Clinical Trial Details (PDF Generation Date :- Wed, 25 Jul 2018 16:16:54 GMT) CTRI Number Last Modified On 16/05/2018 Post Graduate Thesis Type of Trial Type of Study Study Design Public Title of Study Scientific Title of Study CTRI/2018/05/013922 [Registered on: 16/05/2018] - Trial Registered Prospectively Observational Cross Sectional Study Other A study to describe control of glucose in blood and quality of life for type 1 diabetic adult patients Multinational, cross sectional, observational study to describe glycemic control and quality of life for type 1 diabetic adult patients Secondary IDs if Any Secondary ID Identifier Details of Principal Investigator or overall Trial Coordinator (multi-center study) Details Contact Person (Scientific Query) Details Contact Person (Public Query) OBS15151 version 1, 28 Jun 18 Designation Affiliation Protocol Number Details of Principal Investigator Dr Banshi Saboo Principal Investigator Dia Care Phone 9824047676 Fax Email Designation Affiliation Gandhi Park, 1, Near Nehrunagar Cross Road, 120 Feet Ring Rd, Vraj Vihar 2, Ambawadi Ahmadabad GUJARAT 380015 banshisaboo@hotmail.com Details Contact Person (Scientific Query) Dr Godhuli Chatterjee Senior Medical Advisor and Clinical safety Officer Sanofi Ltd Phone 2228032822 Fax 2228032842 Email Designation Affiliation Sanofi House CTS 117 B L and T Business Park Saki Vihar Road Powai Mumbai Mumbai 400072 Godhuli.Chatterjee@sanofi.com Details Contact Person (Public Query) Ekata Shah Clinical Project Leader Sanofi Ltd Phone 2228032175 Sanofi House CTS 117 B L and T Business Park Saki Vihar Road Powai Mumbai Mumbai 400072 page 1 / 6
Source of Monetary or Material Support Primary Sponsor Details of Secondary Sponsor Countries of Recruitment Sites of Study Fax 2228032842 Email ekata.shah@sanofi.com Source of Monetary or Material Support > Sanofi Synthelabo Private Limited Sanofi House, CTS 117 B, L and T Business Park Saki Vihar Road, Powai Mumbai 400072 Type of Sponsor NA List of Countries Algeria Argentina Brazil Bulgaria Chile Colombia Croatia France Germany Iran (Islamic Republic of) Italy Japan Saudi Arabia Serbia Thailand Ukraine United Kingdom of Principal Investigator Dr Neeta Deshpande Dr Shailesh Pitale Primary Sponsor Details Sanofi Synthelabo Private Limited Sanofi House, CTS.117 B, L and T Business Park Saki Vihar Road, Powai Mumbai 400072 Pharmaceutical industry-global NA of Site Site Phone/Fax/Email Belgaum diabetes Dew Medicare and Trinity Hospital 1575, Ground Floor, Maruthi Galli, Belgaum, Karnataka 590001 Belgaum KARNATAKA PLot 80, 81, Wardha Road, Hindustan Colony, Nagpur, Maharashtra 440015 Nagpur Dr Banshi Saboo Dia Care Gandhi Park, 1, Near Nehrunagar Cross Road, 120 Feet Ring Rd, Vraj Vihar 2, Ambawadi, Ahmedabad, Gujarat 9880271313 neetarohit@gmail.com 9822225631 drpitale@yahoo.co.in 9824047676 banshisaboo@hotmail.c om page 2 / 6
Details of Ethics Committee Dr Sharad Pendsey Dr Sailesh Lodha Dr Surendra Sharma Dr C S Yajnik Dr Anuj Maheshwari Dr Sunil Jain Dr Sadasiva Rao Diabetes Clinic And Research Center 380015 Ahmadabad GUJARAT W Park Rd, Congress Nagar, Dhantoli, Nagpur, Maharashtra 440012 Nagpur Dr Sailesh Lodha Clinic 759, Mahavir Nagar Ist Gopalpura Crossing, Tonk Road, Landmark: near gopalpura flyover, Jaipur - 30201 Jaipur RAJASTHAN Galaxy Speciality King Edward Medical Hospital Sri Hari Kamal Diabetes Clinic and Research Center Totall Diabetes and Research Yalamanchi Diabetic Specialities A 1, Madarmpura Ajmer Road, Sodala, Jaipur 302006 Jaipur RAJASTHAN 6th floor, Banoo Coyaji Bldg, Sardar Moodliar Road, Rasta Peth, Pune, Maharashtra 411011 Pune 9823078398 sharadpendsey2015@g mail.com 9829019055 saileshlodha@rediffmail.com 9829010233 sksharma7@gmail.com 9822847481 csyajnik@hotmail.com Jeevan Sahara Tower, 9839133984 Kursi Road, Landmark Near Gulachin Mandir, dranujm@gmail.com Lucknow, Uttar Pradesh 226022 Lucknow UTTAR PRADESH PU 4 Scheme. 54, Near Bombay Hospital, Behind Prestige Management Institute, Indore, Madhya Pradesh 452010 Indore MADHYA PRADESH 29 7 44, Venkataratnam street, Suryaraopet, Next To Dornakkal Road,Vijayawada 520002 Krishna ANDHRA PRADESH 7312443344 sunilmjain@gmail.com 9848132230 drsasiva@yahoo.com of Committee Approval Status Date of Approval Is Independent Ethics Committee? Institutional Ethics Committee, King Edward Medical Hospital Institutional Ethics Committee, Total Date Specified Date Specified page 3 / 6
Regulatory Clearance Status from DCGI Health Condition / Problems Studied Intervention / Comparator Agent Inclusion Criteria Diabetes and Research Institutional Ethics Committee, Yalamanchi Diabetic Specialities Status t Applicable Health Type Patients Date Specified Approved 11/05/2018 Approved 26/04/2018 Approved 11/05/2018 Date Specified Date Specified Date Specified Date Specified Date Date Specified Condition Type 1 Diabetes Mellitus Type Details Intervention NA NA Comparator Agent NA NA Age From Age To Gender Details 26.00 Year(s) 65.00 Year(s) Both 1 Male or female. Inclusion Criteria 2 Age greater than or equal to 26 years old. 3 Clinical diagnosis of presumed autoimmune T1DM treated by insulin. 4 Diagnosis of T1DM greater oe equal to 1 year. 5 Glycated hemoglobin value available within 30 days preceding the study visit or planned to be obtained in routine practice within 7 days after the study visit. 7 Signed written informed consent. Exclusion Criteria Details Exclusion Criteria 1 Diabetes other than type 1 diabetes eg, type-2 diabetes, secondary diabetes mellitus pancreatic history, drug or chemical-induced diabetes, genetic defects in beta cell function or insulin action. page 4 / 6
2 Patients unable to understand the nature and scope of the study, unable to read and write or unlikely to comply with the protocol, eg, inability and unwillingness to complete the PRO questionnaires. 3 Change from pump regimen to multiple insulin injections regimen, or switch from multiple dose injections to pump regimen within the last 3 months preceding study visit. 4 Treatment with oral antidiabetic drugs thiazolidinedione, sulfonylurea, dipeptidyl peptidase 4 inhibitors at any time from the diagnosis of T1DM. 5 Treatment with any investigational drug within the last 3 months Method of Generating Random Sequence Method of Concealment Blinding/Masking t Applicable Other t Applicable Primary Outcome Outcome Timepoints To describe the glycemic control in terms of the percentage of patients with T1DM who are at general target of HbA1c less than 7 percent in predefined age groups of 26 to 44 years, 45 to 64 years,less than 65 years old This is a cross sectional study and hence the analysis of the outcome would be of the same day as the enrollment date of patient Secondary Outcome Outcome Timepoints To evaluate in T1DM adult patients, in the predefined age groups 1 Psychosocial or PRO a Hypoglycemia fear. b Emotional status. c Treatment satisfaction. d Health related quality of life. 2 Clinical a Glycated hemoglobin levels, fasting plasma glucose FPG, and postprandial plasma glucose PPG. b Percentage of patients who are at individualized target HbA1c levels, as established by the physician. 3 Technology usage This is a cross sectional study and hence the analysis of the outcome would be of the same day as the enrollment date of patient Target Sample Size Phase of Trial Date of First Enrollment () Date of First Enrollment (Global) Estimated Duration of Trial Total Sample Size=4122 Sample Size from =200 N/A 21/05/2018 22/01/2018 Years=1 Months=0 page 5 / 6
Powered by TCPDF (www.tcpdf.org) PDF of Trial Recruitment Status of Trial (Global) Recruitment Status of Trial () Publication Details Brief Summary Days=0 Open to Recruitment t Yet Recruiting ne Yet Multinational, multicenter, single visit, non-interventional, cross-sectional, observational study. At the single study visit V1 and after signing the informed consent, eligible patients will be included. The Investigator will collect data from the patient s file and the patient s interview in an electronic case report form ecrf. Patients will report the outcomes in the respective PRO questionnaires. Assessments of HbA1c will be measured locally in routine practice using standard method at the laboratory of the respective site. investigations for the purpose of the study will be performed. page 6 / 6