| CTRI Number |
CTRI/2024/10/075222 [Registered on: 14/10/2024] Trial Registered Prospectively |
| Last Modified On: |
02/05/2025 |
| Post Graduate Thesis |
No |
| Type of Trial |
Interventional |
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Type of Study
|
Drug |
| Study Design |
Other |
Public Title of Study
Modification(s)
|
A study to investigate safety and efficacy of iGlarLixi in adult patients with Type 2 diabetes mellitus. |
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Scientific Title of Study
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A Multicentre Phase IV single arm clinical trial to evaluate the safety and efficacy of a fixed ratio combination of Insulin Glargine and Lixisenatide in adult patients with Type 2 diabetes who are sub optimally controlled on oral anti-hyperglycemic drugs and/or basal Insulin/GLP-1 RA |
| Trial Acronym |
iGlarLixi Phase 4 study in India |
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Secondary IDs if Any
|
| Secondary ID |
Identifier |
| LPS18016, Amendment number 1.1, dated 18 JUN 2024 |
Protocol Number |
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Details of Principal Investigator or overall Trial Coordinator (multi-center study)
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| Name |
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| Designation |
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| Affiliation |
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| Address |
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| Phone |
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| Fax |
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| Email |
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Details of Contact Person
Scientific Query
|
| Name |
Dr Godhuli Chatterjee |
| Designation |
Senior Medical Advisor |
| Affiliation |
Sanofi Healthcare India Pvt. Ltd |
| Address |
Sanofi House CTS No.117 B L and T Business Park Saki Vihar Road Powai
Mumbai
MAHARASHTRA
400 072
India |
| Phone |
9930151289 |
| Fax |
|
| Email |
godhuli.chatterjee@sanofi.com |
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Details of Contact Person
Public Query
|
| Name |
Vibhawari Waghanna |
| Designation |
Clinical Project Leader |
| Affiliation |
Sanofi Healthcare India Pvt. Ltd |
| Address |
Sanofi House CTS No.117 B L and T Business Park Saki Vihar Road Powai
Mumbai
MAHARASHTRA
400 072
India |
| Phone |
7045402595 |
| Fax |
|
| Email |
vibhawari.waghanna@sanofi.com |
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Source of Monetary or Material Support
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| Sanofi Healthcare India Private limited, Sanofi House, C.T.S. No. 117/B, L&T Business Park, Saki Vihar Road, Powai, Mumbai, 400 072 |
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Primary Sponsor
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| Name |
Sanofi Healthcare India Private limited, |
| Address |
Sanofi House, C.T.S. No. 117/B, L&T Business Park, Saki
Vihar Road, Powai, Mumbai, 400 072 |
| Type of Sponsor |
Pharmaceutical industry-Global |
|
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Details of Secondary Sponsor
|
| Name |
Address |
| Sanofi Healthcare India Private Limited Sanofi House CTS NoB L and T Business Park |
Sanofi Healthcare India Private Limited, Sanofi House, CTS No.117-B, L and T Business Park
Saki Vihar Road, Powai, Mumbai |
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Countries of Recruitment
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India |
Sites of Study
Modification(s)
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| No of Sites = 12 |
| Name of Principal
Investigator |
Name of Site |
Site Address |
Phone/Fax/Email |
| Dr Bipin Kumar Sethi |
Care Hospital |
Care Outpatient Center, Department of Endocrinology, H No 8-2-620/ A-E, Ground Floor C Block, Road No 10, Banjara Hills, Hyderabad- 500034, Telangana
Hyderabad
TELANGANA |
9848021482
bipinkumarsethi@yahoo.co.uk |
| Dr Shailesh Lodha |
Eternal Hospital, A Unit of Eternal Heart Care Centre and Research Institute Private Limited |
Department of Endocrinology, 3A, Jagatpura Road, Near Jawahar Circle, Jaipur-302017
Jaipur
RAJASTHAN |
9829019055
saileshlodha@gmail.com |
| Dr Danendra Sahu |
Fortis Hospital |
Department of Endocrinology, A - block, Shalimar Bagh, New Delhi - 110088
New Delhi
DELHI |
9560597690
danendra.sahu@fortishealthcare.com |
| Dr Shivendra Verma |
GSVM medical college |
Room No. 137, 1st Floor, Department of Endocrinology, G.S.V.S. PGI., G.S.V.M. Medical College, Swaroop Nagar, Kanpur- 208002
Kanpur Nagar
UTTAR PRADESH |
8400331063
dr.shivendra@gmail.com |
| Dr Sujoy Ghosh |
Institute Of Post Graduate Medical Education & Research |
Department of Endocrinology and Metabolism, 244 A.J.C. Bose Road, Kolkata, West Bengal 700020
Kolkata
WEST BENGAL |
9674625823
drsujoyghosh2000@gmail.com |
| Dr Dange Amol Laxmanrao |
Lifepoint Multispeciality Hospital |
3rd Floor, Clinical Research Department, Sr. No. 145/1, Pune, 411057
Pune
MAHARASHTRA |
919823912040
amoldange298@gmail.com |
| Dr Pramila Kalra |
M S Ramaiah Medical College and Hospitals |
Department of Endocrinology, Ground floor, M S Ramaiah Nagar, MSRIT Post, Bangalore 560054
Bangalore
KARNATAKA |
9243257161
kalrapramila@gmail.com |
| Dr Ambrish Mithal |
Max Super specialty Hospital |
Department of Endocrinology, 2, Press Enclave Road, Saket, New Delhi-110017
New Delhi
DELHI |
9811019093
Ambrishmithal@hotmail.com |
| Dr Sanjay Bhatada |
Post Graduate Institute of Medical Education and Research |
Dept of endocrinology, 3rd floor, Research block B, Sector 12 ,Chandigarh - 160012
Chandigarh
CHANDIGARH |
9876602448
bhadadask@gmail.com |
| Dr Uday Phadke |
Sahyadri Super Speciality Hospitals |
Department of Endocrinology, Plot No. 30 C, Erandawane, Karve Road, Pune 411 004
Pune
MAHARASHTRA |
9822025180
uday@drudayphadke.com |
| Dr Sunil Jain |
TOTALL Diabetes Hormone Institute |
TOTALL Diabetes Hormone Institute Pvt. Ltd. A unit of Diabetes Thyroid Hormone Research Institute Pvt. Ltd., Ground floor, BCM Health Island PU-4, Scheme No. 54, Near Bombay Hospital, Behind Prestige Institute of Management, Indore- 452010
Indore
MADHYA PRADESH |
9826023182
sunilmjain@gmail.com |
| Dr Konatham Rambabu |
Visakha Institute of Medical Sciences |
Department of General Medicine, Visakha Institute of Medical Sciences (VIMS), Hanumanthavaka, Visakhapatnam-530040
Visakhapatnam
ANDHRA PRADESH |
91-9177747328
drkrambaburesearch@gmail.com |
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Details of Ethics Committee
Modification(s)
|
| No of Ethics Committees= 12 |
| Name of Committee |
Approval Status |
| Institutional Ethics Committee, Devki Devi Foundation |
Approved |
| Eternal Heart Care Center and Research Institute IEC, Jaipur |
Submittted/Under Review |
| Ethics committee of Diabetes Thyroid Hormone Research Institute Private Limited Indore |
Submittted/Under Review |
| Ethics Committee, M S Ramaiah Medical College and Hospitals, Bangalore |
Submittted/Under Review |
| Institutional Ethics Committee ,Visakha Institute of Medical Sciences |
Approved |
| Institutional Ethics Committee, Care Hospital, Hyderabad |
Submittted/Under Review |
| Institutional Ethics Committee, Ethics Committee, G.S.V.M, Kanpur |
Approved |
| Institutional Ethics Committee, Fortis Shalimar Bagh |
Approved |
| Institutional Ethics Committee, PGIMER, Chandigarh |
Submittted/Under Review |
| IPGMEandR Research Oversight Committee 244 Acharya JC Bose Road, Kolkata |
Submittted/Under Review |
| LPR Ethics Committee, Lifepoint Multispeciality Hospital, Pune |
Approved |
| Sahyadri Hospitals Ltd. Ethics committee, Pune |
Submittted/Under Review |
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Regulatory Clearance Status from DCGI
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Health Condition / Problems Studied
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| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: E119||Type 2 diabetes mellitus without complications, |
|
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Intervention / Comparator Agent
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| Type |
Name |
Details |
| Intervention |
iGlarLixi10-40 prefilled pen contains per mL 100 units insulin glargine and 50 mcg lixisenatide |
Frequency- iGlarLixi should be administered subcutaneously once a day within 1 hour prior to any meal.
Route of administration- Subcutaneous injection
Total duration of study intervention- 24 weeks of treatment period |
| Intervention |
iGlarLixi30-60 prefilled pen contains per mL 100 units insulin glargine and 33 mcg lixisenatide |
Frequency- iGlarLixi should be administered subcutaneously once a day within 1 hour prior to any meal.
Route of administration- Subcutaneous injection
Total duration of study intervention- 24 weeks of treatment period. |
| Comparator Agent |
NA |
NA |
|
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Inclusion Criteria
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| Age From |
18.00 Year(s) |
| Age To |
99.00 Year(s) |
| Gender |
Both |
| Details |
I 01. Participants must be ≥18 years of age, at the time of signing the informed consent.
I 02. Participants with Type 2 Diabetes diagnosed for at least 1 year at the time of screening on treatment with Metformin +/- OADs or basal insulin/GLP-1RA for a minimum period of 6 months prior to screening.
I 03. HbA1c between less than equal to 7.5percent and morethan equal to 10.5percent inclusive, during screening.
I 04. Participant with BMI more thansequalto 25 kg/m2 (as per Endocrine Society of India, Ref 12)
I 05. 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).
I 06. Signed informed consent |
|
| ExclusionCriteria |
| Details |
E 01. Type 1 Diabetes mellitus or any diabetes other than T2DM.
E 02. Prior use of any combination of Basal Insulin + GLP-1 RA Fixed Ratio or Free Combination, Premix Insulin, Basal bolus therapy
E 03. Basal insulin dose more than 50 U at screening.
E 04. 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 05. Known presence of factors that interfere with the HbA1c measurement (e.g., specific hemoglobin variants, hemolytic anemia) compromising the reliability of HbA1c assessment or medical conditions that affect interpretation of HbA1c results (e.g., blood transfusion or severe blood loss in the last 3 months prior to baseline, any condition that shortens erythrocyte survival).
E 07. Proliferative retinopathy or maculopathy requiring treatment according to the Investigator.
E 08. Use of weight loss drugs (including over the counter and herbal medications) within 12 Weeks prior to the screening visit, Use of systemic glucocorticoids (excluding topical application or inhaled forms) for 2 weeks or more within 8 weeks prior to screening visit.
E 09. Likelihood to require treatment prohibited by the protocol during the study.
E 10. 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.
E 11. Any specific situation during study implementation or course that may raise ethics considerations.
E 12. History of hypoglycemia unawareness
E 13. Patients with known hypersensitivity to lixisenatide, insulin glargine or to any of the inactive ingredients in the formulation.
E 14. History of drug or alcohol abuse within 6 months prior to screening visit.
E 15. Patient not suitable for participation, whatever the reason, as judged by the Investigator, or participants potentially at risk of noncompliance to the study procedures (eg, not willing and or not able to perform self-monitoring of plasma glucose, or to follow health care providers instructions on titration protocol) l.
E 16. Participants who withdraw consent during the screening (starting from signed ICF).
E 17. Participants unable to use a blood glucometer and accept to perform SMBG
E 18. Participants unable to use the diary and accept to report daily information as required
E 19. Participants with conditions or concomitant diseases making them non-evaluable for the study endpoints (eg, hemoglobinopathy or hemolytic anemia, receipt of blood or plasma products within the last 3 months prior to the screening visit).
E 20. Known history of drug or alcohol abuse within 6 months prior to the screening visit.
E 21. Any technical or administrative reason (eg, patient homeless) that made it impossible to enroll the patient in the study.
E 22. Participants who had taken other investigational drugs within 1 month or 5 half-lives from screening, whichever was longer. |
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Method of Generating Random Sequence
|
Not Applicable |
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Method of Concealment
|
Not Applicable |
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Blinding/Masking
|
Not Applicable |
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Primary Outcome
|
| Outcome |
TimePoints |
| To evaluate the safety of iGlarLixi in Adults with sub optimally controlledT2D with obesity despite treatment with Metformin +/- OADs and/or basal insulin/GLP-1 RA during 24 weeks of treatment period. |
At baseline, at week 24 and week 25 (follow up period). |
|
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Secondary Outcome
|
| Outcome |
TimePoints |
-To assess the efficacy of iGlarLixi on glycemic control (HbA1c/ FPG/ PPG /fasting SMPG) in obese Adults with sub optimally controlled T2D despite treatment with Metformin +/- OADs and/or basal insulin/GLP-1 RA after 24 weeks of treatment.
-To assess change in body weight after 24 weeks of treatment
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6 months |
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Target Sample Size
|
Total Sample Size="105"
Sample Size from India="105"
Final Enrollment numbers achieved (Total)= "Applicable only for Completed/Terminated trials"
Final Enrollment numbers achieved (India)="Applicable only for Completed/Terminated trials" |
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Phase of Trial
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Phase 4 |
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Date of First Enrollment (India)
|
28/10/2024 |
| 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 |
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Estimated Duration of Trial
|
Years="3"
Months="0"
Days="0" |
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Recruitment Status of Trial (Global)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Not Yet Recruiting |
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Publication Details
|
N/A |
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Individual Participant Data (IPD) Sharing Statement
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Will individual participant data (IPD) be shared publicly (including data dictionaries)?
Response - NO
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Brief Summary
|
|
This is an intervention, phase IV, single-arm
study to assess the safety and efficacy of iGlarLixi iGlarLixi in adult
patients with Type 2 diabetes.
Study details include:
• The study duration will be up to 27 weeks
• The treatment duration will be approximately
24 weeks
• The number of visits will be 16
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