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CTRI Number  CTRI/2022/10/046634 [Registered on: 19/10/2022] Trial Registered Prospectively
Last Modified On: 17/10/2022
Post Graduate Thesis  No 
Type of Trial  Interventional 
Type of Study   Drug 
Study Design  Randomized, Parallel Group, Active Controlled Trial 
Public Title of Study   Study To Know The Use of Trelagliptin Tablets in Diabetes Patients 
Scientific Title of Study   A Phase III, Prospective, Multi-Center, Double Blind, Comparative, Active Controlled, Parallel Group, Randomized Study to Evaluate the Efficacy and Safety of Trelagliptin in Indian Adult Patients with Type 2 Diabetes Mellitus. 
Trial Acronym   
Secondary IDs if Any  
Secondary ID  Identifier 
HCR/III/TRELADM/12/2019 Version 2.0 Dated 08-02-2021  Protocol Number 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name   
Designation   
Affiliation   
Address 




 
Phone    
Fax    
Email    
 
Details of Contact Person
Scientific Query  
Name  Dr Sreenivasa Chary S 
Designation  General Manager 
Affiliation  Hetero Labs Limited 
Address  Clinical Development and Medical Affairs, 2nd Floor, 7-2-A2, Hetero Corporate, Industrial Estates, Sanath Nagar

Hyderabad
TELANGANA
500018
India 
Phone  040-23704923  
Fax    
Email  sreenivasa.chary@heterodrugs.com  
 
Details of Contact Person
Public Query  
Name  Dr Shubhadeep Sinha 
Designation  Sr. Vice President 
Affiliation  Hetero Labs Limited 
Address  Clinical Development and Medical Affairs, 2nd Floor, 7-2-A2, Hetero Corporate, Industrial Estates, Sanath Nagar

Hyderabad
TELANGANA
500018
India 
Phone  040-23704923  
Fax  040-23801902  
Email  sd.sinha@hetero.com  
 
Source of Monetary or Material Support  
Hetero Labs Limited, 7-2-A2, Industrial Estates, Sanath Nagar, Hyderabad - 500018, India. Tel: 91-40-23704923/24/25, Fax: 91-40-23801902 
 
Primary Sponsor  
Name  Hetero Labs Limited 
Address  7-2-A2, Industrial Estates, Sanath Nagar, Hyderabad - 500018, India. Tel: 91-40-23704923/24/25, Fax: 91-40-23801902 
Type of Sponsor  Pharmaceutical industry-Global 
 
Details of Secondary Sponsor  
Name  Address 
NIL  NIL 
 
Countries of Recruitment     India  
Sites of Study  
No of Sites = 5  
Name of Principal Investigator  Name of Site  Site Address  Phone/Fax/Email 
Dr SK Noushad Ali  ACSR Government Medical College & Hospital  Department of General Medicine, Room No 9,First Floor, Dargamitta, Nellore-524004
Nellore
ANDHRA PRADESH 		 9494828694

mddbnoal@gmail.com 
Dr Dibakar Biswas  Institute of Post Graduate Medical Education & Research  Department of Endocrinology, Room No 01, Ground Floor, 244 AJC Bose Road Kolkata-700020, West Bengal
Kolkata
WEST BENGAL 		 9433119518

drdibakarbiswas@gmail.com 
Dr Deo Nidhi Mishra  Nirmal Hospital  Department of Medicine, Room No 02, Ground Floor, Gate No.3, Opp.MLB Medical College, Jhansi(U.P)-284128
Jhansi
UTTAR PRADESH 		 9415031689

drmishra.nirmal@gmail.com 
Dr AGopal Rao   Rajiv Gandhi Institute of Medical Sciences  RIMS Govt.General Hospital, Department of General Medicine, OPD Room No 13, First Floor, Srikakulam-532001,AP,India
Srikakulam
ANDHRA PRADESH 		 9440122790

drgopalraoa@gmail.com 
Dr BalRam Sharma  SMS Hospital  Department of Endocrinology, Room No-42, Fourth Floor, Dhanvantri OPD Block, Jaipur-302004
Jaipur
RAJASTHAN 		 9660226666

drbalramendo@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 5  
Name of Committee  Approval Status 
Ethics Committee, S.M.S Medical College and Attached Hospitals  Submittted/Under Review 
Institutional Ethics Committee, Nirmal Hospital   Submittted/Under Review 
Institutional Ethics Committee Rajiv Gandhi Institute of Medical Sciences & RIMS Govt General Hospital  Submittted/Under Review 
Institutional Ethics Committee, ACSR Government Medical College & Hospital  Approved 
IPGMER&R research oversight committee  Submittted/Under Review 
 
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 
Comparator Agent  Alogliptin 25mg Tablet  Once Daily (before morning meals) For 24 Weeks 
Intervention  Trelagliptin 100mg Tablet  Once Weekly (before morning meals) For 24 Weeks 
Intervention  Trelagliptin 50mg Tablet  Once Weekly (before morning meals) For 24 Weeks 
 
Inclusion Criteria  
Age From  18.00 Year(s)
Age To  65.00 Year(s)
Gender  Both 
Details  1. Adult male or female patients aged of 18-65 years.
2. Patients willing to give written, signed, and dated informed consent to participate in the study.
3. Newly diagnosed patients with fasting plasma glucose ≥126 mg/dL (7.0 mmol/L) and 2-h post prandial plasma glucose ≥200 mg/dL (11.1 mmol/L) during oral glucose tolerance test (OGTT) at screening and end of run-in period.
4. Patients with Type 2 Diabetes Mellitus and having HbA1C of ≥7% at screening and end of run-in period.
5. Females of childbearing potential who are sexually active must agree to use barrier contraception and can neither be pregnant nor lactating from screening throughout the duration of the study.
6. Clinical laboratory evaluations (including clinical chemistry, hematology, and complete urinalysis) within the reference range for the testing laboratory or the results are deemed not clinically significant for inclusion into this study by the investigator.
 
 
ExclusionCriteria 
Details  1. Patient with Type 1 diabetes mellitus or secondary diabetes.
2. Patients with fasting plasma glucose ≥250 mg/dL or ≥13.9mmol/L or a history of severe hypoglycemia (blood sugar ≤50 mg/dL or ≤2.8mmol/L).
3. Patients with history of hypersensitivity reactions with DPP-4 inhibitors.
4. Patients received insulin within 8 weeks prior to screening.
5. Patients received treatment with a PPARγ agent (e.g., pioglitazone or rosiglitazone) or incretin mimetics (e.g., exenatide) within 12 weeks.
6. Patients with a body mass index (BMI) < 20 kg/m2 or > 43 kg/m2.
7. Patients with history of diabetic nephropathy, diabetic ketoacidosis, diabetic coma, hyperglycemia hyperosmolar state, retinopathy, neuropathy or other diabetic complications requiring treatment like severe symptomatic orthostatic hypotension, urinary retention, foot
ulcers, or gastric stasis.
8. Patients with clinically significant renal, hepatic, cerebrovascular, gastrointestinal, cardiovascular, nervous, malignancy, thyroid dysfunction, chronic uncontrolled systemic diseases like asthma, hypertension, collagen disorders and severe infection.
9. Patients with moderate (30 to < 60 ml/min/1.73 m2) to severe (15 to < 30 ml/min/1.73 m2) renal impairment, as determined at Screening, with GFR as calculated by the Cockcroft-Gault formula.
10. Patients with history of acute or chronic liver disease, and Aspartate aminotransferase (AST) or Alanine aminotransferase (ALT) >2.5 X ULN or total bilirubin >1.5 X ULN at the screening period.
11. Patients with active heart disease (including acute myocardial infarction, unstable angina within 6 months), congestive heart failure (NYHA class III or IV), percutaneous transluminal coronary angioplasty (PTCA), coronary artery bypass graft, hypertensive encephalopathy, cerebrovascular accident, or transient ischemic attacks.
12. Patients with history/ current 2nd or 3rd degree atrioventricular block, long QT syndrome or corrected QT interval QTc）>450msec or atrial fibrillation.
13. Patients with history of endocrine diseases such as hypercortisolism or polycystic ovary syndrome that may affect blood glucose levels.
14. Patients with history of pancreatitis, cholecystitis, gallstones and other digestive diseases.
15. Patients undergone weight loss surgery within 3 months before randomization or using weight-loss drugs (including traditional/herbal/ayurvedic/homeopathic) within 2 months.
randomization
16. Patients receiving oral or intravenous use of glucocorticoids or regular application (i.e continuous use more than one week within 4 weeks before randomization) with large doses of thiazide diuretics (hydrochlorothiazide, chlorothiazide, etc.).
17. Currently is participating in another investigational study or has participated in an investigational study within 90 days prior to randomization.
18. Any other serious disease or condition at screening (or randomization) that would compromise patient safety, might affect life expectancy, or make it difficult to successfully manage and follow the patient according to the protocol.
19. Patients with the current/past infections such as HIV, HBV and HCV. 
 
Method of Generating Random Sequence   Permuted block randomization, variable 
Method of Concealment   Centralized 
Blinding/Masking   Participant, Investigator, Outcome Assessor and Date-entry Operator Blinded 
Primary Outcome  
Outcome  TimePoints 
Mean Change in Glycosylated Haemoglobin (HbA1c) levels.  Day 1 and End of Week 24. 
 
Secondary Outcome  
Outcome  TimePoints 
Mean Change in Glycosylated Haemoglobin (HbA1c) levels.  Day 1 and End of Week 12. 
The proportion of patients achieving an HbA1C 7%.  End of Week 12 and 24. 
Mean Change in Fasting Plasma Glucose (FPG) levels.  Day 1, End of Week 12 and 24. 
Mean Change in postprandial plasma glucose (PPG) levels.  Day 1, End of Week 12 and 24. 
No of patients requiring rescue therapy.  Week 6, 12 and 24. 
Rate of hypoglycemic episodes.  Entire Study Period. 
Treatment emergent clinical & laboratory adverse events (TEAEs).  Entire Study Period. 
 
Target Sample Size   Total Sample Size="375"
Sample Size from India="375" 
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   Phase 3 
Date of First Enrollment (India)   20/10/2022 
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 
Estimated Duration of Trial   Years="2"
Months="0"
Days="0" 
Recruitment Status of Trial (Global)   Not Applicable 
Recruitment Status of Trial (India)  Not Yet Recruiting 
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 a double blind, double dummy, comparative, active-controlled, parallel group, randomized study to evaluate the efficacy and safety of Trelagliptin in Indian adult patients with Type 2 Diabetes Mellitus. Patients will be screened for study eligibility based on the inclusion and exclusion criteria. Patients eligible for the study will be randomized in 1:1:1 ratio among the study treatments based on the randomization schedule. 
All patients will receive study drug for the duration of 24 weeks. All patients will be followed up for maximum 36 weeks for efficacy and safety assessments. The study is expected to be completed in approximately 2 years after dosing of the first patient.
 
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