CTRI/2025/08/093181 [Registered on: 18/08/2025] Trial Registered Prospectively
Last Modified On:
18/08/2025
Post Graduate Thesis
No
Type of Trial
Observational
Type of Study
Multicentri Non-Interventional RWE
Study Design
Other
Public Title of Study
INITIATE-India Study
Scientific Title of Study
A Clinical Evaluation of Early Initiation of Oral Semaglutide as a Monotherapy or in Combination with Other Oral-Antidiabetic drugs in Indian Adults with Type 2 Diabetes: A Prospective Multicentric Non-interventional Study.
Trial Acronym
INITIATE- India
Secondary IDs if Any
Secondary ID
Identifier
NIL
NIL
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
Name
Dr Krishna G Seshadri
Designation
Senior Consultant Endocrinology and Diabetes
Affiliation
Apollo Speciality Hospitals
Address
Department of Endocrinology,
Division of Medical Education,
Apollo Hospital, Chennai,
Room No. 21, Greams Lane, Greams Lane off Greams Road,
Chennai – 600006,
Tamil Nadu, India
Chennai TAMIL NADU 600095 India
Phone
9940068170
Fax
Email
krishnagseshadri@gmail.com
Details of Contact Person Scientific Query
Name
Dr Krishna G Seshadri
Designation
Senior Consultant Endocrinology and Diabetes
Affiliation
Apollo Speciality Hospitals
Address
Department of Endocrinology,
Division of Medical Education,
Apollo Hospital, Chennai,
Room No. 21, Greams Lane, Greams Lane off Greams Road,
Chennai – 600006,
Tamil Nadu, India
Chennai TAMIL NADU 600095 India
Phone
9940068170
Fax
Email
krishnagseshadri@gmail.com
Details of Contact Person Public Query
Name
Dr Krishna G Seshadri
Designation
Senior Consultant Endocrinology and Diabetes
Affiliation
Apollo Speciality Hospitals
Address
Department of Endocrinology,
Division of Medical Education,
Apollo Hospital, Chennai,
Room No. 21, Greams Lane, Greams Lane off Greams Road,
Chennai – 600006,
Tamil Nadu, India
Chennai TAMIL NADU 600095 India
Phone
9940068170
Fax
Email
krishnagseshadri@gmail.com
Source of Monetary or Material Support
Nil
Primary Sponsor
Name
Academic Trial
Address
Nil
Type of Sponsor
Private hospital/clinic
Details of Secondary Sponsor
Name
Address
NIL
NIL
Countries of Recruitment
India
Sites of Study
No of Sites = 21
Name of Principal
Investigator
Name of Site
Site Address
Phone/Fax/Email
Dr J Selvakumar
Dr. Mohans Diabetes Specialities Centre
Dr. Mohans Diabetes Specialities Centre No 2, Kalidasan Street, Tambaram East, Chennai - 600059 Chennai TAMIL NADU
9444232919
selvasha71@yahoo.co.in
Dr Krishna Sheshadri
Apollo Speciality Hospitals Vanagaram
Apollo Speciality Hospitals Vanagaram, No.64, Vanagaram To Ambattur Main Road, Chennai, Tamil Nadu 600095 Chennai TAMIL NADU
99400 68170
krishnagseshadri@gmail.com
Dr Vishnu Radhakrishnan
CataLife Health Care
1st Floor, EKB Towers, Doctors Colony, Karuvambram, Manjeri Kerala - 676121 Malappuram KERALA
9400593905
vishnumavoor1@gmail.com
Dr G Krishna Shankar
Dr G Krishna Shankar Clinic
1435, Sakthy Trade Centre, Opp. Ganapathy Annapoorna, Bharathy Nagar Bus Stop, Ganapathy, Coimbatore - 641006 Coimbatore TAMIL NADU
(1) ICD-10 Condition: E119||Type 2 diabetes mellitus without complications,
Intervention / Comparator Agent
Type
Name
Details
Intervention
Nil
Nil
Inclusion Criteria
Age From
18.00 Year(s)
Age To
90.00 Year(s)
Gender
Both
Details
1. Age more than or equal to 18 years (male and female)
2. Diagnosed with T2D within the last one year
HbA1c level: 7.0 percentage to 9.5 percentage (both inclusive)
3. Drug-naive or on oral anti-diabetic medications within the last one year
4. Drug naive for GLP 1 agonists
ExclusionCriteria
Details
1. Type 1 Diabetes Mellitus (T1DM)
2. Gestational Diabetes Mellitus (GDM)
3. Maturity Onset Diabetes of the Young (MODY)
4. Current ongoing steroid therapy
5. History of pancreatitis
6. Known Cup-to-disc ratio less than 0.2
7. History of Proliferative retinopathy or maculopathy requiring acute treatment (verified within
90 days prior to screening)
8. Osmotic symptoms
9. Personal or family history of medullary thyroid carcinoma (MTC) or MEN 2
10. eGFR less than 15 mL per min per 1.73 m² within the last one year
11. History of heart failure (New York Heart Association class IV)
12. History of Gallstones
13. History of malignant neoplasms within the last 5 years
14. Pregnant or planning pregnancy up to 9 months after enrollment
15. Already on insulin therapy or requires initiation of insulin therapy
16. Known hypersensitivity to OS or OADs or other GLP-1 analogues
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
week 26.
26 weeks.
Secondary Outcome
Outcome
TimePoints
Change in Fasting Plasma Glucose-
FPG (mg/dL),Post Prandial Plasma Glucose- PPPG (mg/dL),
Body Mass Index- BMI (kg/m2), Waist circumference (cms),
body weight (kgs), SBP (mm of Hg), DBP (mm of Hg) Urine
albumin-to-creatinine ratio -UACR, and lipid profile(TC
(mg/dL), LDL-C (mg/dL), HDL-C (mg/dL), TG (mg/dL) -from baseline to week 26
26 weeks
The study will evaluate the percentage of patients achieving
more than 1% HbA1c reduction with more than 3% or more than 5% weight loss, both with
and without severe hypoglycemia, at the end of the study.
at the end of the study
The proportion of patients discontinuing OS
due to Gastrointestinal (GI) related AEs, treatment emergent
adverse events (TEAEs) and the number of self-reported severe
hypoglycemic episodes.
at the end of the study
LFTs (AST (IU/L), ALT (IU/L), and
Serum bilirubin (mg/dl)) and STOP-Bang Score from baseline
to week 26.
26 weeks
Target Sample Size
Total Sample Size="518" Sample Size from India="518" 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)
01/09/2025
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="1" Months="0" 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
Type 2 diabetes (T2D) is a growing global health challenge, with India bearing a significant burden due to unique genetic, lifestyle, and socio-economic factors. Despite the availability of multiple oral antidiabetic drugs (OADs), achieving sustained glycemic control remains difficult due to side effects, patient non-adherence, and secondary OAD failure. Semaglutide, a glucagon-like peptide-1 receptor agonist (GLP-1RA), is the first such agent available in oral form. Global studies, including the PIONEER trial program, have demonstrated its efficacy in improving HbA1c and reducing weight across different stages of T2D management. This prospective, multicentric, non-interventional study aims to evaluate the real-world clinical outcomes of early initiation of oral Semaglutide as monotherapy or in combination with other OADs in Indian adults with T2D. The findings may offer valuable insights into its effectiveness, tolerability, and potential for improving T2D outcomes in the Indian population.