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CTRI Number  CTRI/2024/10/074542 [Registered on: 01/10/2024] Trial Registered Prospectively
Last Modified On: 17/09/2024
Post Graduate Thesis  Yes 
Type of Trial  Interventional 
Type of Study   Drug 
Study Design  Randomized, Parallel Group Trial 
Public Title of Study   Comparison of Vildagliptin plus Metformin versus Vildagliptin plus Metformin plus Zinc in controlling blood sugar levels among type 2 diabetes mellitus patients. 
Scientific Title of Study   A comparative evaluation of safety and efficacy of Vildagliptin with Metformin versus Vildagliptin with Metformin along with Zinc as an adjuvant in newly diagnosed Type 2 Diabetes Mellitus patients in a tertiary care Hospital, Kanpur (U.P) 
Trial Acronym  NIL 
Secondary IDs if Any  
Secondary ID  Identifier 
NIL  NIL 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  ANJALY MARY VARGHESE 
Designation  PhD Student 
Affiliation  Rama Medical College Hospital and Research Centre 
Address  Department of Pharmacology, Rama Medical College Hospital and Research Centre, Mandhana, Kanpur,

Kanpur Nagar
UTTAR PRADESH
209217
India 
Phone  08978373630  
Fax    
Email  niya4niky@gmail.com  
 
Details of Contact Person
Scientific Query  
Name  DR NILAM NIGAM 
Designation  Professor and Head of Department 
Affiliation  Rama Medical College Hospital and Research Centre 
Address  Department of Pharmacology, Rama Medical College Hospital and Research Centre, Mandhana, Kanpur

Kanpur Nagar
UTTAR PRADESH
209217
India 
Phone  09140190476  
Fax    
Email  drnilamnigam@gmail.com  
 
Details of Contact Person
Public Query  
Name  ANJALY MARY VARGHESE 
Designation  PhD Student 
Affiliation  Rama Medical College Hospital and Research Centre 
Address  Department of Pharmacology, Rama Medical College Hospital and Research Centre, Mandhana, Kanpur

Kanpur Nagar
UTTAR PRADESH
209217
India 
Phone  08978373630  
Fax    
Email  niya4niky@gmail.com  
 
Source of Monetary or Material Support  
Rama Medical College Hospital and Research Centre, Mandhana, Kanpur Nagar, Uttar Pradesh-209217, India 
 
Primary Sponsor  
Name  ANJALY MARY VARGHESE  
Address  PhD Student Department of Pharmacology, Department of Pharmacology, Rama Medical College Hospital and Research Centre, Mandhana, Kanpur Nagar, Uttar Pradesh-209217, India  
Type of Sponsor  Other [Self] 
 
Details of Secondary Sponsor  
Name  Address 
NIL  NIL 
 
Countries of Recruitment     India  
Sites of Study  
No of Sites = 1  
Name of Principal Investigator  Name of Site  Site Address  Phone/Fax/Email 
ANJALY MARY VARGHESE  Rama Medical College Hospital and Research Centre  Room no: 02158, Department of Pharmacology, Rama Medical College Hospital and Research Centre, Mandhana, Kanpur Nagar, Uttar Pradesh-209217, India
Kanpur Nagar
UTTAR PRADESH 		 8978373630

niya4niky@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
Rama Medical College Hospital and Research Centre  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  
Type  Name  Details 
Comparator Agent  Metformin and Vildagliptin  Metformin 500 mg and Vildagliptin 50 mg- BD, orally For 36 weeks 
Intervention  Metformin, Vildagliptin and Zinc  Metformin 500 mg and Vildagliptin 50 mg- BD With Zinc 25 mg OD, orally for 36 weeks 
 
Inclusion Criteria  
Age From  18.00 Year(s)
Age To  60.00 Year(s)
Gender  Both 
Details  Patients who are newly diagnosed as suffering from Type 2 Diabetes mellitus not on any oral hypoglycemic agent. Patients with HbA1c between (7.0-9.5%), fasting glucose levels of above 126mg per dl or random blood glucose above or equal to 200mg/dl. Patients willing to participate in the trial, ready to abide by trial procedures and willing to give written informed consent. 
 
ExclusionCriteria 
Details  Patients with active liver (more than 3 fold rise in ALT/AST) or kidney diseases, malignancies, neurological diseases, endocrine disorders, autoimmune diseases, and cardiovascular diseases. Uncontrolled hypertension (with systolic blood pressure: ≥180 mm Hg/diastolic blood pressure: ≥100 mm Hg). Smokers/ Alcoholics. Pregnant / lactating women. Acute pancreatitis, cystic fibrosis, hemochromatosis. Patient having known hypersensitivity to the study drugs.
 
 
Method of Generating Random Sequence   Computer generated randomization 
Method of Concealment   Centralized 
Blinding/Masking   Open Label 
Primary Outcome  
Outcome  TimePoints 
Target FBS, PPBS and HbA1c  12, 24, 36 weeks 
 
Secondary Outcome  
Outcome  TimePoints 
Adverse drug events
Patient compliance 		 12, 24, 36 weeks 
 
Target Sample Size   Total Sample Size="410"
Sample Size from India="410" 
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 4 
Date of First Enrollment (India)   03/10/2024 
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 
Estimated Duration of Trial   Years="1"
Months="0"
Days="0" 
Recruitment Status of Trial (Global)   Not Yet Recruiting 
Recruitment Status of Trial (India)  Not Yet Recruiting 
Publication Details   N/A 
Individual Participant Data (IPD) Sharing Statement

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

Response - YES
  1. What data in particular will be shared?
    Response - Individual participant data that underlie the results reported in this article, after de-identification (text, tables, figures, and appendices).

  2. What additional supporting information will be shared?
    Response -  Study Protocol
    Response -  Statistical Analysis Plan
    Response - Informed Consent Form

  3. Who will be able to view these files?
    Response - Anyone

  4. For what types of analyses will this data be available?
    Response - Any purpose.

  5. By what mechanism will data be made available?
    Response - Proposals should be directed to [niya4niky@gmail.com].

  6. For how long will this data be available start date provided 03-12-2025 and end date provided 03-12-2028?
    Response - Beginning 9 months and ending 36 months following article publication.

  7. Any URL or additional information regarding plan/policy for sharing IPD? 
    Additional Information - NIL
Brief Summary   This study is a randomized, open labeled, parallel group, single- centre trial comparing the efficacy and safety of metformin 1000 mg / Vildagliptin 100 mg daily and metformin 1000 mg / Vildagliptin 100 mg/ Zinc 25 mg daily for 36 weeks in 410 patients with newly diagnosed type 2 diabetes that will be conducted in a tertiary care hospital, Kanpur, India. The primary outcome measures will be achieving target blood sugar and glycosylated hemoglobin A1C (<7) during 12, 24, 36 weeks of study period. The secondary outcomes will be evaluation of safety of the treatment at 12, 24, 36 weeks and patient compliance. 
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