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CTRI Number  CTRI/2021/07/035244 [Registered on: 29/07/2021] Trial Registered Prospectively
Last Modified On: 13/07/2022
Post Graduate Thesis  No 
Type of Trial  Interventional 
Type of Study   Drug 
Study Design  Other 
Public Title of Study   Single group, multicenter phase IV clinical trial conducted in type 2 diabetes mellitus participants who are uncontrolled on oral anti-hyperglycemic drugs 
Scientific Title of Study   Multicentre phase IV Single arm clinical trial to evaluate the safety and Efficacy of Gla-300 in insulin-naïve patients with Type 2 Diabetes uncontrolled on oral anti-hyperglycemic drugs  
Trial Acronym  SAFEGUARD 
Secondary IDs if Any  
Secondary ID  Identifier 
LPS16665 Version no.: FINAL dated 26Jun2020  Protocol Number 
U1111-1255-5143  UTN 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name   
Designation   
Affiliation   
Address 




 
Phone    
Fax    
Email    
 
Details of Contact Person
Scientific Query
Modification(s)  
Name  Dr Saket Thaker 
Designation  Senior Medical Advisor and Clinical Safety Lead 
Affiliation  Sanofi Healthcare India Private Limited 
Address  Sanofi House, CTS No.117-B, L&T Business Park Saki Vihar Road, Powai Mumbai

Mumbai
MAHARASHTRA
400072
India 
Phone    
Fax    
Email  Saket.Thaker@sanofi.com  
 
Details of Contact Person
Public Query
Modification(s)  
Name  Dr Vishal Patil 
Designation  Clinical Project Leader 
Affiliation  Sanofi Healthcare India Private Limited 
Address  Sanofi House, CTS No.117-B, L&T Business Park Saki Vihar Road, Powai

Mumbai
MAHARASHTRA
400072
India 
Phone    
Fax    
Email  Vishal.Patil@Sanofi.com  
 
Source of Monetary or Material Support  
Sanofi India Limited, Sanofi House, C.T.S No.117b, L& T Business park, Saki Vihar Road, Powai, Mumbai -400072  
 
Primary Sponsor  
Name  Sanofi India Limited 
Address  Sanofi House, C.T.S No.117b, L& T Business park, Saki Vihar Road, Powai, Mumbai -400072  
Type of Sponsor  Pharmaceutical industry-Global 
 
Details of Secondary Sponsor  
Name  Address 
NIL  NIL 
 
Countries of Recruitment     India  
Sites of Study  
No of Sites = 14  
Name of Principal Investigator  Name of Site  Site Address  Phone/Fax/Email 
Dr Bipin Kumar Sethi  Care Outpatient Centre  Mallesam Building Block, 1st Floor, Road No-01, Banjara Hills, Hyderabad-500034, Telangana, INDIA
Hyderabad
TELANGANA 		 04039310129

Sethibipin54@gmail.com 
Dr Parminder Singh  Dayanand Medical College and Hospital  Tagore Nagar Civil Lines Ludhiana Ludhiana Punjab - 141001 India
Ludhiana
PUNJAB 		 9811077536

pam.endo@gmail.com 
Dr Jugal Bihari Gupta  Eternal Heart Care Centre & Research Institute  3-A, Jagatpura Road, Near Jawahar Circle, Jaipur-302020
Jaipur
RAJASTHAN 		 1415174000

drjbgupta@gmail.com 
Dr Ajay Agrawal  Fortis Hospital   A Block,Shalimar Bag, Shalimar Bagh, Delhi, 110088, India
North West
DELHI 		 9953055198

endocrinologist39@yahoo.co.in 
Dr Kiran Pal Singh  Fotis Hospital Mohali  Sector 62, Phase VIII, Mohali 160062, Punjab
Chandigarh
CHANDIGARH 		 9815311711

Drkp1292@gmail.com 
Dr Chandni R  Government  Medical College Kozhikode  4th Floor, Golden Jubilee Annex Institute of Maternal and Child Health Kozhikode Kozhikode Kerala - 673008 India
Kozhikode
KERALA 		 9447202748

chandnisajeevan@gmail.com 
Dr Saurabh Agrawal  GSVM Medical College  Room No-125, 1st Floor, Swaroop Nagar, Kanpur-208002, Uttar Pradesh, India
Kanpur Nagar
UTTAR PRADESH 		 9415039582

dragarwalsaurabh@qmail.com 
Dr Balamurugan Ramanathan  Kovai Diabetes Speciality Center and Hospita  #15, Vivekananda Road, Ram Nagar, Coimbatore-641009, Tamil Nadu, India
Coimbatore
TAMIL NADU 		 4224377732

rbmkdsc@gmail.com 
Dr Sreenivasa Murthy L   Life Care Hospital and Research Centre  2748-2152, M.L.N Enclave, 16th E CrossRoad, 8th Main, D-Block Next to Corporation Bank, Sahakarnagar Bangalore, Bengaluru (Bangalore) Urban Karnataka - 560092, India
Bangalore
KARNATAKA 		 08023631055

drlsm@icrc.in 
DrMohan Viswanathan  Madras Diabetes Research Foundation  4, Conran Smith Road Gopalapuram, Chennai, Chennai, Tamil Nadu - 600086 India
Chennai
TAMIL NADU 		 0444390888

drmohans@diabetes.ind.in 
Dr Rakesh Sahay   Osmania Medical College  Department of Endocrinology, Afzalgunj, Hyderabad, Telangana 500012, India
Hyderabad
TELANGANA 		 9849597507

sahayrk@gmail.com 
Dr Anil Bhansali   Post Graduate Institute of Medical Education and Research  Room No. 6006, IEC Office, 6th Floor P N Chuttani Block Chandigarh Chandigarh Chandigarh - 160012 India
Chandigarh
CHANDIGARH 		 9478111956

anilbhansaliendocrine@gmail.com 
DrPravin Dinkar Supe  Supe Heart and Diabetes and Research Centre  Opp. Adhar Ashram, Gharpure Ghat, Near Rungtha High School, Ashok Stambh, Nashik-422002, Maharashtra, India
Nashik
MAHARASHTRA 		 02532232487

pravinsupe@ymail.com 
Dr Jain Sunil Kumar  TOTALL Diabetes Hormone Institute  BCM Health Island, PU4, Scheme 54, Near Bombay Hosptial, Behind Prestige Management Institute, Indore-452010 (Madhya Pradesh) India
Indore
MADHYA PRADESH 		 7312443344

sunilmjain@gmail.com 
 
Details of Ethics Committee
Modification(s)  
No of Ethics Committees= 14  
Name of Committee  Approval Status 
Care Hospital, Institutional Ethics Committee_Dr. Bipin Kumar Sethi  Approved 
Drug Trial Ethics Committee_Dr. Parminder Singh  Approved 
Ethics Committee of Diabetes Thyroid Hormone Research Institute_Dr. Jain Sunil Kumar  Approved 
Ethics Committee_Dr. Saurabh Aggarwal  Approved 
IEC of Madras Diabetes Research Foundation_Dr. Mohan Vishwanathan  Approved 
Institutional Ethics Committee Govt Medical College Kozhikode_Dr. Chandni R  Approved 
Institutional Ethics Committee of Kovai Diabetes Speciality Centre & Hospital_Dr. Balamurugan Ramanathan  Approved 
Institutional Ethics Committee_Dr. Ajay Aggarwal  Submittted/Under Review 
Institutional Ethics Committee_Dr. Anil Bhansali  Submittted/Under Review 
Institutional Ethics Committee_Dr. Jugal Bihari Gupta  Approved 
Institutional Ethics Committee_Dr. Kiran Pal Singh  Approved 
Institutional Ethics Committee_Dr. Rakesh Sahay  Approved 
Life Care Hospital Institutional Review Board_Dr. Sreenivasa Murthy L  Approved 
Supe Hospital Ethics Committee_Dr. Praveen Supe  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Approved/Obtained 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  (1) ICD-10 Condition: E11||Type 2 diabetes mellitus,  
 
Intervention / Comparator Agent  
Type  Name  Details 
Intervention  Insulin glargine 300 U/mL / Gla-300/ Toujeo  Dosage level(s)- Dose regimen: recommended starting dose of Gla-300 is 0.2U/kg body weight once daily s.c injection 
Intervention  Insulin glargine 300 U/mL / Gla-300/ Toujeo  Dose formulation- prefilled (disposable) pen 
Intervention  Insulin glargine 300 U/mL / Gla-300/ Toujeo  Route of administration- Subcutaneous (s.c) injection 
Intervention  Insulin glargine 300 U/mL / Gla-300/ Toujeo  Unit dose strength(s) - Each prefilled pen contains a total of 450 units of insulin glargine (1.5 mL of 300units/mL insulin glargine) solution 
Comparator Agent  Not Applicable  Not Applicable 
 
Inclusion Criteria  
Age From  18.00 Year(s)
Age To  55.00 Year(s)
Gender  Both 
Details  Participants are eligible to be included in the study only if all of the following criteria apply:
Age
I 01. Participant must be 18 years of age inclusive, at the time of signing the informed consent
Type of participant and disease characteristics
I 02. Participants with type 2 diabetes mellitus.
I 03. Participants who are insulin naïve on at least one oral antihyperglycemic drug (metformin, sulfonylurea, thiazolidinedione, DPP-4 inhibitor, SGLT-2 inhibitor, glinide, α-glucosidase inhibitor) with or without glucagon-like peptide 1 receptor agonists (GLP-1 RAs) for a minimum period of 6 months prior to screening. The background non-insulin antidiabetic drug should be administered at stable dose for at least 8 weeks prior to screening
Sex
I 04. Male or female
Female participants: A female participant is eligible to participate if she is not pregnant, not breastfeeding, and at least 1 of the following conditions applies:
Not a woman of childbearing potential (WOCBP).
OR
A WOCBP who agrees to follow the contraceptive guidance during the intervention period and for at least 1 week after the last dose of study intervention (i.e., until Week 27).
Informed Consent
I 05. Capable of giving signed informed consent as described in Appendix 1 of the protocol which includes compliance with the requirements and restrictions listed in the informed consent form (ICF) and in this protocol.
Other criteria
I 06. HbA1c between 7.5% (58 mmol/mol) and 10% (86 mmol/mol) inclusive, during screening.
I 07. Median of the last 3 consecutive fasting self-monitored blood glucose (SMBG)values prior to baseline, or at least 2 fasting SMBG values in the week prior to baseline >130 mg/dL. 
 
ExclusionCriteria 
Details  Participants are excluded from the study if any of the following criteria apply:
Medical conditions
E 01. Any clinically significant abnormality identified either in medical history or during screening evaluation (e.g., physical examination, laboratory tests, electrocardiogram, vital signs) or any AEs during screening period, which in judgment of the Investigator would preclude safe completion of the study or constrains efficacy assessment.
E 02. History of severe hypoglycemia requiring emergency room admission or hospitalization within 3 months prior to screening visit.
E 03. Proliferative retinopathy or maculopathy requiring treatment according to the Investigator
Prior/concomitant therapy
E 04. Treatment with any insulin including basal insulin, mixed insulin (premixes), rapid insulin, and fast-acting insulin analogues in the last 6 months before screening visit (use ≤10 days in relation to hospitalization or an acute illness is accepted).
E 05. Use of non-insulin anti-hyperglycemic drugs other than those listed in inclusion criteria.
E 06. Use of systemic glucocorticoids (excluding topical application or inhaled forms) for 2 weeks or more within 8 weeks prior to screening visit.
E 07. Likelihood to require treatment prohibited by the protocol during the study
Prior/concurrent clinical study experience
E 08. Exposure to any investigational drugs in the last 4 weeks or 5 half-lives, whichever is longer, prior to screening visit or concomitant enrollment in any other clinical study involving an investigational study treatment.
Other exclusions
E 09. Any specific situation during study implementation/course that may raise ethics considerations.
E 10. History of hypoglycemia unawareness.
E 11. Hypersensitive to insulin glargine or any of the excipients
E 12. History of drug or alcohol abuse within 6 months prior to screening visit.
Additional criteria at the end of the screening period
E 13. Participants unwilling or unable to comply with study procedures as outlined in the protocol
E 14. Participants who withdraw consent during the screening (starting from signed ICF). 
 
Method of Generating Random Sequence   Not Applicable 
Method of Concealment   Not Applicable 
Blinding/Masking   Open Label 
Primary Outcome  
Outcome  TimePoints 
Objective:
To evaluate the safety of Gla-300 in insulin naïve T2D participants uncontrolled on oral antihyperglycemic Drugs
End point:
Percentage of participants with Treatment Emergent Adverse Events (TEAEs) including serious adverse events (SAEs) and hypoglycemic episodes
 		 week 24 
 
Secondary Outcome  
Outcome  TimePoints 
Objective:
To assess the efficacy of Gla-300 on glycemic control in insulin naïve T2D participants uncontrolled on oral anti-hyperglycemic drugs
To assess change in participant’s treatment satisfaction using DTSQs (Diabetes Treatment Satisfaction Questionnaire)
 		 Week 24 
End point:
Percentage of participants with at least 1 confirmed (Level 1) hypoglycemia event from baseline to Week 24.
Change in HbA1c from baseline to Week 12 and 24 Percentage of participants reaching general HbA1c target of 7% at Weeks 12 and 24.
Percentage of participants reaching targeted fasting selfmonitored blood glucose (SMBG) of 80 to 110 mg/dL (4.4 to 6.1 mmol/L) at Weeks 12 and 24
Change in fasting plasma glucose (FPG) from baseline to Week 24. 		 Week 24 
 
Target Sample Size   Total Sample Size="222"
Sample Size from India="222" 
Final Enrollment numbers achieved (Total)= "0"
Final Enrollment numbers achieved (India)="0" 
Phase of Trial   Phase 4 
Date of First Enrollment (India)   16/08/2021 
Date of Study Completion (India) Date Missing 
Date of First Enrollment (Global)  Date Missing 
Date of Study Completion (Global) Date Missing 
Estimated Duration of Trial   Years="3"
Months="8"
Days="0" 
Recruitment Status of Trial (Global)
Modification(s)  		 Not Applicable 
Recruitment Status of Trial (India)  Completed 
Publication Details   NIL 
Individual Participant Data (IPD) Sharing Statement

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

Response - NO
Brief Summary   This study is being done to meet the regulatory requirements of conducting a Phase 4 clinical trial for Gla-300 with more than 200 Indian participants. This India-specific study will evaluate the safety and efficacy of insulin glargine 300 U/mL in insulin naïve participants with T2D.
At present, the most widely used basal insulin is insulin glargine 100 U/ml (Gla-100), which has a well-established mode of action, and efficacy and safety profile. However, to improve current treatment options, a basal insulin conferring an even lower risk of hypoglycemia would be desirable.
New insulin glargine 300 U/ml (Gla-300) has been developed to optimize glycemic control, while minimizing the risk of hypoglycemia. After subcutaneous (s.c.) injection, the pharmacokinetic and pharmacodynamic action profiles of Gla-300 were more constant and prolonged compared with those of Gla-100, as a result of a more gradual and extended release of glargine from the s.c. depot. This translates into continued blood glucose control beyond 24 h.  
 
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