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CTRI Number  CTRI/2021/02/031350 [Registered on: 17/02/2021] Trial Registered Prospectively
Last Modified On: 02/09/2026
Post Graduate Thesis  No 
Type of Trial  Observational 
Type of Study   Follow Up Study 
Study Design  Randomized, Parallel Group, Active Controlled Trial 
Public Title of Study   A multinational,randomized open-label,parallel-group, active-controlled,two-arm, long-term morbidity and mortality trial involving intensive preventive therapy (high dose renin-angiotensin-aldosterone system inhibitors [RAASi],beta-blockade,sodium-glucoseco-transporter 2 
Scientific Title of Study   A multinational, randomized open-label, parallel group, active-controlled, two-arm, long-term morbidity and mortality trial involving intensive preventive therapy (high dose renin-angiotensin-aldosterone system inhibitors [RAASi], beta-blockade, sodium-glucose co-transporter 2 inhibitors [SGLT2i]) among biomarker (N-terminal pro-B-type natriuretic peptide, NT-proBNP)-identified high risk type 2 DM patients without pre-existing cardiovascular disease 
Trial Acronym  ADOPT 
Secondary IDs if Any
Modification(s)  
Secondary ID  Identifier 
ADOPT169609_Protocol Version 2.7, dated 18 Mar 2022  Protocol Number 
ADOPT169609_Protocol Version 2.8, dated 13 Oct 2022  Protocol Number 
ADOPT169609_Protocol Version 3.0, dated 14 Sep 2023  Protocol Number 
ADOPT169609_Protocol Version 4.0, dated 22 May 2025  Protocol Number 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
Modification(s)  
Name  DR VIJAY KUMAR CHOPRA 
Designation  Director, Heart Failure Programme and research 
Affiliation  Max Super Speciality Hospital 
Address  1-2, Press Enclave Road, Saket, New Delhi 110017

South
DELHI
110017
India 
Phone  919650896800  
Fax  01126510050  
Email  vijay.chopra@maxhealthcare.com  
 
Details of Contact Person
Scientific Query
Modification(s)  
Name  DR VIJAY KUMAR CHOPRA 
Designation  Director Heart Failure Programme and research 
Affiliation  Max Super Speciality Hospital 
Address  1-2, Press Enclave Road, Saket, New Delhi 110017

South
DELHI
110017
India 
Phone  919650896800  
Fax  01126510050  
Email  vijay.chopra@maxhealthcare.com  
 
Details of Contact Person
Public Query
Modification(s)  
Name  DR VIJAY KUMAR CHOPRA 
Designation  Director Heart Failure Programme and research 
Affiliation  Max Super Speciality Hospital 
Address  1-2, Press Enclave Road, Saket, New Delhi 110017
Department of Cardiology Max Super Speciality Hospital (East Block), Saket, New Delhi-110017, South DELHI
South
DELHI
110017
India 
Phone  919650896800  
Fax  01126510050  
Email  vijay.chopra@maxhealthcare.com  
 
Source of Monetary or Material Support  
National Heart Centre of Singapore PTE LTD 31 Third Hospital Avenue 03-03 Bowyer Block Singapore 168753 
 
Primary Sponsor
Modification(s)  
Name  National Heart Centre of Singapore Pte Ltd 
Address  National Heart Centre of Singapore Pte Ltd (UEN 199801148C), of 10 Hospital Boulevard, #19-01, Singapore 168582 (‘NHCS”) 
Type of Sponsor  Research institution and hospital 
 
Details of Secondary Sponsor  
Name  Address 
NIL  NIL 
 
Countries of Recruitment
Modification(s)  		   United Arab Emirates
China
India
Malaysia
Singapore
Taiwan  
Sites of Study
Modification(s)  
No of Sites = 7  
Name of Principal Investigator  Name of Site  Site Address  Phone/Fax/Email 
Dr Gurpreet Singh Wander  Dayanand Medical College and Hospital, Ludhiana  Dayanand Medical College and Hospital, Department: Unit Hero DMC Heart Institute, Tagore Nagar, Ludhiana- 141001 Ludhiana PUNJAB
Ludhiana
PUNJAB 		 911612304282-88
911612309595
drgswander@yahoo.com 
Dr Hemant Gupta  Grant Govt. Medical College and Sir J.J. Group of Hospitals  Byculla, Mumbai, 400008, India
Mumbai
MAHARASHTRA 		 9870456888
02223735559
drhemantgupta2023@gmail.com 
Dr Muthu Ramu  Madras Diabetes Research Foundation, Tamil Nadu  Madras Diabetes Research Foundation, No 4, Conran Smith Road, Gopalapuram, Chennai - Tamilnadu- 600 086. India
Chennai
TAMIL NADU 		 9840923632
914428350935
clinicaltrialsramu@gmail.com 
DR VIJAY KUMAR CHOPRA  Max Super Speciality Hospital  Department of Cardiology Max Super Speciality Hospital (East Block), Saket, New Delhi-110017 South DELHI
South
DELHI 		 919650896800
911126510050
vijay.chopra@maxhealthcare.com 
Dr Reema Kashiva  Noble Hospitals Pvt Ltd. Pune  Noble Hospitals Pvt Ltd., No.153/A, Magarpatta City Road, Hadapsar, Pune-411013, India
Pune
MAHARASHTRA 		 919922618286

reemkashiva@gmail.com 
Dr Shantanu Sengupta  Sengupta Hospital & Research Institute  Department of Clinical Research Ravinagar Square , Nagpur 440033 , Maharashtra , India Nagpur MAHARASHTRA
Nagpur
MAHARASHTRA 		 917122532697
917122565597
senguptasp@gmail.com 
Dr JITENDRA PAL SINGH SAWHNEY  SIR GANGA RAM HOSPITAL  Department of Clinical research Sarhadi Gandhi Marg, Old Rajinder Nagar, Rajinder Nagar, New Delhi, Delhi 110060 Central DELHI
Central
DELHI 		 911142251547
911166173891
jpssawhney@yahoo.com 
 
Details of Ethics Committee
Modification(s)  
No of Ethics Committees= 7  
Name of Committee  Approval Status 
Drug Trial Ethics Committee (DTEC) Dayanand Medical College and Hospital [Site 302]  Approved 
Ethics Committee Sir Ganga Ram Hospital [Site 301]  Approved 
Institutional Ethics Committee New Healthcare Nursing Home [SIte 307]  Approved 
Madras Diabetes Research Foundation Institutional Ethics Committee [Site 303]  Approved 
Max Super Speciality Hospital, Institutional Ethics Committee [Site 305]  Approved 
Noble Hospital Institutional Ethics Committe [Site 306]  Approved 
Sengupta Hospital and Research Institute Ethics Committee [Site 304]  Approved 
 
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
Modification(s)  
Type  Name  Details 
Comparator Agent  Control group  Patients receive standard therapy where the use of RAASi and beta-blockers are allowed with the exception at maximal dosage. Prescription or up-titration during the study drugs listed under Intensive Treatment is not encouraged. If investigators/ treating physicians feel that further prescription or up-titration is required, a thorough justification is mandatory. Unless there is clinically irrefutable reason, every attempt should be made to use other blood pressure lowering drugs than RAASi or beta-blockers, as well as glucose lowering drugs other than SGLT2i, in the control group. 
Intervention  intensive preventive therapy  Adults: NT-proBNP greater than 100 pg/mL Study period: 2 years recruitment and 2 years follow-up.  
 
Inclusion Criteria
Modification(s)  
Age From  40.00 Year(s)
Age To  99.00 Year(s)
Gender  Both 
Details  1. Type 2 diabetes for at least six months as defined by the American Diabetes Association Standards of
Medical Care in Diabetes 2019 criteria and/or receiving anti-diabetic therapy for the established diagnosis.
- Fasting plasma glucose greater than or equal to 126 mg/dL or 7.0 mmol per L. Fasting is defined as no caloric intake for at least 8hrs,
OR
- 2 hour postprandial glucose greater than or equal to 200 mg per dL or 11.1 mmol per L during OGTT. The test should be performed as described by the WHO, using a glucose load containing the equivalent of 75 g anhydrous glucose dissolved in water,
OR
- A1C greater than or equal to 6.5 percentage 48 mmol per mol. The test should be performed in a laboratory using a method that is NGSP certified and standardized to the DCCT assay,
OR,
- In a patient with classic symptoms of hyperglycemia or hyperglycemic crisis, a random plasma glucose greater than or equal to 200mg per dL or 11.1 mmol per L in absence of unequivocal hyperglycemia, diagnosis requires two abnormal test results from the same sample or in two separate test
samples
2. Greater than or equal to 40 years of age, men or women
3. No known cardiovascular disease defined as known coronary stenosis greater than 70%, reduced left ventricular ejection fraction less than 40%, or a history of myocardial infarction or coronary revascularization or heart failure hospitalization or stroke or prior non-traumatic lower limb amputation or angioplasty
4. NT proBNP greater than 100 pg per mL
5. Written informed consent 
 
ExclusionCriteria 
Details  1. History of hypersensitivity to any of the drugs investigated as well as known or suspected contraindications to the study drugs or previous history of intolerance to high dose of RAASi or beta-blocker in the absence of any other blood pressure lowering drugs
2. Patients already on a maximum dose of RAASi or beta-blocker
3. History of DM ketoacidosis or Type 1 DM
4. eGFR less than 30ml per min per 1.73m2. eGFR cut-off as per local approvals for SGLT2 inhibitor use. Results from clinical tests done within 6 months of the visit date can be used.
5. Symptomatic hypotension and/or Visit 1 systolic blood pressure SBP less than 100mmHg
6. Symptomatic bradycardia, high-grade AV blocks Grade 2 and 3 and or Visit 1 heart rate HR less than 60bpm.
7. Any disease other than diabetes lowering the patient’s life expectancy to less than two years
8. Chronic infections E.g. chronic cystitis, recurrent urinary tract infections or malignancies or uncontrolled thyroid disorder or liver disease
9. Systemic treatment with corticosteroids.
10. Pregnant or nursing women
11. Any other clinical condition that might affect patients safety during trial, at the investigators discretion
12. Participation in an investigational drug trial 
 
Method of Generating Random Sequence
Modification(s)  		 Other 
Method of Concealment   Not Applicable 
Blinding/Masking   Open Label 
Primary Outcome
Modification(s)  
Outcome  TimePoints 
1) All-cause death
2) First CV Hospitalization
3) CV elective and urgent visits
4) Kidney function
a. UACR change
b. Presence of CKD (eGFR less than 60 mL/min/1.73 m2) at 2 years
c. Annualized eGFR slope
5) NT-proBNP % change from baseline to 1 year
6) HbA1c control at 2 years (defined at 7% threshold)
7) Blood pressure control at 2 years
a. Defined at systolic blood pressure 120 mmHg threshold
b. Defined at systolic blood pressure 130 mmHg threshold 		 Visit 1:
Screening,
Interim visits for the Intensive treatment group only,
Visit 2 (3 months ± 1 week),
Visit 3 (12 months ± 2 weeks),
Visit 4 (24 months ± 2 weeks),
Long-term follow-up (LTFU) (36 and 48 months ± 3 weeks).
 
 
Secondary Outcome
Modification(s)  
Outcome  TimePoints 
Secondary outcome:
1) Composite outcome of all-cause death or first CV hospitalization
2) Composite outcome of CV death or first CV hospitalization
3) Composite outcome of CV death or first major adverse cardiovascular event (stroke/ myocardial infarction/ heart failure events)
4) Health economic analysis (cost-effectiveness of intervention considering both life-years & quality of life adjusted life years)
5) Other predefined biomarkers (Section 4.2 on plasma/serum & urinary biomarkers)

Safety assessment:
1) Systolic & diastolic BP
2) Heart rate
3) Laboratory values
4) Electrocardiography (ECG)
5) eGFR
6) UACR
7) HbA1c
8) Adverse events profile including hypo-/ hyperglycaemic events, genital infections/diabetic ketoacidosis/acute kidney injury/bone fractures
9) Non-traumatic lower limb amputations or lower limb angioplasty 		 Visit 1:
Screening,
Interim visits for the Intensive treatment group only,
Visit 2 (3 months ± 1 week),
Visit 3 (12 months ± 2 weeks),
Visit 4 (24 months ± 2 weeks),
Long-term follow-up (LTFU) (36 & 48 months ± 3 weeks). 
 
Target Sample Size
Modification(s)  		 Total Sample Size="739"
Sample Size from India="281" 
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)
Modification(s)  		 20/01/2022 
Date of Study Completion (India) Applicable only for Completed/Terminated trials 
Date of First Enrollment (Global)  14/07/2020 
Date of Study Completion (Global) Applicable only for Completed/Terminated trials 
Estimated Duration of Trial   Years="4"
Months="0"
Days="0" 
Recruitment Status of Trial (Global)
Modification(s)  		 Closed to Recruitment of Participants 
Recruitment Status of Trial (India)  Closed to Recruitment of Participants 
Publication Details   NIL 
Individual Participant Data (IPD) Sharing Statement

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

Response - NO
Brief Summary
Modification(s)  
This study is a prospective multinational randomized open-label, parallel group, active-controlled, two-arm, long-term morbidity and mortality trial to evaluate safety and efficacy of intensive preventive therapy (high dose of RAS antagonists, high dose of beta-blockers [unless contraindicated] and preferential usage of SGLT2i) compared to standard care among DM patients. without any known cardiovascular disease (defined as known coronary stenosis >70%, reduced left ventricular ejection fraction <40%, or a history of myocardial infarction/ coronary revascularization/heart failure hospitalization/stroke/ prior non-traumatic lower limb amputations or angioplasty).
Upon completing full screening for eligibility, patients will be randomized into intensive preventive therapy or control arm at Visit 1. Subjects in the intensive preventive therapy arm alone will have interim visits (between Visits 1- 2) for up-titration of RAASi/beta-blocker (unless contraindicated) and preferential initiation/continuation of SGLT2i. Patients will be assessed (vital signs and blood chemistry) for up to 2 years (Visit 1-4) and subsequently followed up through population register or telephone contact until study is completed (See Section 4.1 on Visit schedule). For patients on intensive arm treatment, physicians are to maintain SGLT2i dosage as well as up titrated/max dose of RAASi and beta-blockers, at their discretion. This is applicable until end of study or end of LTFU, whichever is later. The frequency of follow-up for these patients will be as clinical indicated. 

Remarks:
Site - Grant Govt. Medical College and Sir J.J. Group of Hospitals has been closed on 30 Mar 2024. EC has acknowledged site closure notification on 18 Apr 2024. Site EC name is IEC of New Healthcare Nursing Home (EC registration number - ECR/1388/Inst/MH/2020).

Closed recruitment on 31 Dec 2024. The study currently in maintenance phase.
 
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