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CTRI Number  CTRI/2018/05/013853 [Registered on: 14/05/2018] Trial Registered Prospectively
Last Modified On: 27/07/2022
Post Graduate Thesis  Yes 
Type of Trial  Interventional 
Type of Study   Drug 
Study Design  Other 
Public Title of Study   Efficacy and Safety of the Insulin Glargine or Lixisenatide Fixed Ratio Combination Versus Insulin Glargine in Patients With Type 2 Diabetes  
Scientific Title of Study   A randomized 24 week controlled open label parallel arm multicenter study comparing the efficacy and safety of the insulin glargine AND lixisenatide fixed ratio combination to insulin glargine in type 2 diabetes patients inadequately controlled on Basal Insulin with or without Metformin 
Trial Acronym  NA 
Secondary IDs if Any  
Secondary ID  Identifier 
INSLIL08556 version 1.1 dated 25 September 2017  Protocol Number 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
Modification(s)  
Name   
Designation   
Affiliation   
Address 




 
Phone    
Fax    
Email    
 
Details of Contact Person
Scientific Query  
Name  Dr Godhuli Chatterjee 
Designation  Senior Medical Advisor and Clinical Safety Officer 
Affiliation  Sanofi India Limited 
Address  Sanofi House CTS No 117 B L and T Business Park Saki Vihar Road Powai Mumbai

Mumbai
MAHARASHTRA
400072
India 
Phone  919930057699  
Fax    
Email  godhuli.chatterjee@sanofi.com  
 
Details of Contact Person
Public Query  
Name  Ajit Walekar 
Designation  Senior Clinical Project Leader 
Affiliation  Sanofi India Ltd 
Address  Sanofi House CTS No 117 B L and T Business Park Saki Vihar Road Powai Mumbai

Mumbai
MAHARASHTRA
400072
India 
Phone  912228032824  
Fax    
Email  ajit.walekar@sanofi.com  
 
Source of Monetary or Material Support  
Sanofi Synthelabo India Private Limited CTS No 117 B L and T Business Park Saki Vihar Road Powai Mumbai 400072 
 
Primary Sponsor  
Name  Sanofi Synthelabo India Private Limited 
Address  CTS No 117 B L and 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
Modification(s)  
No of Sites = 13  
Name of Principal Investigator  Name of Site  Site Address  Phone/Fax/Email 
Dr Rajesh Khadgawat  AIIMS Hospital  Ansari Nagar New Delhi 110029
South
DELHI 		 919891418190

rajeshkhadgawat@hotmail.com 
Dr Arthur Asirvatham  Arthur Asirvatham Hospital  Clinical Research Wing 42A Kuruvikaran Salai Ground Floor Anna Bus Stand Madurai 625020
Madurai
TAMIL NADU 		 919443751977
04522531977
ajasirvathamresearch@yahoo.in 
Dr Yogesh Kadam  CIMET’s Inamdar Multispecialty Hospital  Admin building, Research Department, Fatima Nagar, Pune-411040
Pune
MAHARASHTRA 		 9823141402

ydkresearch10@gmail.com 
Dr Faraz Farishta  Department of Clinical Research Max Cure Hospitals  1st Floor, Room No 115 5 9 22, Secretariat Road Hyderabad 500063

 		 919885035977

drfarazfarishta@gmail.com 
Dr Manish Gutch  Dr Ram Manohar Lohia Institute of Medical Sciences  Department of Endocrinology Lucknow, U P – 110001
Lucknow
UTTAR PRADESH 		 9453429252

manish07gutch@gmail.com 
Dr J B Gupta  Eternal Hospital  3A, Jagatpura Road, Near Jawahar Circle, Jaipur 302017
Jaipur
RAJASTHAN 		 9198294114680

drjbgupta@gmail.com 
Dr Binayak Sinha  Fortis Hospital  730 Anandpur Level 3 Clinical Research Cell E M Bypass Road Kolkata 700107
Kolkata
WEST BENGAL 		 919830096410

binayak.sinha@gmail.com 
Dr Vikrant Ghatnatti  KLEs Dr Prabhakar Kore Hospital and Medical Research Centre  Nehru Nagar Belgaum 590010 Karnataka India
Belgaum
KARNATAKA 		 919844445598

victorvikrant@gmail.com 
Dr Balamurugan   Kovai Diabetes Speciality Centre & Hospital  15 Vivekananda Road, Ramnagar, Coimbatore - 641009 Tamil Nadu
Coimbatore
TAMIL NADU 		 9842244881

balamurugan_dr@hotmail.com 
Dr L S Murthy  Lifecare Clinic & Research Centre  2748 oblique 2152 M L N Enclave 16th E Cross 8th Main D Block Next to Corporation Bank Sahakarnagar Bangalore 560092
Bangalore
KARNATAKA 		 919448051046

drlsm@lcrc.in 
Dr V Mohan   Madras Diabetic Research  No 4 Conran Smith Road Gopalapuram Chennai-600086 Tamil Nadu, India
Chennai
TAMIL NADU 		 4428350935
914428350935
drmohans@diabetes.ind.in 
Dr P V Rao  Ramdev Rao Hospital  2nd Floor Kumudini Devi Diabetes Research Center Kukatpally Hyderabad 500072

 		 919885051110

raopaturi@gmail.com 
Dr Pravin Supe  Supe Hospital  Gharpure Ghat Behind Rungtha High School In front of Adharashram Ashokstambh Nasik 422002
Nashik
MAHARASHTRA 		 919405366165

pravinsupe@ymail.com 
 
Details of Ethics Committee
Modification(s)  
No of Ethics Committees= 13  
Name of Committee  Approval Status 
Eternal Heart Care Centre and Research Institute Institutional Ethics Committee  Approved 
Ethics Committee KLE University_Dr. Vikrant Ghatnatti  Approved 
Ethics Committee_Dr. Yogesh Kadam   Approved 
Fortis Hospital Ethics Committee  Approved 
Institutional Ethics Committee Arthur Asirvatham Hospital  Approved 
Institutional Ethics Committee-Dr V Mohan  Approved 
Institutional Ethics Committee_Dr. Rajesh Khadgawat  Approved 
Institutional Ethics Committe_Dr. Manish Gutch   Approved 
Institutional Ethics Committe_Dr. R Balamurugan  Approved 
Life Care Hospital Institutional Review Board  Approved 
Maxcure Hospitals Institutional Ethics Committee  Approved 
Ramdevrao Hospital Institutional Ethics Committee  Approved 
Supe Hospital Ethics Committee  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Approved/Obtained 
 
Health Condition / Problems Studied
Modification(s)  
Health Type  Condition 
Patients  Type 2 Diabetes, (1) ICD-10 Condition: E119||Type 2 diabetes mellitus without complications,  
 
Intervention / Comparator Agent  
Type  Name  Details 
Intervention  Insulin Glargine and lixisenatide fixed ratio combination  FRC is supplied as a sterile aqueous solution in a pre filled disposable SoloStar® pen-injector 100 Uper mL insulin glargine with 50 or 33 μg per mL lixisenatide depending on the pen peach pen or olive pen respectively 
Comparator Agent  Insulin glargine LANTUS  Lantus is supplied as a sterile aqueous solution in a pre filled disposable SoloStar pen injector 100 U PER mL insulin glargine. 
 
Inclusion Criteria  
Age From  18.00 Year(s)
Age To  65.00 Year(s)
Gender  Both 
Details  1 Patients with type 2 diabetes mellitus or T2DM diagnosed for at least 1 year before the screening visit

2 At screening
Age should be greater or equal to 18 years of age to less than 65 years

HbA1c at screening visitgreater or equal to 7.5 percent or less than or equal to 10 percent

BMI greater than or equal to 19 kg per m2 and less than or equal to 40 kg per m2

3 Patients who have been treated with a basal insulin for at least 6 months before the screening visit, and who have been on a stable basal insulin regimen ie, type of insulin and time or frequency of the injection for at least 3 months before the screening visit. The stable total daily dose should be within the range of 15-40 U, both inclusive, on the day of screening, but individual fluctuations of plus or minus 20 percent within 2 months prior to screening are acceptable

4 For patients receiving basal insulin AND 1 or 2 oral anti-diabetic drugs or OADs the OAD doses must be stable during the 3 months before the screening visit. The OADs can be 1 to 2 out of
a metformin less than or equal to 1000mg per day or maximal tolerated dose

a sulfonylurea or SU

a glinide
•

a dipeptidyl peptidase 4 inhibitor or DPP 4 inhibitor or

a AGI

a thiazolidinedione


5 FPG less than or equals to 180 mg per dL at screening visit for patients receiving basal insulin in combination with 2 OADs or with 1 OAD other than metformin FPG les tan or equals to 200 mg per dL at screening visit for patients on basal insulin only or basal insulin plus metformin at screening visit
Note A second FPG test may be repeated between 5 to 15 days of the first FPG test to confirm the above FPG value.

6 Signed written informed consent.
Inclusion criteria for randomization at the end of the run-in period

7 HbA1c greater than or equal to 7 percent or les than or equal to 10 percent at visit 5 Week 1

8 Mean fasting SMPG is less tan or equal to 140 mg per dL calculated from all available minimum of 4 self-measurements values during the 7 days prior to randomization visit V6
Note: fasting SMPG on the day of randomization can be included if assessed before randomization.
 
 
ExclusionCriteria 
Details  1 Pregnancy or lactation

2 Women of childbearing potential not protected by highly effective contraceptive method of birth control

3 Use of oral or injectable glucose lowering agents other than those stated in the inclusion criteria in the 3 months before screening

4 Previous use of insulin regimen other than basal insulin eg, prandial or pre mixed insulin Note: Short term treatment due to intercurrent illness including gestational diabetes is allowed at the discretion of the investigator

5 History of discontinuation of a previous treatment with Glucagon Like Peptide 1 GLP 1 receptor agonist for safety or tolerability reasons or lack of efficacy

6 Laboratory findings at the screening visit, including

Amylase and or lipase less than 3 times the upper limit of the normal ULN laboratory range,
ALT or AST less than 3 ULN

Calcitonin greater or less than 20 pg per mL pmolper L
Positive serum pregnancy test

7 For patients taking metformin, any contraindication to metformin use, according to local labeling

8 For patient not treated with metformin at screening: severe renal function impairment with an estimated glomerular filtration rate eGFR less than 30 mLper minper 1.73m2 or end stage renal disease

9 History of allergic reaction to any GLP 1 receptor agonist in the past or to metacresol

10 Contraindication to use of insulin glargine according to local labeling.

11 History of hypersensitivity to insulin glargine or to any of the excipients

12 Personal or immediate family history of medullary thyroid cancer MTC or genetic condition that predisposes to MTC eg, multiple endocrine neoplasia syndromes

13 Clinically relevant history of gastrointestinal disease associated with prolonged nausea and vomiting, including but not limited to gastroparesis, unstable ie, worsening or not controlled ie, prolonged nausea and vomiting gastroesophageal reflux disease requiring medical treatment, within 6 months prior to the time of screening visit or history of surgery affecting gastric emptying.

14 History of pancreatitis unless pancreatitis was related to gallstones and cholecystectomy has been performed, pancreatitis during previous treatment with incretin therapies, chronic pancreatitis, pancreatectomy.

15 Average insulin glargine daily dose less than 20 U or greater than 50 U calculated for the last 3 days before Visit 6

15 Amylase and or or lipase less than 3 ULN at Visit 5 Week 1
 
 
Method of Generating Random Sequence   Computer generated randomization 
Method of Concealment   Centralized 
Blinding/Masking   Open Label 
Primary Outcome  
Outcome  TimePoints 
Mean change in HbA1c from baseline to week 24 in the 2 arms  Baseline to week 24 
 
Secondary Outcome  
Outcome  TimePoints 
1 Percentage of patients reaching HbA1c less than 7 percent at the end of week 24

2 Change in 2 hour PPG 2 hours after breakfast from baseline to week 24.

3 Change in body weight from baseline to Week 24

4 Percentage of patients reaching HbA1c less than 7percent with no body weight gain at Week 24

5 Percentage of patients reaching HbA1c target of less than 7 percent with no body weight gain and no hypoglycemia as defined in the evaluation criteria.




 		 Baseline to week 24 
 
Target Sample Size   Total Sample Size="254"
Sample Size from India="254" 
Final Enrollment numbers achieved (Total)= "0"
Final Enrollment numbers achieved (India)="247" 
Phase of Trial   Phase 3 
Date of First Enrollment (India)
Modification(s)  		 19/06/2018 
Date of Study Completion (India) 25/11/2019 
Date of First Enrollment (Global)  19/06/2018 
Date of Study Completion (Global) 25/11/2019 
Estimated Duration of Trial   Years="2"
Months="6"
Days="0" 
Recruitment Status of Trial (Global)
Modification(s)  		 Not Applicable 
Recruitment Status of Trial (India)  Completed 
Publication Details   none yet 
Individual Participant Data (IPD) Sharing Statement

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

Brief Summary  

This study is a randomized, open label, parallel group, multi-center trial comparing the efficacy and safety of Insulin Glargine and Lixisenatide Fixed Ratio Combination to Insulin Glargine, for 24 weeks in 254 patients with Type 2 Diabetes Patients that will be conducted in fifteen centers in India.  The primary objective is to demonstrate the superiority of the insulin glargine and lixisenatide fixed ratio combination FRC to insulin glargine by demonstrating change in glycosylated hemoglobin HbA1c over 24 weeks. The secondary objectives is to assess the effects of FRC in comparison with Insulin Glargine over 24 weeks for following parameters HBA1C, 2 Hour Post Prandial Glucose, Fasting Plasma Glucose, Weight Gain, Hypoglycemic events and 7-Point Self-Monitoring Plasma Glucose.

  
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