CTRI/2023/01/048826 [Registered on: 09/01/2023] Trial Registered Prospectively
Last Modified On:
10/10/2024
Post Graduate Thesis
No
Type of Trial
Interventional
Type of Study
Drug
Study Design
Randomized, Parallel Group, Active Controlled Trial
Public Title of Study
A clinical study to evaluate the efficacy and safety of Trelagliptin tablets (1 tablet in a week) in comparison to Vildagliptin tablets (daily 2 tablets) in patients with type 2 diabetes.
A randomized, multi-centric, comparative, parallel, open-label, active-controlled, Phase III trial study to demonstrate the non-inferiority of Trelagliptin 100mg once weekly to Vildagliptin 50 mg twice daily in the management of Type-2 Diabetes Mellitus.
Trial Acronym
Secondary IDs if Any
Secondary ID
Identifier
CT/ND/58/2022
DCGI
ZUV/Trelagliptin/2022, Ver. 1.0 Dated 23 Aug 2022
Protocol Number
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
Name
Dr Bhupesh Dewan
Designation
Director, Medical Services
Affiliation
Zuventus Healthcare Limited
Address
Department of Medical Services, Zuventus Healthcare Ltd., Zuventus House, Plot Y2, CTS No.: 358/A2, Near Nahur Railway Station, Nahur (W), Mumbai, 400078 Maharashtra
Mumbai MAHARASHTRA 400078 India
Phone
Fax
Email
bhupesh.dewan@zuventus.com
Details of Contact Person Scientific Query
Name
Dr Bhupesh Dewan
Designation
Director, Medical Services
Affiliation
Zuventus Healthcare Limited
Address
Department of Medical Services, Zuventus Healthcare Ltd., Zuventus House, Plot Y2, CTS No.: 358/A2, Near Nahur Railway Station, Nahur (W), Mumbai, 400078 Maharashtra
Mumbai MAHARASHTRA 400078 India
Phone
Fax
Email
bhupesh.dewan@zuventus.com
Details of Contact Person Public Query
Name
Dr Bhupesh Dewan
Designation
Director, Medical Services
Affiliation
Zuventus Healthcare Limited
Address
Department of Medical Services, Zuventus Healthcare Ltd., Zuventus House, Plot Y2, CTS No.: 358/A2, Near Nahur Railway Station, Nahur (W), Mumbai, 400078 Maharashtra
OPD No. 3, Ground Floor, Department of Medicine, Block C, Pranaam Hospital, H No 1-58/6/40&41, Madinaguda, Miyapur Hyderabad, Telangana 500050 Hyderabad TELANGANA
8333002727
krishnaprasadanne@gmail.com
Dr Shrikant Kasar
7-Orange Hospital
Diabetic Ward, OPD 1, Ground floor, Department of Medicine, 7-Orange Hospital, Pawana Nagar, Next to Jain School, Chinchwad, Pune, Maharashtra 411033 Pune MAHARASHTRA
9657746968
drshrikantkasar@gmail.com
Dr Hemant Gupta
Grant Govt. Medical College and Sir J.J. Group of Hospitals
OPD 20, 1st Floor, Department of Medicine, Main OPD Building, J.J. Marg, Nagpada, Mumbai, Maharashtra 400008
Mumbai MAHARASHTRA
9870456888
drhemantgupta@hotmail.com
Dr Sachin Hoskatti
Karnataka Institute of Medical Sciences
Dept of Medicine, Vidyanagar, Hubballi, Dharwad, Karnataka, 580029 Dharwad KARNATAKA
7676870007
hoskatti@gmail.com
Dr Kekathi Vidya Sagar
Kurnool Medical College and Govt. General Hospital
OPD No. 9, Ground floor, Department of Medicine, Trauma Care Building, Budhawara Peta, Kurnool, Andhra Pradesh 518002 Kurnool ANDHRA PRADESH
9440403270
vidyasagarkekathi37@gmail.com
Dr Aishwarya Krishnamurthy
Max Super Speciality Hospital
Ward No. 5, 5th floor, Department of Endocrinology, Max Super Speciality Hospital (A unit of Crosslay Remedies Limited), W-3, Sector 1, Vaishali, Ghaziabad, Uttar Pradesh, 201012 Ghaziabad UTTAR PRADESH
9855480353
aishwaryakr1410@gmail.com
Dr Manish Kumar Singh
Maya Hospital and Maternity Centre
Maya Hospital and Maternity Centre, 343 E-block, Panki, Kanpur, Uttar Pradesh- 208020 Kanpur Nagar UTTAR PRADESH
7007590702
drmanishkumar820@gmail.com
Dr Rashmi Sinha
Rajendra Institute of Medical Sciences
1st Floor, Department of Medicine, Old Building, Rajendra Institute of Medical Sciences, Bariatu, Near Bariatu Thana, Ranchi, Jharkhand 834009
Ranchi JHARKHAND
9431355691
drrashmi1967@gmail.com
Dr Sirshendu Pal
Roy Nursing Home
1st Floor, Ward 12, Tilak Road, Hakim Para, Siliguri, West Bengal 734001, India Darjiling WEST BENGAL
1. Adults aged ≥18 years.
2. Naïve patients diagnosed with Type 2 diabetes mellitus.
3. Patients with glycosylated hemoglobin (HbA1c) ranged in 6.5-10% (both inclusive) at screening.
4. Patients with BMI ranged from 19-35 kg/m2 (both inclusive).
5. Patients who are willing to participate voluntarily and provide written informed consent
ExclusionCriteria
Details
1. Patients with known hypersensitivity to Trelagliptin, Vildagliptin or any of the ingredients of the formulation.
2. History of acute or chronic liver disease, and SGOT or SGPT > 2.5 times of reference range or total bilirubin > 1.5 times of reference range during the screening period.
3. Renal insufficiency, with eGFR <60 ml/min/1.73 m2 or serum creatinine above 1.5 times of reference range at screening visit.
4. Acute complications of diabetes (including diabetic ketoacidosis, hyperosmolar nonketotic diabetic coma, lactic acidosis and hypoglycemia coma), or severe chronic complications (proliferative diabetic retinopathy, diabetic nephropathy)
5. Active heart disease (including acute myocardial infarction, unstable angina), moderate to severe congestive heart failure
6. History of epilepsy, mental illness, major depression, or previous abnormal thyroid function and still being treated, or those with organ transplants, severe chronic lung disease, and other serious heart disease, cerebrovascular disease, blood disease.
7. Female patients who are pregnant, lactating or not following adequate contraceptive measures.
8. Patients otherwise judged to be inappropriate for inclusion in the study by the investigator.
9. Patients with known history of pancreatitis.
Method of Generating Random Sequence
Computer generated randomization
Method of Concealment
Not Applicable
Blinding/Masking
Not Applicable
Primary Outcome
Outcome
TimePoints
Mean change in glycosylated haemoglobin (HbA1c) levels.
Baseline and end of week 16
Secondary Outcome
Outcome
TimePoints
Mean change in fasting blood glucose
Baseline and end of week 6, 12, 16
Mean change in 2-hours postprandial glucose
Baseline and end of week 6, 12, 16
Mean change in fasting insulin
Baseline and end of week 16
Mean change in fasting glucagon level
Baseline and end of week 16
Mean change in C-peptide level
Baseline and end of week 16
Mean change in GLP-1 levels
Baseline and end of week 16
Number of patients reporting incidences of adverse events
Entire study period
Target Sample Size
Total Sample Size="240" Sample Size from India="240" Final Enrollment numbers achieved (Total)= "0" Final Enrollment numbers achieved (India)="240"
Individual Participant Data (IPD) Sharing Statement
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
Response - NO
Brief Summary
Trelagliptin is an oral long-acting dipeptidyl peptidaseâ€4 (DPPâ€4) inhibitor with onceâ€weekly dosing in type 2 Diabetes Mellitus (T2DM).This study is designed to evaluate the efficacy and safety of Trelagliptin 100 mg tablets with once-weekly dosing in Indian T2DM patients. The patients will be enrolled based on the inclusion and exclusion criteria. The eligible patients will be randomized in a 1:1 ratio to receive Trelagliptin 100 mg tablet once in a week or Vildagliptin 50 mg tablet twice daily. All patients will receive the study drugs as per randomization for the duration of 16 weeks. The non-inferiority of Trelagliptin 100 mg tablets will be evaluated with Vildagliptin 50 mg tablets.