| CTRI Number |
CTRI/2020/09/027971 [Registered on: 22/09/2020] Trial Registered Prospectively |
| Last Modified On: |
23/09/2026 |
| Post Graduate Thesis |
No |
| Type of Trial |
Interventional |
|
Type of Study
|
Drug |
| Study Design |
Randomized, Parallel Group, Placebo Controlled Trial |
|
Public Title of Study
|
A research study to compare a new medicince oral semaglutide with dummy medicine in cildren and teenagers with Type 2 diabetes |
|
Scientific Title of Study
|
Efficacy and safety of oral semaglutide versus placebo both in combination with metformin and/or basal insulin in children and adolescents with type 2 diabetes |
| Trial Acronym |
|
Secondary IDs if Any
Modification(s)
|
| Secondary ID |
Identifier |
| 2023-506923-27 |
EudraCT |
| U1111-1218-1527 |
UTN |
| Version 9.0 Dated 21 May 2025 |
Protocol Number |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
|
| Designation |
|
| Affiliation |
|
| Address |
|
| Phone |
|
| Fax |
|
| Email |
|
|
Details of Contact Person
Scientific Query
Modification(s)
|
| Name |
Vijay Parthasarathy |
| Designation |
Director- CDC India |
| Affiliation |
Novo Nordisk India private Ltd |
| Address |
Novo Nordisk India Private Limited,
Nxt Tower - 2, Floor 1 & 2
Embassy Manyata Business Park,
Nagavara Village, Kasaba Hobli,
Bangalore - 560045. India
Bangalore
KARNATAKA
560045
India |
| Phone |
8030713355 |
| Fax |
|
| Email |
vjyp@novonordisk.com |
|
Details of Contact Person
Public Query
Modification(s)
|
| Name |
Vijay Parthasarathy |
| Designation |
Director- CDC India |
| Affiliation |
Novo Nordisk India private Ltd |
| Address |
Novo Nordisk India private Ltd
Nxt Tower - 2, Floor 1 & 2
Embassy Manyata Business Park,
Nagavara Village, Kasaba Hobli,
Bangalore - 560045. India
Bangalore
KARNATAKA
560045
India |
| Phone |
8030713355 |
| Fax |
|
| Email |
vjyp@novonordisk.com |
|
Source of Monetary or Material Support
Modification(s)
|
| Novo Nordisk A/S
Novo Allé, 2880 Bagsvaerd Denmark
Pharmaceutical industry- Global
|
|
Primary Sponsor
Modification(s)
|
| Name |
Novo Nordisk India private Ltd |
| Address |
Nxt Tower - 2, Floor 1 & 2
Embassy Manyata Business Park,
Nagavara Village, Kasaba Hobli,
Bangalore - 560045. India |
| Type of Sponsor |
Pharmaceutical industry-Global |
|
|
Details of Secondary Sponsor
|
|
Countries of Recruitment
Modification(s)
|
Australia
Austria
Belgium
Czech Republic
Greece
India
Israel
Lebanon
Malaysia
Morocco
Netherlands
New Zealand
Portugal
Russian Federation
Ukraine
United Kingdom
United States of America
Mexico
Taiwan
Romania |
Sites of Study
Modification(s)
|
| No of Sites = 8 |
| Name of Principal
Investigator |
Name of Site |
Site Address |
Phone/Fax/Email |
| Dr Rajesh Khadgawat |
All India Institute of Medical Sciences (AIIMS) |
Room no 303, Biotechnology block,Dept of Endocrinology
New Delhi
DELHI |
9891418190
rajeshkhadgawat@hotmail.com |
| Dr Kongara Srikanth |
Endolife Speciality hospitals |
Room of Dr. K. Srikanth (Sr. Consultant), Ground Floor, Endolife Speciality hospitals, Old club road
Kothapet
Guntur
ANDHRA PRADESH |
9849945577
srikanthendo@gmail.com |
| Dr Sailesh Lodha |
Eternal Hospital |
Room No.23,OPD 1,Eternal Hospital, Near Jawahar circle, Chainpura
Malviya Nagar
New Delhi
DELHI |
9829614455
saileshlodha@gmail.com |
| Dr Sharvil Gadve |
Excel Endocrine Centre |
Excel Endocrine Centre, CTS 1556, plot no. 52, 2nd Ln, opp. Hotel Castle, Poorvarang, Mahalaxminagar, Rajarampuri, Kolhapur- 416008,Maharashtra
Kolhapur
MAHARASHTRA |
9552365977
excel.endocrine@gmail.com |
| Dr Subhankar Chowdhury |
IPGME&R and SSKM Hospital, |
Dept. of Endocrinology
IPGME&R and SSKM Hospital,
Ronald Ross Building, 4th Floor, Room-8
244, A. J. C. Bose Road
Kolkata
WEST BENGAL |
9831076501
subhankar.chowdhury@gmail.com |
| Dr Jothydev Kesavadev |
Jothydevs diabetes & research center |
room No 25,2nd floor , Jothydevs diabetes & research center, Mudavanmugal.
Thiruvananthapuram
KERALA |
9895040055
jothydev@gmail.com |
| Dr Manoj Chadha |
P D Hinduja National Hospital |
2nd floor, Room No. 2214,P D Hinduja National Hospital,SVS Rd, Mahim West, Shivaji Park
Mumbai
MAHARASHTRA |
9821548346
mchadha59@gmail.com |
| Dr PV Rao |
Ramdev rao hospital |
Diabetes Research Center
6-3-349/17b & 31, Hindi Nagar Colony,
Behind Panjagutta Saibaba Temple,
Panjagutta, Hyderabad- 500082
Telangana India.
Hyderabad
TELANGANA |
9885051110
raopaturi@gmail.com |
|
Details of Ethics Committee
Modification(s)
|
| No of Ethics Committees= 8 |
| Name of Committee |
Approval Status |
| Excel Endocrine Center, Institutional Ethics Committee |
Approved |
| Institutional Ethics Committee of All India Institute of Medical Sciences |
Approved |
| Institutional Ethics Committee of Endolife Speciality Hospitals Pvt. Ltd |
Approved |
| Institutional Ethics Committee of Eternal Heart Care Centre & Research Institute |
Approved |
| institutional Ethics Committee of IPGME & R Research Oversight Committee |
Approved |
| Institutional Ethics Committee of Jothydev’s Diabetic Research Centre |
Approved |
| Institutional Ethics Committee of P D Hinduja Hospital and Medical Research Centre |
Approved |
| Institutional Ethics Committee of Ramdev Rao Hospital |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
| Status |
| No Objection Certificate |
|
|
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 |
Placebo |
3mg, 7mg and 14mg
Once a day (OD)
Oral. Duration of treatment is 52 weeks. |
| Intervention |
Semaglutide |
3mg, 7mg and 14mg
Once a day (OD)
Oral. Duration of treatment is 52 weeks. |
|
Inclusion Criteria
Modification(s)
|
| Age From |
10.00 Year(s) |
| Age To |
17.00 Year(s) |
| Gender |
Both |
| Details |
Informed consent from parents or legally acceptable representative and child assent from the subject obtained before any trial-related activities. Trial-related activities are any procedures that are carried out as part of the trial, including activities to determine suitability for the trial.
Male or female, aged 10 to below 18 years at the day of randomisation
HbA1c 6.5percentage-11.0percentage 47-97 mmol/mol both inclusive
Diagnosed with type 2 diabetes mellitus according to the American Diabetes Association criteria and treated with
stable metformin dose stable metformin dose is defined as at least 1000 mg daily or the maximum tolerated dose for 56 days or longer prior to screening or
stable metformin dose and a stable dose of basal insulin stable dose of basal insulin is defined as basal insulin treatment equal to or more than 30 days prior to screening, compared to the dose at screening, dose adjustments of plus or minus 25percentage are allowed or
stable dose of basal insulin |
|
| ExclusionCriteria |
| Details |
Diagnosis of type 1 diabetes
Maturity onset diabetes of the young MODY
Positive insulinoma associated-protein 2 IA-2
antibodies or anti-glutamic acid decarboxylase anti-GAD antibodies. |
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
Centralized |
|
Blinding/Masking
|
Participant, Investigator and Outcome Assessor Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
Change from baseline (week 0) to week 26 in glycosylated haemoglobin (HbA1c) (%-point and mmol/mol)
|
Week 0 to Week 26 |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
Fasting plasma glucose (FPG) (mmol/L)
|
Week 0 to Week 26
|
Body mass index (BMI) standard deviation score (SDS)
|
Week 0 to Week 26
|
"HbA1c (%-point and mmol/mol)
FPG (mmol/L)
BMI SDS "
|
at week 52
|
"Body weight (kg), Body weight (relative change, %)
Waist circumference (cm)
BMI percentile (age and gender adjusted) (%)
Systolic and diastolic blood pressure (mmHg)"
|
Week 0 to Week 26
|
|
|
Target Sample Size
|
Total Sample Size="132"
Sample Size from India="25"
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 3 |
|
Date of First Enrollment (India)
|
02/11/2020 |
| Date of Study Completion (India) |
Applicable only for Completed/Terminated trials |
| Date of First Enrollment (Global) |
02/11/2020 |
| Date of Study Completion (Global) |
Applicable only for Completed/Terminated trials |
|
Estimated Duration of Trial
|
Years="1"
Months="3"
Days="0" |
Recruitment Status of Trial (Global)
Modification(s)
|
Closed to Recruitment of Participants |
| Recruitment Status of Trial (India) |
Closed to Recruitment of Participants |
|
Publication Details
|
NIL |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
Response - NO
|
|
Brief Summary
|
PIONEER TEENS (NN9924-4437) will be conducted to confirm the efficacy and safety of oral semaglutide in the paediatric population to address the unmet need for treatment of children and adolescents 10 to <18 years of age with type 2 diabetes. This is a randomised, double-blind, placebo-controlled, parallel-group, multi-national, and multi-centre clinical trial that includes a 52-week treatment period followed by a 12-week off-trial product follow-up period. We are unable to find the country list " MACEDONIA". Hence the data has been retain in the brief summary
|