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CTRI Number  CTRI/2020/05/025383 [Registered on: 27/05/2020] Trial Registered Prospectively
Last Modified On: 01/12/2020
Post Graduate Thesis  No 
Type of Trial  BA/BE 
Type of Study    
Study Design  Randomized, Crossover Trial 
Public Title of Study   Study on 100 IU/mL Insulin Glargine injection  
Scientific Title of Study   An open label, randomized, two-treatment, two-sequence, four-period, single-dose, full replicate crossover bioequivalence study of VB70G (Insulin Glargine injection) 100 IU/mL of Virchow Biotech, Hyderabad, India and LANTUS® (Insulin Glargine injection) 100 IU/mL of Sanofi-Aventis, India in healthy male, adult, human subjects under fasting conditions. 
Trial Acronym   
Secondary IDs if Any  
Secondary ID  Identifier 
19-026; version dated 13/02/2019  Protocol Number 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  Dr K Kiran Kishore 
Designation  Prinicipal investigator 
Affiliation  Jeevan Scientifìc Technology Ltd. 
Address  Room No.1 Fourth floor, Clinical Pharmacology, B-17, TIE,Phase-ll
Balanagar Hyderabad
Hyderabad
TELANGANA
500037
India 
Phone  7659011000  
Fax  04067364707  
Email  vasudev.sureddy@jeevanscientific.com  
 
Details of Contact Person
Scientific Query  
Name  DrHemanth Nandigala 
Designation  Manging Director 
Affiliation  Virchow Biotech Private Limited 
Address  room no 1, Manging Director East Avenue,Plot No 319 and320,3rd Floor,
Swamy Ayappa Society,Madhapur, Hyderabad
Hyderabad
TELANGANA
500018
India 
Phone  04023119481   
Fax  040231194816  
Email  hnandigala@gmail.com  
 
Details of Contact Person
Public Query  
Name  DrHemanth Nandigala 
Designation  Manging Director 
Affiliation  Virchow Biotech Private Limited 
Address  room no 1, Manging Director East Avenue,Plot No 319 and320,3rd Floor,
Swamy Ayappa Society,Madhapur, Hyderabad
Hyderabad
TELANGANA
500018
India 
Phone  04023119481   
Fax  040231194816  
Email  hnandigala@gmail.com  
 
Source of Monetary or Material Support  
Virchow Biotech Private Limited East Avenue,Plot No:319 & 320,3rd Floor,Swamy Ayappa Society,Madhapur,hyderabad,Andhara Pradesh,India-500081.  
 
Primary Sponsor  
Name  Virchow Biotech Private Limited 
Address  East Avenue,Plot No:319 & 320,3rd Floor,Swamy Ayappa Society,Madhapur,hyderabad,Andhara Pradesh,India-500081. 
Type of Sponsor  Pharmaceutical industry-Indian 
 
Details of Secondary Sponsor  
Name  Address 
NIL  NIL 
 
Countries of Recruitment     India  
Sites of Study  
No of Sites = 1  
Name of Principal Investigator  Name of Site  Site Address  Phone/Fax/Email 
Dr K Kiran Kishore  Jeevan Scientific Technology Ltd.  B-17, TIE, Phase II, Balanagar, Hyderabad-500 037, India
Hyderabad
TELANGANA 		 7659011000

vasudev.sureddy@jeevanscientific.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
Institutional Ethics Committee Vasavi Medical and Research Centre  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Approved/Obtained 
 
Health Condition / Problems Studied  
Health Type  Condition 
Healthy Human Volunteers  Healthy Subjects 
 
Intervention / Comparator Agent  
Type  Name  Details 
Intervention  Insulin Glargine  A single dose of 0.4 IU/Kg, subcutaneously 
Comparator Agent  Insulin glargine of innovator  A single dose of 0.4 IU/Kg, subcutaneously 
 
Inclusion Criteria  
Age From  18.00 Year(s)
Age To  45.00 Year(s)
Gender  Male 
Details  Healthy human subjects between 18-45 years of age (including both) and weight ≥ 50 Kg (BMI 18.5 to 24.9kg/m²).
2. Acceptable findings during registration and screening including, medical history, physical examination, laboratory evaluations, 12- lead ECG and Chest X-Ray (postero-anterior view).
3. Values within normal ranges for laboratory parameters upon evaluation by the Investigator or Physician
Subjects able to communicate effectively.
5. Subjects willing to give written informed consent and adhere to all the requirements of this protocol.
6. Subject willing to abstain from all kinds of alcoholic beverages, smoking, and caffeine/xanthine containing foods or beverages from 48.00 hours before admission till the last blood sample in each Period.
7. Subjects without any evidence of impaired glucose tolerance in 2 hours oral glucose tolerance test. 
 
ExclusionCriteria 
Details  1. Volunteers having contraindication or hypersensitivity (e.g., anaphylaxis) to Insulin or related class of drugs and any of its ingredients will be excluded from the study.
2. A history or presence of significant asthma, urticaria, or other allergic-type reactions after taking aspirin or other NSAIDs. Severe, rarely fatal, anaphylactic-like reactions to NSAIDs, seizures, diabetes, migraine, hypertension, cardiovascular, pulmonary, neurological or psychiatric disease/disorder, dermatological, endocrine, immunological, hepatic, renal, hematopoietic, gastrointestinal, ongoing infectious diseases, or any other significant abnormality as evidenced by medical history and physical examination or according to the opinion of the physician.
3. History of diabetic ketoacidosis
4. History of hypoglycaemia (Symptoms include low pulse rate, watering of extremities, dizziness, weakness and sometimes fainting)
5. History or evidence of exfoliative dermatitis, Stevens - Johnson syndrome (SJS), and toxic epidermal necrolysis (TEN).
6. Any known enzyme inducing or inhibiting drug taken within 30 days before the study.
7. Participation in a drug research study within 90 days prior to dosing of this study.
8. Blood loss or whole blood donation within 90 days prior to drug administration.
9. Consumption of high caffeine (more than 5 cups of coffee or tea/day) or tobacco (more than 9 cigarettes/beedies/cigars per day).
10. History of addiction to any recreational drug or drug dependence.
11. An unusual or abnormal diet, for whatever reason within 48.00 hours prior to admission of each period, e.g. fasting due to religious reasons.
12. History of dehydration from diarrhea, vomiting or any other reason within a period of 24.00 hours prior to study check-in of each period.
13. Positive results for drugs of abuse (benzodiazepines, cocaine, opioids, amphetamines, cannabinoids and barbiturates) in urine during the study check-in of each period.
14. Positive results for alcohol breathe analysis during the study check-in of each period.
15. History of pre-existing bleeding disorder.
16. Difficulty with donating blood.
17. Systolic blood pressure less than 100 mm Hg or more than 140 mm Hg.
18. Diastolic blood pressure less than 60 mm Hg or more than 90 mm Hg.
19. Pulse rate less than 60 beats/minute or more than 100 beats/minute.
20. Use of any prescribed medication or OTC medicinal products during last two weeks preceding the first dosing.
21. History of alcohol abuse and/or dependence within six months of the screening visit or History of drug abuse or use of illegal drugs within 90 days prior to dosing of this study. 
 
Method of Generating Random Sequence   Computer generated randomization 
Method of Concealment   Centralized 
Blinding/Masking   Open Label 
Primary Outcome  
Outcome  TimePoints 
INS-AUC(0-24h), Cmax, Tmax.  0-24 hrs 
 
Secondary Outcome  
Outcome  TimePoints 
GIR-AUC(0-24h), GIRmax, TGIRmax  0-24 hrs 
 
Target Sample Size   Total Sample Size="24"
Sample Size from India="24" 
Final Enrollment numbers achieved (Total)= "24"
Final Enrollment numbers achieved (India)="24" 
Phase of Trial   Phase 1 
Date of First Enrollment (India)   27/05/2020 
Date of Study Completion (India) 30/10/2020 
Date of First Enrollment (Global)  Date Missing 
Date of Study Completion (Global) Date Missing 
Estimated Duration of Trial   Years="0"
Months="3"
Days="0" 
Recruitment Status of Trial (Global)
Modification(s)  		 Not Applicable 
Recruitment Status of Trial (India)  Completed 
Publication Details   Nil 
Individual Participant Data (IPD) Sharing Statement

Will individual participant data (IPD) be shared publicly (including data dictionaries)?  

Brief Summary
Modification(s)  		 A total of 24 healthy subjects meeting the inclusion and exclusion criteria set forth in this protocol will be enrolled in the study. In each period, fasted healthy subjects will be administered a single dose of 0.4 Units/kg of either test or reference medication by subcutaneous injection in the para umblical skinfold in accordance with the randomization scheme. 
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