CTRI/2023/02/049724 [Registered on: 14/02/2023] Trial Registered Prospectively
Last Modified On:
14/10/2024
Post Graduate Thesis
No
Type of Trial
PMS
Type of Study
Drug
Study Design
Single Arm Study
Public Title of Study
A research study to understand how oral semaglutide works in people with type 2 diabetes in India
Scientific Title of Study
A multicentre, prospective, non-interventional single-arm
study investigating clinical parameters associated with the
initiation of once-daily oral semaglutide in a real-world adult population with type 2 diabetes in India
Trial Acronym
Secondary IDs if Any
Secondary ID
Identifier
NCT05502562
ClinicalTrials.gov
NN9924-4960, v1.0 dated 08 April 2022
Protocol Number
U1111-1270-0826
UTN
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
Novo Nordisk India Private Limited,
Nxt Tower - 2, Floor 1 & 2
Embassy Manyata Business Park,
Nagavara Village, Kasaba Hobli, Bangalore –560045, India
No 3 & 4, Montieth Road, Egmore, Chennai - 600008
Chennai TAMIL NADU
9884200006
arun34@yahoo.com
Dr Nanditha Arun
Dr. A. Ramachandran’s Diabetes Hospitals
Anna Salai, 110, Mount Rd, Opposite ITC Grand Chola Hotel, Little Mount, Guindy, Chennai, Tamil Nadu 600032
Chennai TAMIL NADU
9841002813
nanditha_2005@hotmail.com
Dr Nikhil Bhagawat
Dr. Bhagwat’s Clinic
107 First Floor, Om Chambers, Kemaps Corner, Mumbai 400036
Mumbai (Suburban) MAHARASHTRA
9820238399
bhagwatnik@yahoo.co.in
Dr BM Makkar
Dr. Makkars Diabetes and Obesity Centre
A-5 B/122, PASCHIM VIHAR, Delhi - 110063 New Delhi DELHI
9910047419
drbmmakkar@gmail.com
Dr Nikhil Verma
ESI Medical College and Hospital, Faridabad
Esic Medical college and hospital Faridabad at NH-3, KL Mehta Rd, behind BK Hospital, New Industrial Town, Faridabad, Haryana 121012, New Delhi, Haryana, India 121012
Faridabad HARYANA
Dept of Medicine, S J road, Athgaon,781008
Kamrup ASSAM
9864061456
subhashdadhich3@gmail.com
Dr Sandeep Garg
Maulana Azad Medical College
Department Of Medicine, Maulana Azad Medical College, Bahadur Shah Zafar Marg, New Delhi Central, Delhi - 110002
New Delhi DELHI
9968604280
drsandeepgargmamc@gmail.com
Dr Ambrish Mithal
Max Super Specialty Hospital, Saket (A Unit of Devki Devi Foundation)
Max Super Speciality Hospital, Saket
(A Unit of Devki Devi Foundation)
2, Press Enclave Road ,Saket, New Delhi-110017
New Delhi DELHI
9811019093
ambrishmithal@maxhealthcare.com
Dr Sunil Mishra
Medanta Medicity
SECTOR 38, 122001
Gurgaon HARYANA
01244141414
docsunil09@yahoo.com
Dr Debasis Basu
METTA Clinic (a unit of Healious Global Pvt. Ltd.)
18/18 Dover Lane, 700039
Kolkata WEST BENGAL
9831256908
day.debasisb@gmail.com
Dr Pankaj Aneja
NAVEDA HEALTHCARE CENTRE
Sector 8/A-1/81, Rohini, 110085
New Delhi DELHI
9818548010
drpankajaneja@gmail.com
Dr Reema Kashiva
Noble Hospital Pvt. Ltd.
153A Magarpatta City Road, Hadapsar, 411013
Pune MAHARASHTRA
02066285568
reemakashiva@gmail.com
Dr Rajeev Chawla
North Delhi Diabetes Center
Jai Apartments, Metro Pillar #417 168, Pocket 35, Sector 9, Rohini, 110085
New Delhi DELHI
011-27562031
rajeevaastikchawla@yahoo.com
Dr Girish Parmar
Pai Poly Clinic
S V Road, Mumbai 400062 Mumbai MAHARASHTRA
9820718088
drgirish21@yahoo.co.in
Dr Dhruvi Hasnani
Rudraksha Institute of Medical Sciences Healthcare
Ghodasar, 382425
Ahmadabad GUJARAT
6351401109
dhruvi.hasnani@gmail.com
Dr Sandeep Bansal
Safdarjung Hospital
Vardhaman Mahavir Medical College & Safdarjung Hospital,Specialty block, 7th floor,Ansari Nagar East, Near to AIIMS Metro Station,New Delhi, Delhi 110029
New Delhi DELHI
9810543368
drsbansal2000@yahoo.com
Dr Hemant Phatale
Samrat Endocrine Centre
60, New Rokadiya Hanuman Colony, Aurangabad. Maharashtra. 431001
Aurangabad MAHARASHTRA
02402341894
hpphatale@gmail.com
Dr Kamal Sharma
Sanjivani Super Speciality Hospital
Uday Park Society, Sunrise Park Road, Near 1, Vastrapur, 380015 Ahmadabad GUJARAT
"Aurangabad Health Care and Research LLP IEC Aurangabad Health Care and Research LLP Shop No.126,CTS No.12482/1 Chetan Trade Centre, Opp. S.F School, Jalna Road Aurangabad Aurangabad Maharashtra – 431001"
ACE Independent Ethics Committee, Top Floor B Portion, Nandanam Building, No. 1, B Channasandra, OMBR 5th Main Road, Bangalore- 560043, Karnataka, India.
Submittted/Under Review
Chellaram Diabetes Institute lalani Quantum Pune bangalore Highway Bavdhan Budruk Pune-411021 Maharashtra India
Approved
ECRC-HEC Marwari Hopitals Sati Joymati Road Athgaon Guwahati Kamrup Metropolitan Assam - 781008 India
Approved
Ethics committee of India Diabetes Research Foundation & Dr A Ramachandran’s Diabetes Hospitals, No 110, Anna Salai, Guindy, Tamil Nadu - 600 032
Approved
Ethics committee of India Diabetes Research Foundation & Dr A Ramachandran’s Diabetes Hospitals, No 110, Anna Salai, Guindy, Tamil Nadu - 600 032
Approved
Good Society for Ethical Research (GSER) D/129, Opposite - Durga Mandir, Street Number 13, Ashok Nagar, Shahdara, Delhi, 110093
Approved
Good Society for Ethical Research (GSER) D/129, Opposite - Durga Mandir, Street Number 13, Ashok Nagar, Shahdara, Delhi, 110093
Approved
Good Society for Ethical Research (GSER) D/129, Opposite - Durga Mandir, Street Number 13, Ashok Nagar, Shahdara, Delhi, 110093
Approved
HP Poddar Memorial Clinic And Nursing Home 56H, Beleghata Main Rd, Subhas Sarobar Park Phool Bagan, Beleghata, Kolkata Kolkata Kolkata West Bengal - 700010 India
Approved
Hurip Independent Bioethics Committee
Approved
Hurip Independent Bioethics Committee
Approved
Hurip Independent Bioethics Committee TAAB BIOSTUDY SERVICES, 69 Ibrahimpur Road Jadavpur Kolkata Kolkata West Bengal - 700032 India
Approved
Hurip Independent Bioethics Committee TAAB BIOSTUDY SERVICES, 69 Ibrahimpur Road Jadavpur Kolkata Kolkata West Bengal - 700032 India
Approved
Independent Ethics Committee CR India Independent Research Ethics Society 119 Rajdanga Gold Park Tribarna Sangha Kasba Kolkata Kolkata West Bengal 700107 India
Submittted/Under Review
Institutional Ethics Committee
Approved
Institutional Ethics Committee Chitkara University, Chitkara University NH64 Rajpura Patiala, Punjab - 140401 India
INSTITUTIONAL ETHICS COMMITTEE Kokilaben Dhirubhai Ambani Hospital & Medical Research Institute Rao saheb Achutrao Patwardhan Marg, Four Bunglows Andheri West Mumbai Mumbai City Maharashtra - 400053 India
Submittted/Under Review
Institutional Ethics Committee, Devki Devi Foundation- Service Floor, Office of Ethics Committee, East Block, Next to Conference Room, 2, Press Enclave, Road, Saket, New Delhi- 110017, India
Approved
Institutional Ethics Committee, GMC, Nagpur, Government Medical College, Nagpur, Department Of Pharmacology, Government Medical,Col Medical Square Nagpur Nagpur Nagpur Maharashtra - 440003 India
Submittted/Under Review
Institutional Ethics Committee, Government Medical College, Medical college junction -17, Kozhikode - 673008
Approved
Institutional Ethics Committee, Srirama Chandra Bhanja Medical College and Hospital, Manglabag, Mangalabag, Cuttack, Odisha 753007
Approved
Institutional Ethics Committee-Clinical Studies Apollo Hospital Enterprises Limited, review of the study No 21, Greams Lane, Off Greams Road, Chennai-600006, India
IPGMEandR Resaerch Oversight Committee IPGMEandR, 244 Acharya J. C. Bose Road - Kolkata Kolkata West Bengal - 700020 India
Submittted/Under Review
Karkinos Healthcare Independent Ethics Committee KarkinosHealthcare Technologies Kerala Private Ltd Karkinos Healthcare Technologies Kerala Pvt LTD Kattikaran House 7/3, SRA 30, CRASH Road Ernakulam Ernakulam Kerala - 682021 India
Submittted/Under Review
NOBLE HOSPITAL INSTITUTIONAL ETHICS COMMITTEE Noble Hospitals Pvt. Ltd. ,Room No 5, Clinical Research Department Noble Annex, 153 A, Magarpatta City Road, Hadapsar Hadapsar (India) - 411013 India
Approved
PRANAV DIABETES CENTER ETHICS COMMITTEE
Approved
Royal Pune Independent Ethics Committee (RPIEC), Office No 13, Anupam Arcade, Opp. Snake Park, Pune- Satara Road, Katraj | Pune | 411046, Maharashtra, India.
Sanjivani Hospital Ethics Committee, Sanjivani Super Speciality Hospital Pvt.Ltd., 1, Uday Park Society, Near Sunrise ParkVastrapur, Ahmedabad, Gujarat - 380015 India
Approved
Scientific Research and Ethical Review Committee
Approved
Shrey Hospital Institutional Ethics Committee , Shrey Hospital Private Limited 270/B/5 Near AMCO Bank, Stadium Circle Navrangpura Ahmedabad Gujarat, 380009
Approved
ShriBDMehtaMahavirHeartInstitute Ethics Committee , Shri B D Mehta Mahavir Heart Institute, Shree Mahavir Health Campus, Opp. Vanita Vishram Ground Athwagate, Ring Road Surat Surat Gujarat -395001 India
Approved
SRI RAMAKRISHNA HOSPITAL ETHICAL COMMITTEE SRI RAMAKRISHNA HOSPITAL 395, SAROJINI NAIDU ROAD SIDDHAPUDUR COIMBATORE Coimbatore Tamil Nadu - 641044 India"
Submittted/Under Review
THAKERSHY CHARITABLE TRUST ETHICSCOMMITTEESUSHRI JASUMATIBEN SHANTILAL SURTI CHARITABLE GENERALHOSPITAL, OPPOSITE VIMANAGAR, NEAR SHIVRANJANI CROSS ROADSATELLITE, AHMEDABAD- 380015 GUJARAT, INDIA
Zydus Hospital Ethics Committee Zydus Hospitals & Healthcare Research Pvt Ltd. Zydus Hospital Road, Near Sola Bridge S. G. Highway Thaltej Ahmedabad Gujarat - 380054 India
Dose: 3mg, 7mg and 14 mg,
Patients will be treated with commercially available oral semaglutide according to local label and
routine clinical practice at the discretion of the treating physician.
Frequency: Once daily
Route of administration: Oral route
Total duration: Upto 44 weeks.
Comparator Agent
Not Applicable
Not Applicable
Inclusion Criteria
Age From
18.00 Year(s)
Age To
99.00 Year(s)
Gender
Both
Details
1. Signed consent obtained before any study-related activities (study-related activities are any
procedure related to recording of data according to the protocol).
2. Diagnosed with T2D.
3. The decision to initiate treatment with commercially available oral semaglutide has been made
by the patient/Legally Acceptable Representative (LAR) and the treating physician based on
local label before and independently from the decision to include the patient in this study.
4. Male or female, age above or equal to 18 years at the time of signing informed consent.
5. Available HbA1c value ≤ 90 days prior to the ‘Informed Consent and Treatment Initiation visit’
(V1) or HbA1c measurement taken in relation with the ‘Informed Consent and Treatment
Initiation visit’ (V1) if in line with local clinical practice.
6. Treatment naïve to injectable glucose-lowering drug(s). An exception is short-term insulin
treatment for acute illness for a total of < 14 days.
ExclusionCriteria
Details
1. Previous participation in this study. Participation is defined as having given informed consent in this study.
2. Any prior or current use of oral semaglutide.
3. Hypersensitivity to oral semaglutide or to any of the excipients.
4. Treatment with any investigational drug within 30 days prior to signing of informed consent.
5. Participation in any clinical trial of an approved or non-approved investigational medicinal
product within 30 days prior to signing of informed consent.
6. Mental incapacity, unwillingness or language barriers precluding adequate understanding or
cooperation.
Simultaneous participation in a trial with the primary objective of evaluating an approved or non-approved investigational medicinal product for prevention or treatment of coronavirus disease 2019 (COVID-19) or post-infectious conditions is allowed if the last dose of the investigational
medicinal product has been received more than 30 days prior to signing of informed consent
Method of Generating Random Sequence
Other
Method of Concealment
Other
Blinding/Masking
Open Label
Primary Outcome
Outcome
TimePoints
To investigate the glycaemic control in adult
patients with type 2 diabetes (T2D) who have not previously been treated with injectable glucose-lowering medication and who initiate treatment with oral semaglutide.
From baseline End of study (V3)
Secondary Outcome
Outcome
TimePoints
To investigate mean changes in body
weight in adult patients with T2D who have not previously been treated with injectable glucose-lowering medication and who initiate treatment with oral semaglutide.
From baseline End of study (V3)
HbA1c less than 7% at End of Study visit (V3)
End of study visit (V3)
Target Sample Size
Total Sample Size="388" Sample Size from India="388" Final Enrollment numbers achieved (Total)= "388" Final Enrollment numbers achieved (India)="388"
Individual Participant Data (IPD) Sharing Statement
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
Response - NO
Brief Summary
This is a 34 to 44-weeks, multicentre, prospective, open-label, non-interventional, single-arm study, assessing clinical parameters associated with the initiation of once-daily oral semaglutide in adult patients with T2D who have not previously been treated with injectable glucose-lowering medication in routine clinical practice. Data will be obtained through primary data collection. The decision to initiate treatment with oral semaglutide is at the treating physician’s discretion and is clearly separated from the decision to include the patient in the study. Furthermore, no additional diagnostic or monitoring procedures outside of usual clinical practice will be applied to the patients. Planned time period for the study: Sep 2022 to Sep 2023. The study population will consist of male or female patients (18 years or older at the time of signing informed consent) diagnosed with T2D and without any prior or current use of oral semaglutide.