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CTRI Number  CTRI/2024/07/070821 [Registered on: 18/07/2024] Trial Registered Prospectively
Last Modified On: 16/07/2024
Post Graduate Thesis  No 
Type of Trial  Interventional 
Type of Study   Drug 
Study Design  Other 
Public Title of Study   A Real-World Study in India to Comparison of Vildagliptin Twice Daily Vs Vildagliptin Once Daily Sitagliptin Once Daily and Linagliptin Once Daily Therapy using Continuous Glucose Monitoring in Type 2 Diabetes Mellitus Patients Uncontrolled on Metformin 
Scientific Title of Study   Comparison of Vildagliptin Twice Daily Vs. Vildagliptin Once Daily, Sitagliptin Once Daily and Linagliptin Once Daily Therapy using Continuous Glucose Monitoring in Type 2 Diabetes Mellitus Patients Uncontrolled on Metformin : A Real-World Study in India  
Trial Acronym  N/A 
Secondary IDs if Any  
Secondary ID  Identifier 
NIL  NIL 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  Dr Supratik Bhattacharyya 
Designation  Endocrinologist 
Affiliation  SKN Diabetes and Endocrine Clinic 
Address  SKN Diabetes and Endocrine Clinic Room no. 5 Endocrinologist department Naihati 18 A George Road Naihati

Kolkata
WEST BENGAL
743165
India 
Phone  9830585954  
Fax    
Email  dr_supratik@yahoo.co.uk  
 
Details of Contact Person
Scientific Query  
Name  Dr Supratik Bhattacharyya 
Designation  Endocrinologist 
Affiliation  SKN Diabetes and Endocrine Clinic 
Address  SKN Diabetes and Endocrine Clinic room no.5 endocrinologist department Naihati 18 A George Road Naihati

Kolkata
WEST BENGAL
743165
India 
Phone  9830585954  
Fax    
Email  dr_supratik@yahoo.co.uk  
 
Details of Contact Person
Public Query  
Name  Dr Rishikesh Shewale 
Designation  MD Lead Medical Affairs Chronic Cluster 
Affiliation  Emcure Pharmaceutical Ltd 
Address  OBEROI GARDEN ESTATES Yadav Nagar room no.6 Chandivali Powai Mumbai Maharashtra 400072

Mumbai
MAHARASHTRA
400072
India 
Phone  9769071456  
Fax    
Email  rishikesh.shewale@emcure.com  
 
Source of Monetary or Material Support  
Emcure Pharmaceutical Ltd OBEROI GARDEN ESTATES Yadav Nagar Chandivali, Powai Mumbai Maharashtra 400072 
 
Primary Sponsor  
Name  Emcure Pharmaceutical Ltd 
Address  OBEROI GARDEN ESTATES Yadav Nagar Chandivali, Powai Mumbai Maharashtra 400072 
Type of Sponsor  Pharmaceutical industry-Indian 
 
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 
Dr Supratik Bhattacharyya  SKN Diabetes and Endocrine Clinic  Room no. 5 endocrinologist department 18A George Road Naihati pincode 743165
Kolkata
WEST BENGAL 		 9830585954

dr_supratik@yahoo.co.uk 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
Hurip Independent Bioethics Committee  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  (1) ICD-10 Condition: E112||Type 2 diabetes mellitus with kidney complications,  
 
Intervention / Comparator Agent  
Type  Name  Details 
Intervention  Group 1-Vildagliptin 50 MG + Metformin  Route of administration- Oral Dosage form- Tablet Frequency- twice daily Study Duration- 14 days 
Intervention  Group 2-Vildagliptin 100 MG + Metformin  Route of administration- Oral Dosage form- Tablet Frequency- Once daily Study Duration- 14 days 
Intervention  Group 3-Sitagliptin 100 MG + Metformin  Route of administration- Oral Dosage form- Tablet Frequency- Once daily Study Duration- 14 days 
Intervention  Group 4-Linagliptin 5MG + Metformin  Route of administration- Oral Dosage form- Tablet Frequency- Once daily Study Duration- 14 days 
 
Inclusion Criteria  
Age From  18.00 Year(s)
Age To  65.00 Year(s)
Gender  Both 
Details  Adult patients either gender greater than 18 to less than 65 years of age with T2DM Uncontrolled on Metformin Therapy maximum tolerated daily dose of at least 1500 mg

Patients who are having HbA1c greater than 7.5 percent.

Patients who are willing and able to give informed consent. 
 
ExclusionCriteria 
Details  Patients below 18 years of age of either gender

Patients who are Prediabetic

Patients who had taken insulin and antidiabetic agents other than metformin in last 3 months

Patients with Type 1 diabetes

Female patients who were pregnant or breast feeding

Presence of any other clinically significant disease or laboratory findings that in the Investigators opinion may affect the study outcomes or continued participation of patient in the study

Participation in another study concurrently or within 4 weeks prior to initiation of treatment 
 
Method of Generating Random Sequence   Not Applicable 
Method of Concealment   Not Applicable 
Blinding/Masking   Not Applicable 
Primary Outcome  
Outcome  TimePoints 
Baseline Reading & Final Reading of 48 hrs. CGM will be noted & compared.

Assessment of Average Daily Glucose (ADG) at baseline and 14 days.

Assessment of Time in target at baseline and 14 days.

Assessment of time below target at baseline and 14 days.

Assessment of time above target at baseline and 14 days. 		 Baseline Reading, 48 hrs.and 14 days of treatment period.  
 
Secondary Outcome  
Outcome  TimePoints 
Adverse events (AE) or serious adverse events (SAE), either spontaneously reported by the patient, or noticed by the investigator will be recorded during the study.   at 13 days and 14 days 
 
Target Sample Size   Total Sample Size="40"
Sample Size from India="40" 
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)   30/07/2024 
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="0"
Months="0"
Days="15" 
Recruitment Status of Trial (Global)   Not Applicable 
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 - NO
Brief Summary  

Study Title 

Comparison of Vildagliptin Twice Daily Vs. Vildagliptin Once Daily, Sitagliptin Once Daily and Linagliptin Once Daily Therapy using Continuous Glucose Monitoring in Type 2 Diabetes Mellitus Patients Uncontrolled  on Metformin : A Real-World Study in India. 

Background 

Several epidemiological studies have found Type 2 Diabetes Mellitus (T2DM) prevalence in India to be 5–17%, which accounts for 90%–95% of diabetes cases (1). The American diabetic association (ADA) and American college of endocrinology recommend Metformin, an oral-hypoglycemic drug of class biguanide, as the first-line treatment for T2DM (2). ADA suggests metformin monotherapy followed by sulfonylureas, thiazolidinedione, dipeptidyl peptidase-4 (DPP-4) inhibitor, sodium-glucose cotransporter-2 inhibitor (SGLT2-i), GLP-1 receptor agonist, and insulin alone or in combination (3).  

Vildagliptin, an oral DPP-4i, inhibits DPP-4’s catalytic site and protects glucagon-like peptide-1 and islet function. Metformin (biguanide) decreases dietary glucose absorption and liver synthesis. (4). T2DM is a multifactorial disease and requires combination therapy to manage hyperglycemia. Biguanides, and DPP4i’s complementary modes of action has synergistic effects and improves glycaemic control (5). 

When this combination and add on therapies for diabetic control are used, the clinicians should monitor the patient continuously to evaluate the changes in glucose level and improvement. This idea led to the concept of continuous glucose monitoring which helps in informing, educating, motivating, and alerting people with diabetes. (6) 

Continuous glucose monitoring (CGM) began in 2000 in clinical practice and evolved during the time with many advances. CGM benefits the patient by continuously measuring the interstitial glucose over time and detecting glucose variations, hypoglycaemic events, and TIR. Real-time CGM has shown to be associated with reductions in HbA1c in individuals with type 2 diabetes, without increasing the frequency of hypoglycaemia. (7) 

A real-world evidence is not available on Indian population, evaluating CGM status in patients receiving Metformin in combination with Vildagliptin and its comparision with other gliptins like Sitagliptin and Linagliptin. Our study objective is to compare CGM profiles of Vildagliptin Twice Daily, Vildagliptin Once Daily, Sitagliptin and Linagliptin, in Type 2 Diabetes Mellitus patients Uncontrolled on Metformin therapy. 

Study Objective 

To compare continuous glucose monitoring (CGM) profiles of Vildagliptin Twice Daily, Vildagliptin Once Daily, Sitagliptin and Linagliptin, in Type 2 Diabetes Mellitus patients Uncontrolled on Metformin therapy. 

Study Design 

Four-arm, Single-centre, Real-world study  

Group 1: Vildagliptin 50mg BD + Metformin (n=10) 

Group 2: Vildagliptin 100 mg SR OD + Metformin (n=10) 

Group 3: Sitagliptin 100 mg OD + Metformin (n=10) 

Group 4: Linagliptin 5mg OD + Metformin (n=10) 

Study Sites 

One site in India will be involved in the study. 

Sample size 

Approximately 40 patients who qualify based on study selection criteria will be enrolled in the study. 

Study population  

Patients with Type 2 Diabetes Mellitus who are uncontrolled  on Metformin 

Study Patients 

Inclusion Criteria: 

Subjects meeting with following criteria will be included in the study: 

  • Adult patients, either gender, ≥18 to ≤65 years of age with T2DM Uncontrolled on Metformin Therapy (maximum tolerated daily dose of at least 1500 mg). 

  • Patients who are having HbA1c >7.5%. 

  • Patients who are willing and able to give informed consent. 

Exclusion Criteria: 

Subjects meeting with following criteria will be excluded from the study: 

  • Patients below 18 years of age of either gender. 

  • Patients who are Prediabetic 

  • Patients who had taken insulin and antidiabetic agents other than metformin in last 3 months 

  • Patients with Type 1 diabetes   

  • Female patients who were pregnant or breast feeding 

  • Presence of any other clinically significant disease or laboratory findings that in the Investigator’s opinion may affect the study outcomes or continued participation of patient in the study. 

  • Participation in another study concurrently or within 4 weeks prior to initiation of treatment. 

Study Medications 

Vildagliptin Twice Daily, Vildagliptin Once Daily, Sitagliptin Once Daily and Linagliptin Once Daily in combination with Metformin. 

Study Follow-up Duration 

Once enrolled into the study the patient will be instructed to return to the study investigators clinic to evaluate the study outcomes after a period of 13 days and 14 days. The duration of the study for the participants is 14 Days ± 1 Day. 

Study Timelines 

Documentation & Submission – May 2024 

Approvals & Setup – Jun 2024 

Patient accrual – Sep 2024 

Data collection & analysis – October 2024 

Study report – November 2024 

Efficacy endpoints 

  • Baseline Reading & Final Reading of 48 hrs. CGM will be noted & compared (using freestyle Libre Pro. Device) at first 2 days (Metformin therapy) & last 2 days (Metformin + Gliptin therapy) of study period. 

  • Assessment of Average Daily Glucose (ADG) during the monitoring period while on study treatments at baseline and during 14 days of treatment period. 

  • Assessment of Time-in-Target (TIT) during the monitoring period while on study treatments at baseline and during 14 days of treatment period. 

  • Assessment of Time below Target (TBT) during the monitoring period while on study treatments at baseline and during 14 days of treatment period. 

  • Assessment of Time above Target (TAT) during the monitoring period while on study treatments at baseline and during 14 days of treatment period. 

Safety endpoints 

  • Adverse events (AE) or serious adverse events (SAE), either spontaneously reported by the patient, or noticed by the investigator will be recorded during the study. 

Study Methodology 

  • Patients uncontrolled on Metformin who fulfil pre-defined inclusion/exclusion criteria will be eligible to participate in the study.  

  • Baseline Reading (48 hrs CGM) will be noted Using freestyle Libre Pro. Device) for first 2 days in patients on Metformin therapy. 

  • Either of the Gliptin therapy mentioned below will be added to the ongoing Metformin therapy and continued till the end of study. 

Group 1: Vildagliptin 50mg BD + Metformin (n=10) 

Group 2: Vildagliptin 100 mg SR OD + Metformin (n=10) 

Group 3: Sitagliptin 100 mg OD + Metformin (n=10) 

Group 4: Linagliptin 5mg OD + Metformin (n=10) 

  • Final Reading (48 hrs CGM) will be noted Using freestyle Libre Pro. Device) on last 2 days (Day 13 and 14) in patients on Metformin Plus Gliptin therapy from respective groups. 

  • The average values of the first 2 days will be designated as the baseline reading.   

  • The average values of the last 2 days will be designated as the final reading.  

Following Efficacy and Safety Endpoints will be assessed. 

 

Efficacy Endpoints 

  • Average Daily Glucose (ADG) 

  • Time in Target (TIT) 

  • Time Below Target (TBT) 

  • Time Above Target (TAT) 

Safety Endpoints: Patient will be monitored for any adverse event during study period. 

Statistical Analysis 

The data collected will be pooled in a Microsoft Excel spreadsheet and then transferred for statistical calculations to SPSS. 

The primary endpoint will be calculated using any relevant statistical test. A p-value of <0.05 will be considered statistically significant. 

Statistical Methodology 

Demographic Characteristics 

Continuous data like age, weight etc. will be summarized with n, mean, SD and range. Categorical data like sex etc. will be depicted with count (%). 

Efficacy Analysis 

Efficacy parameters such as Comparison of CGM profiles at Baseline and Final Visit, and Assessments of ADG, TIT, TBT, and TAT will be summarized with n, mean, SD, range and change from baseline to Final will be evaluated.  

Safety Analysis 

Incidence of adverse events will be summarized with count (%). Other safety measures such as physical examination and vital signs will be summarized using descriptive statistics and change from baseline, if applicable. 

 
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