No.541,5th floor, 17th Main, 4th sector,HSR Layout,Bangalore-560034 Bangalore KARNATAKA	9343741675 govindappa.d@gmail.com
Dr RajMohan L	Dr.Mohans Diabetic Centre	TC No.3/1914-4/5, 2nd Floor, Daniels Tower, M.G. ROAD, Pattom Post,Thiruvananthapuram, Kerala 695004 Thiruvananthapuram KERALA	8714808542 dr_rajmohan@hotmail.com
Dr Sudhir Patnaik	Dr.Sudhir Patnaik Diabetc Clinic	H.No.4,Tulsi Vihar,Bhubaneshwar-751021 Khordha ORISSA	9437040797 drsudhir90@gmail.com
Dr Suresh Chandra Sahoo	Dr.Suresh chandra sahoo Diabetic clinic	Room no.3R,13th floor,Doctors Colony,Burla,Sambalpur-768017 Sambalpur ORISSA	9437257411 sureshsahooburla@gmail.com
Dr B Ravi Kumar	Ebdocare superspeciality hospital	Opp HPS school,JJ x roads,Khaleelwadi,Nizamabad-503001 Nizamabad ANDHRA PRADESH	7729808603 RAVIY2K@gmail.com
Dr Gajjela RamaKrishna Reddy	G.S.R Heart Care Centre	20/899,Co-operative Colony,Kadapa-516001 Cuddapah ANDHRA PRADESH	9848479399 gajjelarkr@gmail.com
Dr Rabindra Kumar Dash	Gupta diagnostics	Plot no.4,Road No.10,Lalbazaar chowk,Hospital road,Baripada,Mayurbhanj-757001 Mayurbhanj ORISSA	9437612115 rabi.dash76@gmail.com
Dr Balasubrahmanyam K	Hyderabad Diabetes Centre	Nig-241,Road No:4,KPHB Colony,Hyderabad-500072 Hyderabad ANDHRA PRADESH	04023157667 bskantamneni@gmail.com
Dr Bharat Panigrahy	Jaydurga Clinic	Room no.51/2,Jayadev Vihar,Patia Road,Bhubhneshwar-751024 Khordha ORISSA	9437060977 bharat.panigrahy@gmail.com
Dr KM Jeyabalaji	JB Clinic	80/1,Nehru colony,Mahalingapuram,Pollachi-642002 Coimbatore TAMIL NADU	9865322121 maildrbala@gmail.com
Dr Ajay Patwari	Jharkhand Diabetic and Eye Centre	Plot no.541/2,Ground floor,Diabetes division,Joraphatak Road,Near Shakti Mandir,Dhanbad-826001 Dhanbad JHARKHAND	9771907242 ajaypatwari@yahoo.com
Dr D Mathru	Padma Devi Clinic	Plot No#6-3-124,Sai Baba Temple Lane,VT Talkies Road,Ramagiri,Nalgonda-508001 Nalgonda ANDHRA PRADESH	9848658885 drmathru@yahoo.com
Dr Rajesh Gupta	Pentamed Hospital	K-17,Model town,Delhi-110009 North West DELHI	9811079647 rajeshgupta20@gmail.com
Dr C Pradeep	Pradeep Diabetes Centre	Door no.46-9-52By-pass Road,Danavaipeta,Rajahmundry-533103 East Godavari ANDHRA PRADESH	9441649955 pradeepdiab@hotmail.com
Dr Karunesh Kumar HS	Pristine Consultations and diagnostics	Flat No.50,8th Block,1st floor,KHB Colony,Opp to Post office,below SBM,Koramangala,8th block,Bangalore-560095 Bangalore KARNATAKA	9844050987 drkaruneshkumar@yahoo.co.in
Dr Gopal Agarwal	Pulse Mediclinic	Plot no.2603/1,Ground Floor,Bhatli Road,Bargarh-768028 Bargarh ORISSA	9437055211 dr_gopalagr@yahoo.com
Dr AM Rao	Raos diabetic care centre	Kamala Hospital Backside,Opp.Ideal degree College for wome,Dilsukhnagar,Hyderabad-500060 Hyderabad ANDHRA PRADESH	9491214647 amudele_mallikarjunrao@yahoo.com
Dr Manoj Kumar Dash	RV Centre for Diabetes	2-3,1st floor,skill spectrum,3-6-367,Himayat nagar,Hyderabad-500029 Hyderabad ANDHRA PRADESH	9849681485 manojdoc2004@yahoo.co.in
Dr G V Siva Reddy	S.P. Diabetes Centre	1/700-5,Dwaraka Nagar,Kadapa Cuddapah ANDHRA PRADESH	9849508762 drsivareddys@gmail.com
Dr Rakesh Kumar Sahay	Sahays Endocrine and Diabetes Centre	6-3-852/A,Ameerpet,Hyderabad-500016 Hyderabad ANDHRA PRADESH	9849597507 sahayrk@gmail.com
Dr Jagdish Singh	Sai diabetic clinic	7-1-215/14,Balkampet,Hyderabad-500016 Hyderabad ANDHRA PRADESH	984051904 drjagsgh@yahoo.co.in
Dr Umakanta Mishra	Sai Shree Medical Hall	Plot No.89/91,Canal road,Nuasahi,Rasulgarh,Bhubaneshwar-751010 Khordha ORISSA	9437308717 umakantamishra13@gmail.com
Dr M Leelavathi	Sai Vasundhara Hospital	Room No.3/1562,Ground Floor,Homaspeta, Proddatur,Kadapa-516360 Cuddapah ANDHRA PRADESH	8885444296 ramasubbareddymallela@yahoo.com
Dr Ramesh Kumar Goenka	Satayu Hospital & Diabetic Research Centre	Plot No.666/1,Lal Bahadur Sastri Colony,Old station bazaar,Bhubaneshwar Khordha ORISSA	9437001754 goenka2000@yahoo.co.uk
Dr P Sudhakar Reddy	secundrabad Diabetes and Hormone Clinic	Shivarama krishna college,west marredpally,Secundrabad-500003 Hyderabad ANDHRA PRADESH	9848449812 psreddy27@gmail.com
Dr Mohammed Idrees	Shahzad Diabetic Centre	Hno.9-4-51/13,Hakeempet,Towlichowki,Hyderabad Hyderabad ANDHRA PRADESH	9849547330 mohammedidrees@gmail.com
Dr Ch Naveen Kumar	Shanthi Diabetes Specialities	Plot no.21,Opp.ankura Hospital,Balaji Nagar,Khammam-507001 Khammam ANDHRA PRADESH	9440892130 drnaveenkmm@gmail.com
Dr Ritesh Kumar Agrawala	Shanti Pawan Superspeciality Hospital	Plot No.A/64-Shaheed Nagar,Bhubaneshwar-7 Khordha ORISSA	9861336985 drriteshagr@gmail.com
Dr MR Vidhya	Shri Lakshmi Nivas	No.18,5th cross west,Kurinji Nagar extn,Lawspet,Puducherry-605008 Pondicherry PONDICHERRY	9442159662 vassoudev@yahoo.co.in
Dr P Chandramohan	Sivam Diabetes Centre	Plot no.255-Brough road,Erode-638001 Erode TAMIL NADU	9842852530 cmsivam@gmail.com
Dr Vinayaswami PM	Sree Guru Basaweshwara Diabetic Care Centre	Room No.1671/6,6th floor,MCCB Block,Sree Guru Krupa Society, Vidyanagar,Davangere-577004 Davanagere KARNATAKA	9448051151 winsomi@yahoo.com
Dr K Rajesh	Sri Datta Multispeciality Hospital	Opp. to RDO Office,Saraswati nagar,Khaleelwadi,Nizamabad-503002 Nizamabad ANDHRA PRADESH	9290796942 raju669@yahoo.co.in
Dr G Rajagopal	Sri Rhi Endocare Clinic	Flat No.43/7A,Beside DVR Hotel,Opp. childrens park,NR peta,Kurnool-518001 Kurnool ANDHRA PRADESH	9440581147 drraj77@gmail.com
Dr Pratap Kumar Mishra	Sriram Pharma Shop	Plot no.444/1,Ground floor,RamMandir square,Bhubaneshwar-751001 Khordha ORISSA	9437148858 drpratap.mishra@gmail.com
Dr K Babuchakravorthy K	SS Heart & Skin care Hospital	Plot No.15/10,Sundara vinayagar koil street,Kallakuruchi-606202 Viluppuram TAMIL NADU	9442730666 dr.babuchakkaravarthy@gmail.com
Dr B Prasanna	Tilaknagar Hospital	Plot No.2-2-1108/1/A/2,Tilaknagar,Hyderbad-500044 Hyderabad ANDHRA PRADESH	8374079713 prasanna.belgunda@gmail.com
Dr Utkal Kishore Khadenga	Utkal Diabetes Care	N-1/258,CRP Square,IRc Village,Bhubaneshwar-15 Khordha ORISSA	9776115333 drutkalkishore@gmail.com

Details of Ethics Committee
Modification(s)

No of Ethics Committees= 1
Name of Committee	Approval Status
Clinicon Independent Ethics Committee for evaluation of protocols for clinical research	Approved

Regulatory Clearance Status from DCGI

Status

Not Applicable

Health Condition / Problems Studied

Health Type	Condition
Patients	(1) ICD-10 Condition: E08-E13\|\|Diabetes mellitus,

Intervention / Comparator Agent

Type	Name	Details
Comparator Agent	NIL	NIL

Inclusion Criteria

Age From	18.00 Year(s)
Age To	75.00 Year(s)
Gender	Both
Details	Both Male and Female patients of age 18 years or older Patients who have received any strength of Glycomet GP (Glimepiride/Metformin) for the treatment of type 2 diabetes mellitus Treating physician had to agree to provide information regarding the participants treatment Patients whose medical records contains a minimum core data set; core data defined as: age, gender, duration of diabetes/ age at diagnosis, all glucose-lowering medications (branded and generic names, dosage and dosing frequency).

ExclusionCriteria

Details

Patients with Type 1 diabetes mellitus
Patients with cancer, end stage liver disease, end stage renal failure (non-diabetes related)
Female patients with gestational diabetes during pregnancy

Method of Generating Random Sequence

Not Applicable

Method of Concealment

Not Applicable

Blinding/Masking

Open Label

Primary Outcome

Outcome	TimePoints
Percentage of patients in various age group receiving Glycomet GP (Glimepiride/Metformin) Number & percentage of Participants with Concomitant Conditions Number & percentage of Participants with Concomitant Therapies Duration of diabetes of participants received Glycomet GP (Glimepiride/Metformin) Dosage patterns of Glycomet GP (Glimepiride/Metformin) received by the participants	retrospective data

Secondary Outcome

Outcome	TimePoints
Nil	Nil

Target Sample Size

Total Sample Size="8500"
Sample Size from India="8500"
Final Enrollment numbers achieved (Total)= "Applicable only for Completed/Terminated trials"
Final Enrollment numbers achieved (India)="Applicable only for Completed/Terminated trials"

Phase of Trial

Post Marketing Surveillance

Date of First Enrollment (India)

12/09/2018

Date of Study Completion (India)

Applicable only for Completed/Terminated trials

Date of First Enrollment (Global)

Date Missing

Date of Study Completion (Global)

Applicable only for Completed/Terminated trials

Estimated Duration of Trial

Years="0"
Months="6"
Days="0"

Recruitment Status of Trial (Global)

Not Applicable

Recruitment Status of Trial (India)

Not Yet Recruiting

Publication Details

none yet

Individual Participant Data (IPD) Sharing Statement

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

Brief Summary

The objective of the study is to investigate real-world treatment patterns for use of Glycomet GP (Glimepiride/Metformin) and concomitant medications in Indian patients with type 2 diabetes mellitus treated within the primary care physicians and specialist care settings.

The real world experience study will be conducted in Indian health care centers having medical records of adult patients with type 2 diabetes mellitus who had received treatment with Glycomet GP (Glimepiride/Metformin) .

Data related to demographic characteristics, efficacy, and safety parameters will be collected from medical records authenticated by physicians during routine care.