| CTRI Number |
CTRI/2025/04/084540 [Registered on: 11/04/2025] Trial Registered Prospectively |
| Last Modified On: |
02/03/2026 |
| Post Graduate Thesis |
No |
| Type of Trial |
Interventional |
|
Type of Study
|
Drug
Biological |
| Study Design |
Randomized, Parallel Group, Active Controlled Trial |
|
Public Title of Study
|
Comparative Efficacy, Safety and Immunogenicity of VBLG01 to Victoza in Patients With Type 2 Diabetes |
|
Scientific Title of Study
|
A Phase III, Randomized, Parallel, Double Blind, Non-inferiority, Multicenter Study to Compare Efficacy, Safety and Immunogenicity of VBLG01 to Victoza in Patients With Type 2 Diabetes |
| Trial Acronym |
Nil |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| VBLG01/2024-CT1; Version 3; 09/09/2024 |
Protocol Number |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Dr Hemanth Nandigala |
| Designation |
Medical Officer |
| Affiliation |
Virchow Biotech Private Limited |
| Address |
Plot No 319, 320, 3rd floor East Avenue Swamy Ayappa Society
Madhapur, Hyderabad
Hyderabad
TELANGANA
500081
India |
| Phone |
9866911717 |
| Fax |
|
| Email |
hemanth@virchowbiotech.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Hemanth Nandigala |
| Designation |
Medical Officer |
| Affiliation |
Virchow Biotech Private Limited |
| Address |
Plot No 319, 320, 3rd floor East Avenue Swamy Ayappa Society
Madhapur, Hyderabad
Hyderabad
TELANGANA
500081
India |
| Phone |
9866911717 |
| Fax |
|
| Email |
hemanth@virchowbiotech.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Hemanth Nandigala |
| Designation |
Medical Officer |
| Affiliation |
Virchow Biotech Private Limited |
| Address |
Plot No 319, 320, 3rd floor East Avenue Swamy Ayappa Society
Madhapur, Hyderabad
Hyderabad
TELANGANA
500081
India |
| Phone |
9866911717 |
| Fax |
|
| Email |
hemanth@virchowbiotech.com |
|
|
Source of Monetary or Material Support
|
|
|
Primary Sponsor
|
| Name |
Virchow Biotech Private Limited |
| Address |
Virchow Biotech Private Limited
Plot No: 4, S.V. Co-operative Indl Estate
IDA Jeedimetla
Hyderabad -500 055
|
| Type of Sponsor |
Pharmaceutical industry-Indian |
|
|
Details of Secondary Sponsor
|
|
|
Countries of Recruitment
|
India |
Sites of Study
Modification(s)
|
| No of Sites = 10 |
| Name of Principal
Investigator |
Name of Site |
Site Address |
Phone/Fax/Email |
| Dr Nikhil Verma |
ESIC Medical College & Hospital |
3rd floor ICU, OPD Building, Clinical trial unit, MRU, Basement, NH-3,NIT, Faridabad, Haryana, India-121001.
Faridabad
HARYANA |
8447748603
drnick.ver@gmail.com |
| Dr SSVV Narasinga Rao |
Govt. Medical College & Govt.General Hospital (old RIMSGGH) |
OPD No: 13, First floor, Dept of General Medicine, Srikakulam Andhra
Pradesh - 532001 India
Srikakulam
ANDHRA PRADESH |
8942279033
drnarasingaraossvv@yahoo.com |
| Dr Shravan Kumar Ankathi |
Mahatma Gandhi Memorial Hospital |
Room no. 100, diabetic clinic, OPD Block, 1st floor, Dept. of clinical research, Dept. of Medicine, Sherpura, Warangal, Telangana, 506002.
Warangal
TELANGANA |
9985579753
drshravanankathi.krcwgl@gmail.com |
| Dr Anikethana GV |
Mandya Institute of Medical Sciences |
Room No. 4, ground floor, Dept of general medicine,Bengaluru - Mysuru Main Road, Mandya - 571401,
Karnataka, India
Mandya
KARNATAKA |
9448576836
anikethana.g.v@gmail.com |
| Dr A Gopal Rao |
Medigene Multispeciality Hospital Private Limited (Akshaya Hospital) |
Room No.1, Ground floor, Dept. of General Medicine,
Railway New Colony, Visakhapatnam, Andhra Pradesh 530016
Visakhapatnam
ANDHRA PRADESH |
9440122790
drgopalraoa@gmail.com |
| Dr Harshavardhan L |
Mysore Medical College and Research Institute (KR Hospital) |
OPD Room 3, Dept. of Endocrinology,
Irwin Road, next to Railway Staion, Mysuru, Karnataka 570001
Mysore
KARNATAKA |
9663515531
harshavardhanmed@gmail,com |
| Dr Biplab Mandal |
North Bengal Medical College & Hospital |
OPD room No. 101, Dept. of General Medicine, Sushrutanagar, Siliguri, Darjeeling West Bengal, India 734012
Kolkata
WEST BENGAL |
9434255272
drbiplabmandal@gmail.com |
| Dr Amar Suresh Raykantiwar |
Silver Brich Multispeciality Hospital |
S No.6, Plot no.4, Near Sawatamali Mandir, Narhe- Dhayari Road, Pune-411041.
Pune
MAHARASHTRA |
8451941050
dr.amarray26@gmail.com |
| Dr Naveen Korivi |
St. Ann’s General and Cancer Hospital |
Room No.1, first floor, Dept of General Medicine,
Kazipet, Warangal, Telangana 506004
Warangal
TELANGANA |
7989906937
drnaveenkorivi.krcwgl@gmail.com |
| Dr Macherla Kiran Kumar |
St. Theresa Hospital |
Ground Floor, OPD, Dept of General Medicine, Sanathnagar, Opp. Erragadda Raitu Bazar,Hyderabad, Telangana - 500018 India
Hyderabad
TELANGANA |
8008220098
drkiranmacherla@gmail.com |
|
Details of Ethics Committee
Modification(s)
|
| No of Ethics Committees= 10 |
| Name of Committee |
Approval Status |
| Central Independent Ethics Committee |
Approved |
| Ethics committee St Theresas Hospital |
Approved |
| IEC North Bengal Medical College And Hospital |
Approved |
| IEC-MMC and RI and Associated Hospitals |
Submittted/Under Review |
| Institution Ethics Committee, MIMS, Mandya Mandya Institute of Medical Sciences |
Approved |
| Institutional Ethics Committee for ESIC |
Submittted/Under Review |
| Institutional Ethics Committee Govt. Medical College Govt.General Hospital |
Approved |
| Institutional Ethics Committee Medigene, Multispeciality Hospital Private Limited |
Approved |
| Kakatiya Institutional Ethics Committee |
Approved |
| St. Anns Institutional Ethics Committee ST. ANNS HOSPITAL |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
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 |
| Intervention |
VBLG01 |
Dose:
• Liraglutide will be started at dose of 0.6 mg daily by subcutaneous injection to improve gastrointestinal tolerability;
• After at least 1 week dose increased to 1.2 mg/day for a duration of at least 1 week and there after dose maintained at 1.2 mg / day or increased to 1.8 mg / day depending on glycemic control.
ROA: Subcutaneous
Duration: 24 weeks |
| Comparator Agent |
Victoza |
Dose:
• Liraglutide will be started at dose of 0.6 mg daily by subcutaneous injection to improve gastrointestinal tolerability;
• After at least 1 week dose increased to 1.2 mg/day for a duration of at least 1 week and there after dose maintained at 1.2 mg / day or increased to 1.8 mg / day depending on glycemic control.
ROA: Subcutaneous
Duration: 24 weeks |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
65.00 Year(s) |
| Gender |
Both |
| Details |
1. Male or female patients aged between 18 – 65 years.
2. Patients with Type 2 diabetes treated with oral antidiabetic drugs (OADs) like metformin and/or sulfonylureas and/or alpha glucosidase inhibitors and/or sodium-glucose co-transporter 2 (SGLT2) inhibitors at stable dose for at least 3 months before screening.
3. Patients with glycosylated hemoglobin ≥7 to ≤10%.
4. Patients with a body mass index of greater than or equal to 23 kg/m2 and less than or equal 45 kg/m2.
5. Women of childbearing potential should agree to use suitable method of contraception throughout the study.
6. Ability and willingness to take daily injections to abdomen, thigh or upper arm.
7. Ability and willingness to adhere to the protocol requirements.
|
|
| ExclusionCriteria |
| Details |
1.Patients with significant liver, cardiac or gastrointestinal disease.
2.Hypersensitivity to liraglutide or any component of the formulation.
3.Insulin treatment during the previous 3 months - except short-term treatment for intercurrent illness.
4.Impaired liver function - (ALT, AST, ALP concentrations greater than or equal to 2·5 times upper normal range.
5. Impaired renal function - eGFR lessthan 60 mL/min/1.73 m2).
6.Uncontrolled hypertension greater than or equal to160/100 mm Hg.
7.Malignancy.
8.Used any drugs apart from OGLAs likely to affect glucose concentrations, including androgens, hyperglycaemia-associated agents, hypoglycaemia-associated agents, MAO inhibitors, quinolone antibiotics, salicylates -Anti-inflammatory dose.
9.Treatment with dipeptidyl peptidase 4 inhibitors.
10.Treatment with systemic corticosteroids.
11.History or family history of medullary thyroid carcinoma.
12.Multiple endocrine neoplasia syndrome type 2.
13.History of pancreatic cancer and pancreatitis.
14.History of recent MI, uncontrolled CHF, and unstable angina.
15.History or known case of severe non-proliferative diabetic retinopathy or proliferative diabetic retinopathy.
16.Pregnancy.
17.Previous exposure to exenatide or liraglutide.
|
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
Centralized |
|
Blinding/Masking
|
Participant and Investigator Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Mean change in reduction in the HbA1c from baseline to 24 weeks |
Mean change in reduction in the HbA1c from baseline to 24 weeks |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
1.Mean change in fasting plasma glucose (FPG) from baseline to 24 weeks.
2.Mean change in post-prandial blood sugar (PPBS) from baseline to 24 weeks.
3.Percentage of subjects with HbA1c less than 7% at 24 weeks.
4.Percentage of subjects with HbA1c less than or equal to 6.5% at 24 weeks.
5.Change in body weight from baseline to 24 weeks.
6.Incidence and severity of hypoglycaemic events.
|
24 weeks |
|
|
Target Sample Size
|
Total Sample Size="226"
Sample Size from India="226"
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)
|
15/04/2025 |
| 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)
Modification(s)
|
Not Applicable |
| 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
|
The current study is a double-blind, randomized phase III comparative clinical study expected to be conducted on 226 patients with type 2 diabetes. The study expected to last for a maximum of 26 weeks/patient. Visit 1 will be
considered as screening visit. On visit 2 (day 1) patients will be receiving
the investigational products as per the randomization along with oral
antidiabetic drugs (OADs) like metformin and/or sulfonylureas and/or alpha
glucosidase inhibitors and/or sodium-glucose co-transporter 2 (SGLT2)
inhibitors. Patients will continue the treatment (liraglutide and OADs) from
visit 3 to visit 11. Visit 12 will be
study termination visit. In addition, patients will be further follow-up for one
week for safety assessment. |