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CTRI Number  CTRI/2025/04/085464 [Registered on: 23/04/2025] Trial Registered Prospectively
Last Modified On: 09/04/2025
Post Graduate Thesis  Yes 
Type of Trial  Observational 
Type of Study   Cohort Study 
Study Design  Single Arm Study 
Public Title of Study   Studying the Safety and Benefits of Oral Semaglutide for People with Diabetes and Obesity. 
Scientific Title of Study   Safety and Efficacy of Oral Semaglutide in Patients with Type 2 Diabetes and Obesity: An Observational Study at a Tertiary Care Hospital.  
Trial Acronym  nil 
Secondary IDs if Any  
Secondary ID  Identifier 
NIL  NIL 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  Vengatesh S 
Designation  M. Pharmacy-Pharmacy Practice 
Affiliation  Sri Ramachandra Institute of Higher Education and Research. 
Address  Department of Pharmacy Practice, Faculty of Pharmacy, Sri Ramachandra Institute of Higher Education and Research, Porur, Chennai.

Chennai
TAMIL NADU
600116
India 
Phone  9003808906  
Fax    
Email  p1123008@sriher.edu.in  
 
Details of Contact Person
Scientific Query
 
Name  Dr A Mohathasim Billah 
Designation  Professor 
Affiliation  Sri Ramachandra Institute of Higher Education and Research 
Address  Department of Pharmacy Practice, Faculty of Pharmacy, Sri Ramachandra Institute of Higher Education and Research, Porur, Chennai.

Chennai
TAMIL NADU
600116
India 
Phone  9488588735  
Fax    
Email  amb@sriramachandra.edu.in  
 
Details of Contact Person
Public Query
 
Name  Dr Adlyne Reena Asirvatham 
Designation  Professor and Consultant 
Affiliation  Sri Ramachandra Institute Of Higher Education and Research 
Address  Department Of Endocrinology, Sri Ramachandra Institute Of Higher Education and Research, Porur, Chennai.

Chennai
TAMIL NADU
600116
India 
Phone  9843051977  
Fax    
Email  adlynereena@yahoo.co.in  
 
Source of Monetary or Material Support  
Sri Ramachandra Institute Of Higher Education and Research, Deemed to be University,Porur,Chennai-600116 
 
Primary Sponsor  
Name  Sri Ramachandra Institute Of Higher Education and Research 
Address  Sri Ramachandra Institute Of Higher Education and Research, Deemed to be University,Porur,Chennai-600116 
Type of Sponsor  Research institution and hospital 
 
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 A Mohathasim Billah  Sri Ramachandra Hospital  Sri Ramachandra Medical Centre, 1st floor, A1 Out Patient, Department Of Endocrinology.
Chennai
TAMIL NADU 
9488588735

amb@sriramachandra.edu.in 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
Ethics Committee For Student Projects  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  (1) ICD-10 Condition: E116||Type 2 diabetes mellitus with other specified complications,  
 
Intervention / Comparator Agent  
Type  Name  Details 
Intervention  NA  NA 
 
Inclusion Criteria  
Age From  18.00 Year(s)
Age To  70.00 Year(s)
Gender  Both 
Details  1 Adults more than 18 years diagnosed with Type 2 diabetes with HbA1C 7 percent to 10 percent.

2 BMI more than 27 kg per m2 indicative of obesity.
 
 
ExclusionCriteria 
Details  1 Type 1 diabetes or other severe comorbidities such as renal or liver disease.

2 Pregnant or breastfeeding women.

3 Patients currently on other GLP 1 receptor agonists insulin or weight loss medications. 
 
Method of Generating Random Sequence   Not Applicable 
Method of Concealment   Not Applicable 
Blinding/Masking   Not Applicable 
Primary Outcome  
Outcome  TimePoints 
Change in HbA1c (%) from baseline to the end of the study (to assess glycemic control).

Change in body weight (kg or % reduction) from baseline to the end of the study (to evaluate weight loss).
 
1 Month 
 
Secondary Outcome  
Outcome  TimePoints 
Safety & Tolerability:
Incidence of adverse events & Serious Adverse Events.

Gastrointestinal side effects such as nausea, vomiting, diarrhea.

Hypoglycemia events.
 
1 Month 
 
Target Sample Size   Total Sample Size="45"
Sample Size from India="45" 
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)   07/05/2025 
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="6"
Days="0" 
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  

 

Aim:

The aim of the study is to evaluate the safety and efficacy of oral semaglutide in improving glycemic control and promoting weight reducton In  patientse with type 2 diabetes and obesity.

Objectives:

Main Objective: 

           To assess the efficacy of oral semaglutide in reducing HbA1c levels in South Indian patients with type 2 diabetes and obesity treated at a tertiary care hospital.

          Secondary Objectives:

1.     To assess the degree of weight reduction achieved with treatment.

2.     To monitor and document any adverse events associated with oral semaglutide use in South Indian patients

3.     Record the incidence and types of adverse effects in this population.

4.     To determine patient adherence and satisfaction with oral semaglutide therapy over the study period..

STUDY DESIGN: Observational Prospective Cohort Study

           SAMPLE SIZE: The sample size for safety and efficacy of oral semaglutide  was n=45.

EXPECTED OUTCOME OF THE STUDY:

 

The study is expected to demonstrate a significant reduction in HbA1c levels, likely around 1%, showing effective glycemic control in South Indian patients with type 2 diabetes and obesity. Clinically meaningful weight loss (5-10% of body weight) is also anticipated, alongside improvements in fasting blood glucose and cardiovascular risk factors such as blood pressure and lipid profiles.

 

The safety profile should be favorable, with gastrointestinal side effects like nausea and vomiting being the most common, and a low incidence of serious adverse events like hypoglycemia or pancreatitis. Subgroup analyses may reveal differences in efficacy based on age, gender, or baseline BMI.

 

The study will likely support oral semaglutide as an effective and safe treatment option, contributing to better management of diabetes and obesity in the South Indian population. These findings could guide clinical protocols in tertiary care hospitals.

 
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