| CTRI Number |
CTRI/2024/10/074905 [Registered on: 08/10/2024] Trial Registered Prospectively |
| Last Modified On: |
04/03/2025 |
| Post Graduate Thesis |
No |
| Type of Trial |
Interventional |
|
Type of Study
|
Drug |
| Study Design |
Randomized, Parallel Group, Multiple Arm Trial |
|
Public Title of Study
|
A research study comparing how well different doses of the medicine NNC0519-0130 lower blood sugar in people with type 2 diabetes |
|
Scientific Title of Study
|
Investigation of the safety and efficacy of once weekly NNC0519-0130 in
participants with type 2 diabetes – a dose finding study |
| Trial Acronym |
NILL |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| 166079 |
Other |
| U1111-1291-9196 |
UTN |
| Version 2.0, NN9541-4945, dated 08 January 2024 |
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
|
| Name |
Dr Maya Sharma |
| Designation |
Vice President Clinical, Medical, Regulatory and Pharmacovigilance |
| Affiliation |
Novo Nordisk India Private Limited |
| Address |
Novo Nordisk India Private Limited, Nxt Tower - 2, Floor 1 and 2, Embassy Manyata Business Park, Nagavara Village, Kasaba Hobli,
Bangalore
KARNATAKA
560045
India |
| Phone |
9911497869 |
| Fax |
|
| Email |
yrms@novonordisk.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Maya Sharma |
| Designation |
Vice President Clinical, Medical, Regulatory and Pharmacovigilance |
| Affiliation |
Novo Nordisk India Private Limited |
| Address |
Novo Nordisk India Private Limited, Nxt Tower - 2, Floor 1 and 2, Embassy Manyata Business Park, Nagavara Village, Kasaba Hobli
Bangalore
KARNATAKA
560045
India |
| Phone |
9911497869 |
| Fax |
|
| Email |
yrms@novonordisk.com |
|
Source of Monetary or Material Support
Modification(s)
|
| Novo Nordisk AS Novo Allé, 2880 Bagsvaerd Denmark |
|
Primary Sponsor
Modification(s)
|
| Name |
Novo Nordisk India Pvt 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
|
Australia
Canada
India
Japan
Republic of Korea
South Africa
United States of America |
Sites of Study
Modification(s)
|
| No of Sites = 8 |
| Name of Principal
Investigator |
Name of Site |
Site Address |
Phone/Fax/Email |
| Dr Harish Kumar |
Amrita Institute of Medical Sciences and Research Centre |
Dept. of Endocrinology, A1 Block, 6th floor. Room No:5, AIMS-Ponekkara.P.O, Kochi-682041, Kerala, India
Ernakulam
KERALA |
9895545190
harishkumar@aims.amrita.edu |
| Dr Unnikrishnan A G |
Chellaram Diabetes Institute |
1st floor, Lalani Quantum, Pune- Bangalore, NH-04, Opp. Calsoft building, Bavdhan(Budruk), Pune 411021- Maharashtra
Pune
MAHARASHTRA |
9689287337
uagcdi@cdi.org.in |
| Dr Felix Jebasingh |
Christian Medical College |
810, Department of Endocrinology Diabetes and Metabolism, Vellore-4, Tamil Nadu
Vellore
TAMIL NADU |
8098469771
felixjebasingh@cmcvellore.ac.in |
| Dr Vishu Priya Paturi Rao |
Diabetes Research Center |
6-3-349/17B & 31, Hindi Nagar Colony, Behind Panjagutta Saibaba Temple, Panjagutta, Hyderabad - 500082, Telangana.
Hyderabad
TELANGANA |
4026661331
raopaturi@gmail.com |
| Dr Surendra Kumar Sharma |
Diabetes Thyroid and Endocrine Centre |
A-1, Madrampura Ajmer Road, Near 4 no. ESI Hospital, Sodala, Jaipur-302006, Rajasthan, India
Jaipur
RAJASTHAN |
9829010233
sksharmacr@gmail.com |
| Dr L Sreenivasamurthy |
Lifecare Hospital and Research centre |
2748 2152, M.L.N Enclave, 16th E cross, 8th main, D block next to Union Bank of India Sahakarnagar Bengaluru 560092
Bangalore
KARNATAKA |
9448051046
drlsm@lcrc.in |
| Dr Chitra Selvan |
M S Ramaiah Medical College and Hospitals |
M S Ramaiah Nagar, MSRIT Post, Bangalore-560054, Karnataka, India
Bangalore
KARNATAKA |
8197132111
chitraselvan@gmail.com |
| Dr Tushar Ramakrishna Bandgar |
Seth G S Medical College and KEM Hospital |
Acharya Donde Marg, Parel, Mumbai - 400012
Mumbai
MAHARASHTRA |
9820025037
drtusharb@gamil.com |
|
Details of Ethics Committee
Modification(s)
|
| No of Ethics Committees= 8 |
| Name of Committee |
Approval Status |
| Chellaram Diabetes Institute-Institutional Ethics Committee |
Approved |
| Ethics Committee |
Approved |
| Human Welfare- Ethical committee for human sciences and research |
Approved |
| Institutional Ethics Committee - Diabetes Research Centre |
Approved |
| Institutional Ethics Committee- Amrita Institiue of Medical Science |
Approved |
| Institutional Ethics Committee- Seth GS Medical College |
Approved |
| Institutional Review Board-Ethics Committee Silver |
Approved |
| Lifecare Hospital Institutional Review Board |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: E11||Type 2 diabetes mellitus, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
NNC0519-0130 |
Pharmaceutical form : Solution for injection
Route of administration Subcutaneous (s.c.)
Dose: 24mg
Dose frequency: Once weekly
total duration :36 Week
|
| Intervention |
Placebo |
Pharmaceutical form : Solution for injection
Route of administration Subcutaneous (s.c.) Dose: 0 mg
Dose frequency: Once weekly total duration :36 Week |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
75.00 Year(s) |
| Gender |
Both |
| Details |
1.Female of non-childbearing potential, or male.
2.Age 18-75 years (both inclusive) at the time of signing the informed consent.
3.Diagnosed with type 2 diabetes mellitus more than or equal to 180 days before screening.
4.Stable daily dose(s) more than or equal to 90 days before screening of the following antidiabetic drug(s) or
combination regimen(s) at effective or maximum tolerated dose as judged by the
investigator: metformin with or without SGLT2 inhibitor.
5.HbA1c of 7.5-10.0 percent (58-86 mmol per mol) (both inclusive) as assessed by central laboratory at
screening.
6.BMI more than or equal to 23.0 kg per m2.
|
|
| ExclusionCriteria |
| Details |
1.Treatment with any medication for the indication of diabetes or obesity other than stated in the
inclusion criteria within 90 days before screening. However, short term insulin treatment for a maximum of 14 consecutive days and prior insulin treatment for gestational diabetes are
allowed.
2.Uncontrolled and potentially unstable diabetic retinopathy or maculopathy. Verified by a fundus
examination performed within 90 days before screening or in the period between screening and
randomisation. Pharmacological pupil-dilation is a requirement unless using a digital fundus
photography camera specified for non-dilated examination.
3.Known hypoglycaemic unawareness as indicated by the investigator according to Clarke’s
questionnaire question. |
|
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Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
Centralized |
|
Blinding/Masking
|
Participant and Investigator Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Change in HbA1c |
From baseline (week 0) to
12 weeks on a given
maintenance dose |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Change in body weight |
From baseline (week 0) to
end of treatment (week 36) |
| Change in fasting plasma glucose (FPG) |
From baseline (week 0) to
12 weeks on a given maintenance dose |
Continuous glucose
monitoring (CGM)
Change in time in range (TIR) 3.9–10.0 mmol per L (70–180 mg per dL) |
From baseline (week -2 to
week 0) to week 22-24 and
week 34-36, respectively |
Number of adverse
events |
From baseline (week 0) to
end of study (week 40) |
|
|
Target Sample Size
|
Total Sample Size="418"
Sample Size from India="55"
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 2 |
|
Date of First Enrollment (India)
|
21/10/2024 |
| Date of Study Completion (India) |
Applicable only for Completed/Terminated trials |
| Date of First Enrollment (Global) |
18/03/2024 |
| Date of Study Completion (Global) |
Applicable only for Completed/Terminated trials |
|
Estimated Duration of Trial
|
Years="1"
Months="3"
Days="27" |
|
Recruitment Status of Trial (Global)
|
Closed to Recruitment of Participants |
| Recruitment Status of Trial (India) |
Closed to Recruitment of Participants |
|
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
|
This is an interventional, 36-week, multi-national, multi-centre, randomised, 11-armed, dosefinding, phase 2 study. The study will be double-blinded within dose level of once weekly (QW) subcutaneously (s.c.) administered NNC0519-0130 and the corresponding volume-matched placebo arms. The active comparator arm with tirzepatide will be open label |