| CTRI Number |
CTRI/2020/09/027956 [Registered on: 22/09/2020] Trial Registered Prospectively |
| Last Modified On: |
17/06/2022 |
| Post Graduate Thesis |
No |
| Type of Trial |
Interventional |
|
Type of Study
|
Biological |
| Study Design |
Randomized, Crossover Trial |
|
Public Title of Study
|
A Phase I Clinical study to evaluate PK & PD of GeneSys Insulin Glargine. |
|
Scientific Title of Study
|
An open label, randomized, two-treatment, two-sequence, four-period, single-dose, full replicate crossover bioequivalence study of GEN1501 (Insulin Glargine Injection) 100 U/mL of GeneSys Biologics Pvt. Ltd., Hyderabad, India and LANTUS® (Insulin Glargine Injection) 100 U/mL of Sanofi-Aventis, in healthy male, adult, human subjects under fasting conditions. |
| Trial Acronym |
GEN1501 |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| Protocol No. 19-056 V. No. 02, Amendment 01, Dt: 26.06.2020 |
Protocol Number |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Dr Sowmya Bondalapati |
| Designation |
Principal Investigator, Clinical Pharmacology Department |
| Affiliation |
Jeevan Scientific Technology Limited, |
| Address |
Room No. 1
No.: B-17, TIE, Phase II, Balanagar
Hyderabad
TELANGANA
500037
India |
| Phone |
9908999994 |
| Fax |
04067364707 |
| Email |
vasudev.sureddy@jeevanscientific.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Mr Venkat Reddy Yelma |
| Designation |
Managing Director |
| Affiliation |
GeneSys Biologics Pvt. Ltd. |
| Address |
Department: Management
GeneSys Biologics Pvt. Ltd, Plot No. 9A, Genome Valley,
Biotech Park, Phase II(Extn.,), Lalgadi Malakpet, Shamirpet
Medchal
TELANGANA
500101
India |
| Phone |
7032777481 |
| Fax |
04023110044 |
| Email |
venkat@genesysbiologics.com |
|
Details of Contact Person
Public Query
|
| Name |
Mr Venkat Reddy Yelma |
| Designation |
Managing Director |
| Affiliation |
GeneSys Biologics Pvt. Ltd. |
| Address |
Department: Management
GeneSys Biologics Pvt. Ltd, Plot No. 9A, Genome Valley,
Biotech Park, Phase II(Extn.,), Lalgadi Malakpet, Shamirpet
Medchal
TELANGANA
500101
India |
| Phone |
7032777481 |
| Fax |
04023110044 |
| Email |
venkat@genesysbiologics.com |
|
|
Source of Monetary or Material Support
|
| GeneSys Biologics Pvt. Ltd.,
Plot No. 9/A,
Genome Valley,
Biotech Park, Phase-II, Shameerpet,
Medchal-Malkajgiri – 500101,
Telangana, India
|
|
|
Primary Sponsor
|
| Name |
GeneSys Biologics Pvt Ltd |
| Address |
Plot No. 9/A, Genome Valley, Biotech Park, Phase-II, Shameerpet, Medchal-Malkajgiri – 500101, Telangana, India |
| Type of Sponsor |
Pharmaceutical industry-Indian |
|
|
Details of Secondary Sponsor
|
|
|
Countries of Recruitment
|
India |
|
Sites of Study
|
| No of Sites = 1 |
| Name of Principal
Investigator |
Name of Site |
Site Address |
Phone/Fax/Email |
| Dr Sowmya Bondalapati |
Jeevan Scientific Technology Ltd |
Clinical Pharmacology Department,
Room No. 1
B-17, TIE, Phase II,
Balanagar,
Hyderabad-500037,
India
Hyderabad
TELANGANA |
7659011000
04067364707
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
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Healthy Human Volunteers |
Healthy |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
GEN1501 |
Dose: 0.4 Units/Kg
Frequency: Single dose
Route of Administration: Subcutaneous
Duration of Therapy: Single Dose |
| Comparator Agent |
Lantus |
Dose: 0.4 Units/Kg
Frequency: Single dose
Route of Administration: Subcutaneous
Duration of Therapy: Single Dose |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
45.00 Year(s) |
| Gender |
Male |
| Details |
1. Healthy human subjects between 18-45 years of age (including both) and weight ≥ 50 Kg (BMI 18.5 to 24.9 kg/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. HbA1c levels <5.7%
4. Normal range for OGTT
5. Values within normal ranges for laboratory parameters upon evaluation by the Investigator or Physician.
6. Subjects able to communicate effectively.
7. Subjects willing to give written informed consent and adhere to all the requirements of this protocol.
8. 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.
9. Subjects without any evidence of impaired glucose tolerance in 2:00 hours oral glucose tolerance test. |
|
| ExclusionCriteria |
| Details |
1. Volunteers having a known history of contraindication or hypersensitivity (e.g., anaphylaxis) to Insulin or any of its related group of drugs 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 or presence of gastrointestinal (GI) inflammation, bleeding, ulceration, and perforation of the stomach, small intestine, or large intestine.
4. History or evidence of exfoliative dermatitis, Stevens - Johnson syndrome (SJS), and toxic epidermal necrolysis (TEN).
5. Any known enzyme inducing or inhibiting drug taken within 30 days before the study.
6. Participation in a drug research study within 90 days prior to dosing of this study.
7. Blood loss or whole blood donation within 90 days prior to drug administration.
8. Consumption of high caffeine (more than 5 cups of coffee or tea/day) or tobacco (more than 9 cigarettes/beedies/cigars per day).
9. History of addiction to any recreational drug or drug dependence.
10. 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.
11. 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.
12. Positive results for drugs of abuse (benzodiazepines, cocaine, opioids, amphetamines, cannabinoids and barbiturates) in urine during the study check-in of each period.
13. Positive results for alcohol breathe analysis during the study check-in of each period.
14. History of pre-existing bleeding disorder.
15. Difficulty in swallowing solids like tablets or capsules.
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), INS-Cmax, Tmax. |
0-24 hours |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| GIR-AUC(0-24h), GIRmax, TGIRmax |
0-24 hours |
|
|
Target Sample Size
|
Total Sample Size="40"
Sample Size from India="40"
Final Enrollment numbers achieved (Total)= "40"
Final Enrollment numbers achieved (India)="40" |
|
Phase of Trial
|
Phase 1 |
|
Date of First Enrollment (India)
|
01/10/2020 |
| Date of Study Completion (India) |
28/09/2021 |
| 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)?
Response - NO
|
|
Brief Summary
|
The purpose of this study is to assess and compare the pharmacokinetic and pharmacodynamic properties of GEN1501 with Lantus® |