| 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
|
|
|
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
|
|
|
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. |