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CTRI Number  CTRI/2019/02/017636 [Registered on: 13/02/2019] Trial Registered Prospectively
Last Modified On: 12/02/2019
Post Graduate Thesis  No 
Type of Trial  Observational 
Type of Study   multicentre, multinational, prospective, single-arm, observational study 
Study Design  Other 
Public Title of Study   Observational study of Insulin Glargine 300 u/ml performed before, during and after period of Ramadan, in patients with Type 2 Diabetes Mellitus 
Scientific Title of Study   A multicenter, multinational, prospective, observational study to describe the clinical outcomes in patients with type 2 diabetes mellitus, treated with insulin glargine 300 U/mL (insulin glargine U300 before, during and after the period of Ramadan 
Trial Acronym  ORION 
Secondary IDs if Any  
Secondary ID  Identifier 
OBS 16040 Version 1.0 dated 25 Oct 2018  Protocol Number 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name   
Designation   
Affiliation   
Address 




 
Phone    
Fax    
Email    
 
Details of Contact Person
Scientific Query  
Name  DrGodhuli Chatterjee 
Designation  Senior Medical Advisor 
Affiliation  Sanofi India Limited 
Address  Sanofi India Limited Sanofi House, CTS No. 117-B, L&T Business Park, Saki Vihar Road, Powai, Mumbai – 400072

Mumbai
MAHARASHTRA
400072
India 
Phone  912228032822  
Fax  912228032842  
Email  Godhuli.Chatterjee@sanofi.com  
 
Details of Contact Person
Public Query  
Name  Ashish Virkar 
Designation  Clinical Project Leader 
Affiliation  Sanofi India Limited 
Address  Sanofi India Limited Sanofi House, CTS No.117-B, L&T Business Park Saki Vihar Road, Powai, Mumbai, Maharashtra 400072

Mumbai
MAHARASHTRA
400072
India 
Phone  912228032144  
Fax  912228032842  
Email  ashish.virkar@sanofi.com  
 
Source of Monetary or Material Support  
Sanofi India Limited Sanofi House, CTS No.117-B, L&T Business Park Saki Vihar Road, Powai, Mumbai, Maharashtra 400072 
 
Primary Sponsor  
Name  Sanofi India Limited 
Address  Sanofi House, CTS No.117-B, L&T Business Park Saki Vihar Road, Powai, Mumbai, Maharashtra 400072 
Type of Sponsor  Pharmaceutical industry-Global 
 
Details of Secondary Sponsor  
Name  Address 
NIL  NIL 
 
Countries of Recruitment     Canada
Egypt
Indonesia
Iran (Islamic Republic of)
Jordan
Kuwait
Lebanon
Pakistan
Qatar
Saudi Arabia
Turkey
United Arab Emirates
India  
Sites of Study  
No of Sites = 10  
Name of Principal Investigator  Name of Site  Site Address  Phone/Fax/Email 
Dr Ravi K Muppidi  AED hospital  Door no 301 & 302 Ground Floor,Challa estates, KPHB Phase 1, Road No3, Kukatpally, Hyderabad,Telangana 500072
Hyderabad
TELANGANA 		 9885554414

ravimuppidi@gmail.com 
Dr Rishi Shukla  Center For Diabetes And Endocrine Disease  113/14 B, Shahi Darbar Apartment, Swaroop Nagar, Kanpur - UP - 208002
Kanpur Nagar
UTTAR PRADESH 		 9415042286

drrishishukla@gmail.com 
Dr Vinod Mittal  Delhi Diabetes Care Centre  5/11791, Sat Nager , Karol Bagh , Delhi-110005
Central
DELHI 		 9810956373

drvinodmittal@gmail.com 
Dr Deepak Khandelwal  Dr. Khandelwals Endocrinology Clinic  Khandelwal Diabetes, Thyroid & Endocrinology Clinic, GH-1/1 Archana Apartment, Paschim Vihar, New Delhi-110063
West
DELHI 		 9968878561

khandelwalaiims@gmail.com 
Dr KirtikumarDharmshibaiModi  Dr. Modis Clinic  10-2-503, Royal Castle Building Beside Siddiqua Function Hall, Asifnagar Road, Mehdipatnam, Hyderabad Telangana 500028
Hyderabad
TELANGANA 		 9848115322

drkdmodi@yahoo.co.in 
Dr Mohammed Riyaz   Esani Diabetes and Multispeciality Centre  Plot no.8-1-21/41, Surya Nagar Colony, Towlichowki, Hyderabad-500008
Hyderabad
TELANGANA 		 9849132856

riyazesani@hotmail.com 
Dr Farishta Faraz  F S Endocrine Centre  Clinical Research Room number 02, Ground floor, Opp IOC petrol pump, Santosh Nagar, Hyderabad, 500059
Hyderabad
TELANGANA 		 9885035977

drfarazfarishta@gmail.com 
Dr Shobha Devi  Lifespan Diabetes and Metabolic Clinics  Plot no.185, 2nd Floor, Sai Jyothi Eye institute, Road No.1 West Mareddpally, Secunderabad, Hyderabad-500026
Hyderabad
TELANGANA 		 9866082624

hyddiabetes@gmail.com 
Dr Shanehyder A Zaidi  Sakshi Diabetic & Medical Centre  Flat No. 102, First, Satya Villa, Opposite High Court, Fate No.6,Ghansi Bazar, Hyderabad-500002
Hyderabad
TELANGANA 		 8897750902

dr_zaidi455@yahoo.com 
Dr Sadasiva Rao Yalamanchi  Yalamanchi Diabetes Specialities Center  Door Number 29-7-44; 1st Floor, Yalamanchi Hospitals and Research Centres Pvt. Ltd Venkataratnam Street, Dornakkal Road, Suryaraopeta, Governorpet, Vijayawada, Andhra Pradesh 520002
Krishna
ANDHRA PRADESH 		 9848132230

drsada@yahoo.com 
 
Details of Ethics Committee  
No of Ethics Committees= 10  
Name of Committee  Approval Status 
Institutional Ethics Committee, Yalamanchi Diabetic Specialities Centre  Submittted/Under Review 
Jehangir Clinical Development Centre Pvt Ltd., Pune- Dr. Modis Clinic  Approved 
Jehangir Clinical Development Centre Pvt Ltd., Pune- AED Hospital  Submittted/Under Review 
Jehangir Clinical Development Centre Pvt Ltd., Pune- Center For Diabetes And Endocrine Disease  Submittted/Under Review 
Jehangir Clinical Development Centre Pvt Ltd., Pune- Delhi Diabetes Care Centre  Submittted/Under Review 
Jehangir Clinical Development Centre Pvt Ltd., Pune- Dr. Khandelwals Endocrinology Clinic  Approved 
Jehangir Clinical Development Centre Pvt Ltd., Pune- Esani Diabetes and Multispeciality Centre  Approved 
Jehangir Clinical Development Centre Pvt Ltd., Pune- F S Endocrine Centre  Submittted/Under Review 
Jehangir Clinical Development Centre Pvt Ltd., Pune-Lifespan Diabetes and Metabolic Clinics  Submittted/Under Review 
Jehangir Clinical Development Centre Pvt Ltd., Pune-Sakshi Diabetic & Medical Centre  Submittted/Under Review 
 
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 
Intervention  NA  Observational Trial – Product Registry 
 
Inclusion Criteria  
Age From  18.00 Year(s)
Age To  99.00 Year(s)
Gender  Both 
Details  - Patient with T2DM treated with insulin glargine U300, as basal insulin for at least 8 weeks prior to inclusion in the study, and who plans to continue to be on insulin glargine U300, during the period of Ramadan.
- Patient who intends to fast for at least 15 days during Ramadan.
- Patient willing to sign written informed consent.
- Patient able and willing to perform SMPG according to physician instruction.
- Patient willing to complete study patient diary (for SMPG, insulin dose, and hypoglycemia) according to physician’s recommendation. 
 
ExclusionCriteria 
Details  - Age <18 years old or - Pregnant or Breastfeeding women.
- Diabetes other than T2DM.
- Treatment with basal bolus or premix regimen, in the 6 months prior to start of treatment with insulin glargine U300.
- Use of any investigational drug within 1 month or 5 half-lives, whichever is longer, prior to selection visit.
- Known hypersensitivity/intolerance to insulin glargine U300 or any of its excipients.
 
 
Method of Generating Random Sequence   Not Applicable 
Method of Concealment   Not Applicable 
Blinding/Masking   Not Applicable 
Primary Outcome  
Outcome  TimePoints 
To assess the percentage of patients experiencing at least 1 episode of severe and/or symptomatic documented hypoglycemia with plasma glucose (PG) ≤70 mg/dL (3.9 mmol/L) during the Pre-Ramadan, Ramadan, and Post-Ramadan periods.  5 months including one month of fasting in Ramadan 
 
Secondary Outcome  
Outcome  TimePoints 
To assess the incidence (percentage of patients with event) and event rate (frequency of occurrence) of symptomatic hypoglycemic episodes during the Pre-Ramadan, Ramadan, and Post-Ramadan periods.
To describe glycemic control parameters.
To describe overall safety and tolerability of the treatment throughout the study 		 5 months including one month of fasting in Ramadan 
 
Target Sample Size   Total Sample Size="516"
Sample Size from India="60" 
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   N/A 
Date of First Enrollment (India)   18/02/2019 
Date of Study Completion (India) Applicable only for Completed/Terminated trials 
Date of First Enrollment (Global)  05/02/2019 
Date of Study Completion (Global) Applicable only for Completed/Terminated trials 
Estimated Duration of Trial   Years="0"
Months="8"
Days="0" 
Recruitment Status of Trial (Global)   Open to Recruitment 
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   A multicenter, multinational, prospective, observational study to describe the clinical outcomes in patients with type 2 diabetes mellitus, treated with insulin glargine 300 U/mL (insulin glargine U300) before, during and after the period of Ramadan. A  patient‘s diary will be provided to the patients in order to collect their SMPG  values, as recommended by the physician, insulin doses and to report any episode of symptomatic hypoglycemia  and other health problems, information on days without fasting 
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