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CTRI Number  CTRI/2024/11/076296 [Registered on: 05/11/2024] Trial Registered Prospectively
Last Modified On: 22/05/2025
Post Graduate Thesis  No 
Type of Trial  Interventional 
Type of Study   Drug 
Study Design  Randomized, Parallel Group, Active Controlled Trial 
Public Title of Study   Phase III comparative study to assess the Efficacy and Safety of VB70G (Insulin Glargine Injection 100 Units/mL) with LANTUS in Type 2 DM patients 
Scientific Title of Study   A Phase III, Randomized, Controlled, Open-Label, Multicenter, Parallel Comparative study to assess the Efficacy and Safety of VB70G (Insulin Glargine Injection 100 Units/mL) with LANTUS in Type 2 Diabetes Mellitus patients with Uncontrolled Oral Antidiabetic therapy 
Trial Acronym  Nil 
Secondary IDs if Any  
Secondary ID  Identifier 
VB70G/2024-CT2; version 1; dated 12.01.2024  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 and 320, East Avenue Building, Ayyappa Society
Madhapur
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 and 320, East Avenue Building, Ayyappa Society
Madhapur
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 and 320, East Avenue Building, Ayyappa Society
Madhapur
Hyderabad
TELANGANA
500081
India 
Phone  9866911717  
Fax    
Email  hemanth@virchowbiotech.com  
 
Source of Monetary or Material Support  
Nil 
 
Primary Sponsor  
Name  Virchow Biotech Private Limited 
Address  M/s. Virchow Biotech Pvt. Ltd., Plot No: 4, S.V. Co-operative Indl Estate IDA Jeedimetla Hyderabad -500 055  
Type of Sponsor  Pharmaceutical industry-Indian 
 
Details of Secondary Sponsor  
Name  Address 
Nil   
 
Countries of Recruitment     India  
Sites of Study
Modification(s)  
No of Sites = 14  
Name of Principal Investigator  Name of Site  Site Address  Phone/Fax/Email 
Dr A Gopal Rao  Akshaya Hospital Medigene Multispeciality Hospital Private Limited  OPD no: 1 , Ground floor, OPD block,Vishakapatnam-530016, Andhra Pradesh, India
Visakhapatnam
ANDHRA PRADESH 		 8912510215

drgopalraoa@gmail.com 
Dr Aman Romesh Khanna  Aman Hospital and Research Center  Ground floor PI consultant room, 15 Shaswat, Gotri Rd, opposite ESI Hospital, Vadodara, Gujarat 390021
Vadodara
GUJARAT 		 9904402122

amankhanna1947@gmail.com 
Dr Paparao Nadakuduru  Citizens Hospital  PI OPD room: 09, 1st floor, Department of Medicine, Nallagandla, Sherilingampally, Hyderabad, Telangana 500019
Hyderabad
TELANGANA 		 9848429199

drpaparao@gmail.com 
Dr Arindam Ray  College of Medicine and Sagore Dutta Hospital  2nd floor, OPD Building,Room no8,Medicine Department, 578 B.T Road, Kamarhati Kolkata, West Bengal - 700058 India
Kolkata
WEST BENGAL 		 9477058636

rayarindam09@gmail.com 
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 Sunil Naik  Govt. Medical College & Govt.General Hospital (Old RIMs GGH)  OPD no:13 ,1st floor and clinical research department 2nd floor, Srikakulam Andhra Pradesh - 532001 India
Srikakulam
ANDHRA PRADESH 		 8942279033

drsunilnaikggh@gmail.com 
Dr Saurabh Agarwal  GSVM Medical College  Room No.7, Ground Floor, Post graduate Department of Medicine, GSVM Medical College, Kanpur-208002, UP, India
Kanpur Nagar
UTTAR PRADESH 		 9415039582

dr.saurabhagarwal@gmail.com 
Dr Sravani Tanna  KIMS ICON HOSPITAL  room number 17, OP block First floor, Visakhapatnam-530012, Andhra Pradesh, India
Visakhapatnam
ANDHRA PRADESH 		 8008926520

sravani.tanna@gmail.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 		 9985579754

drshravanankathi.krcwgl@gmail.com 
Dr Anikethana G V  Mandya Institute of Medical Sciences  Room no 14, Ground floor,Deptartment of General Medicine,Mandya Institute of Medical Sciences, Mandya-571401, Karnataka, India
Bangalore
KARNATAKA 		 9448576836

anikethana.g.v@gmail.com 
Dr Niladri Das  Nil Ratan Sircar Medical College and Hospital   Department of Endocrinology, 2nd Floor,Room no.138, Acharya Jagdish Chandra Bose Road, Kolkata - 700014, West Bengal, India
Kolkata
WEST BENGAL 		 7003103486

dr.niladridas90@gmail.com 
Dr Sravanthi Turpati  Queens NRI Hospital  Room No. 2, Ground floor, Department of General Medicine, d.no. 50-53-14, Gurudwara Rd, Balayya Sastri Layout, Seethammadara, Visakhapatnam, Andhra Pradesh 530013
Visakhapatnam
ANDHRA PRADESH 		 9052560661

sweetsravanthi@gmail.com 
Dr Naveen Korivi  St. Anns General and Cancer Hospital   Room No"1, Ground Floor, Dept of General Medicine, Kazipet, Warangal, Telangana 506004
Warangal
TELANGANA 		 7989906937

drnaveenkorivi.krcwgl@gmail.com 
Dr Praveenkumar Devarbhavi  Subbaiah Institute of Medical Sciences  Room no_5 Ground floor Department of General medicine Shimoga Karnataka-577222, India
Shimoga
KARNATAKA 		 9986108182

devarbhavi.endocrine@gmail.com 
 
Details of Ethics Committee
Modification(s)  
No of Ethics Committees= 14  
Name of Committee  Approval Status 
Citizens Institutional Ethics Committee   Submittted/Under Review 
College of Medicine and Sagore dutta Hospital  Submittted/Under Review 
Ethics Committee GSVM Medical College   Submittted/Under Review 
Ethics Committee N.R.S Medical College   Approved 
Ethics Committee Subbaiah Institute of Medical Sciences   Approved 
IEC King George hospital  Approved 
Institution Ethics Committee, MIMS, Mandya  Approved 
Institutional Ethics Committee for ESIC   Approved 
Institutional Ethics Committee KIMS Icon Hospital  Approved 
Institutional Ethics Committee, Aman Hospital and Research Center  Approved 
Institutional Ethics Committee, Govt. Medical College Govt. General Hospital  Approved 
Institutional Ethics Committee, Queens NRI Hospital  Approved 
Kakatiya Institutional Ethics Committee  Approved 
St. Anns Institutional Ethics Committee ST. ANNS HOSPITAL  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Approved/Obtained 
 
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  Lantus - Insulin Glargine  Dose: 10 units/day or 0.2 units /kg/day + OADs Frequency: Daily once ROA: subcutaneous Total duration: 24 weeks  
Intervention  VB70G - Insulin Glargine  Dose: 10 units/day or 0.2 units /kg/day + OADs Frequency: Daily once ROA: subcutaneous Total 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 mellitus based on the disease diagnostic criteria of World Health Organization (WHO) classification ([fasting plasma glucose ≥ 7.0mmol/l (≥126mg/dl) or 2–h plasma glucose ≥ 11.1mmol/l (≥200mg/dl)].)
3. Patients who have been taking at least 2 types of oral diabetes medications [≥ two drugs- AGI (α-Glucosidase inhibitors), DPP-4 (Dipeptidyl peptidase-4) inhibitors, MEG (Meglitinides), MET (metformin), SU (Sulfonylureas)] for at least 12 weeks prior to entering the study.
4. Patients with HbA1c ≥7% and ≤10%.
5. Patients with a body mass index of less than or equal to 35 kg/m2.
 
 
ExclusionCriteria 
Details  1. Type 1 diabetes mellitus patients.
2. Patients with significant liver, cardiac or gastrointestinal disease.
3. Patients with active cancer or have had cancer within the past 5 years (with the exception of basal cell carcinoma or carcinoma in situ)
4. Patients who are having an excessive resistance to insulin or hypersensitivity to insulin glargine.
5. Patients who had more than one episode of severe low blood sugar (defined as needing someone else to help because of very low blood sugar) within the 6 months before entering the study
6. Patients who have taken any other insulin other than insulin glargine within the past 30 days
7. Taking any other diabetes medicines that are not allowed in the study or not approved to be taken with insulin.
8. Patients on self-monitoring of blood glucose less than 6 months before screening visit;
9. Patients using pre-mix insulins, insulin detemir at 2 times or more a day, or GLP 1 receptor agonists in the last 3 months before screening visit;
10. Patients using mealtime insulin (rapid-acting insulin analogue and short-acting insulin) for more than 10 days in the last 3 months before screening visit;
11. Use of insulin pump in the last 6 months before screening visit;
12. Initiation of new glucose-lowering medications and/or weight loss drugs in the last 3 months before screening visit;
13. Unstable proliferative diabetic retinopathy or any other rapidly progressive diabetic retinopathy or macular oedema likely to require treatment (eg, laser, surgical treatment or injectable drugs) during the study period.
 
 
Method of Generating Random Sequence   Computer generated randomization 
Method of Concealment   An Open list of random numbers 
Blinding/Masking   Not Applicable 
Primary Outcome  
Outcome  TimePoints 
Change in Hb1Ac from baseline to 24 weeks  Week 24  
 
Secondary Outcome  
Outcome  TimePoints 
Change in FPG from baseline to 24 weeks

change in SMPG from baseline to 24 weeks

percentage of participants with HbA1c lessthan 7 percent and lessthan 6.5 percent at week 4, 8, 12, 16 20 and 24 weeks

Incidence of hypoglycemic events 		 Week 24

Week 24

Week 4, 8, 12, 16, 20 and 24 
 
Target Sample Size   Total Sample Size="230"
Sample Size from India="230" 
Final Enrollment numbers achieved (Total)= "0"
Final Enrollment numbers achieved (India)="0" 
Phase of Trial   Phase 3 
Date of First Enrollment (India)   15/11/2024 
Date of Study Completion (India) Date Missing 
Date of First Enrollment (Global)  Date Missing 
Date of Study Completion (Global) Date Missing 
Estimated Duration of Trial   Years="1"
Months="6"
Days="0" 
Recruitment Status of Trial (Global)   Not Applicable 
Recruitment Status of Trial (India)  Completed 
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 a phase III, randomised, controlled, comparative, open-label, multicenter study in India. The duration of the study for each subject is 29 weeks, which includes a 1-week screening period, 24 weeks treatment and follow-up visit after 4 weeks of 6 months treatment.As per the randomization the drugs to be administered 10 units or 0.2 units/kg once daily subcutaneously before sleep along with oral antidiabetic. The dose of recombinant insulin glargine needs to be adjusted till FPG value is ≤120 mg/dL is achieved. Dose to be adjusted at every 3 days by 2 units upto a maximum of 100 units. Investigators can decrease the insulin dose for patients who experience hypoglycemia on their active dose. All the patients will be followed for 4 weeks post treatment safety after 6 months duration

 

 
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