CTRI/2023/03/050804 [Registered on: 17/03/2023] Trial Registered Prospectively
Last Modified On:
21/01/2025
Post Graduate Thesis
No
Type of Trial
Interventional
Type of Study
Biological
Study Design
Randomized, Parallel Group, Active Controlled Trial
Public Title of Study
A Phase III clinical study to evaluate efficacy and safety of GeneSys Insulin Glargine
Scientific Title of Study
A Randomized, Assessor Blind, Active-Controlled, Multicenter, Parallel Group, Non-Inferiority Study to compare the Efficacy and Safety of GEN1501 (Insulin Glargine (r-DNA Origin) Injection 100 Units/mL) of GeneSys Biologics Pvt. Ltd., India with LANTUS® (Insulin Glargine (r-DNA Origin) Injection 100 Units/mL) in patients with Type 2 Diabetes Mellitus on Uncontrolled Oral Antidiabetic therapy (OAD)
Trial Acronym
Secondary IDs if Any
Secondary ID
Identifier
AR001-21 Ver. No. 01, Dt: 05 Nov 2021
Protocol Number
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
Name
Dr Sowmya Bondalapati
Designation
Overall Trial Co-ordinator
Affiliation
ADVITY Research Pvt. Ltd.,
Address
Archies Continental,
Adj: Kukatpally Metro station, Kukatpally
Opposite Voltas Company
Sanathnagar Hyderabad TELANGANA
8309750682
dr.kspandana92@gmail.com
Dr Rajendran Kannan
Saveetha Medical College Hospital
Saveetha Nagar Thandalam Chennai
Tamil Nadu - 602105 India Chennai TAMIL NADU
9710 071 284
endork@yahoo.com
Dr Abhishek Arun
Shekhar Hospital PVT LTD
NH001, CC, B Block, Chauraha, Indira Nagar, Lucknow-226016, Uttar Pradesh, India Lucknow UTTAR PRADESH
9455 388 302
dr.abhishekarun@gmail.com
Dr Mayank Thakkar
Shree Giriraj Multispeciality Hospital
150 ft Road, 27- Navjyot Park Main Road, Amin Marg cross road Rajkot GUJARAT
9909971118
drmayankthakker@gmail.com
Dr Girija Subramanian
Sri Manakula Vinayagar Medical College and Hospital
Kalitheerthal Kuppam, Madagadipet, Puducherry-605 107 India Pondicherry PONDICHERRY
9894 976 919
gm.girijas@smvmch.ac.in
Dr Harshal Vilas Chaudhari
Trauma Care
Ajgaokar Plot, western Express Highway, Jogeshwari East Mumbai MAHARASHTRA
9864221208
harshalchaudhari1990@gmail.com
Dr Konatham Rambabu
VISAKHA INSTITUTE OF MEDICAL SCIENCES(VIMS)
VISAKHA INSTITUTE OF MEDICAL SCIENCES(VIMS) S.NO 97/2, HANUMANTHAWAKA
CHINAGADILLI VILLAGE VISAKHAPATNAM (India) -
530040 India Visakhapatnam ANDHRA PRADESH
9177 747 328
drkrambaburesearch@ gmail.com
Dr Aashish Reddy Bande
Yashoda Hospitals
Yashoda Hospitals
Behind Hari Hara kala Bhawan SP Road Secunderabad, Hyderabad Telangana - 500003 India Hyderabad TELANGANA
Institutional Ethics Committee Visakha Institute of Medical Sciences
Approved
Institutional Ethics Committee Yashoda Academy of Medical Education and Research
Approved
Institutional Ethics Committee, Neelima Hospitals
Approved
Kakatiya Institutional Ethics Committee
Approved
latha super specialities hospital ethics committee
Approved
Malla Reddy Medical College for Women Institutional Ethics Committee
Approved
O & P Institutional Ethics Committee
Approved
Prakriya Hospitals Institutional Ethics Committee
Approved
Saveetha Medical College and Hospital Institutional Ethics Committee (SMCH-IEC)
Approved
Shree Giriraj Hospital Research Ethics Committee
Approved
SMVMCH-Ethics Committee
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
Intervention
GEN1501
Dose: The starting dose will be 10 Units. During the active intervention period, the subject will continue to receive Basal Insulin Glargine doses as started post randomization up to 24-weeks. The Insulin dosages and frequency will be adjusted every 3 days by 2 IU till the Fasting Blood Glucose value is lower than or equal to 120 mg/dl is achieved, up to a maximum dose of 100 Units by the investigator post discussion with the subject as per individual metabolic needs, SMBG results and desired goal of glucose values (per investigator opinion and individualized Insulin regimen of the subject) without increasing the risk of hypoglycemia.
Administration: Subcutaneous Injection to the abdominal wall, thigh, upper arm, or buttock; Basal Insulin at Bedtime. The subjects will be advised for alternating the sites of drug administration.
Comparator Agent
Lantus®
Dose: The starting dose will be 10 Units. During the active intervention period, the subject will continue to receive Basal Insulin Glargine doses from visit 2 to visit 16 (for 24 weeks). The Insulin dosages and frequency will be adjusted every 3 days by 2 Units till the Fasting Blood Glucose value is lower than or equal to 120 mg/dl is achieved, up to a maximum dose of 100 Units by the investigator post discussion with the subject as per individual metabolic needs, SMBG results and desired goal of glucose values (per investigator opinion and individualized Insulin regimen of the subject) without increasing the risk of hypoglycemia.
Administration: Subcutaneous Injection to the abdominal wall, thigh, upper arm, or buttock; Basal Insulin at Bedtime. The subjects will be advised for alternating the sites of drug administration. Time of IP administration to be at bedtime, same time every day.
Inclusion Criteria
Age From
18.00 Year(s)
Age To
65.00 Year(s)
Gender
Both
Details
1. Willing to give informed consent.
2. Age: between 18-65 years, both inclusive.
3. Insulin- naïve male or female subjects with type 2 diabetes mellitus, as per WHO Criteria 2006 [fasting plasma glucose ≥ 7.0mmol/l (126mg/dl) or 2–h plasma glucose ≥ 11.1mmol/l (200mg/dl)].
4. Established diagnosis of type 2 diabetes for more than one year.
5. On oral antidiabetic therapy [≥ two drugs- AGI (α-Glucosidase inhibitors), DPP-4 (Dipeptidyl peptidase-4) inhibitors, MEG (Meglitinides), MET (metformin), SU (Sulfonylureas), GLP1-RA (Glucagon-like peptide-1 receptor agonists)] stable doses, for at least 12 weeks prior to study entry.
6. Stable weight, with no more than 5 kg gain or loss, in the 3 months prior to screening.
7. Body Mass Index 18 to 35 Kg/m2.
8. Glycosylated hemoglobin - HbA1C ≥ 7.0 and ≤ 10.0% and stratification criteria ≤ 8.5% and > 8.5%.
9. Women of child-bearing potential willing to use an effective method of contraception.
10. Ability and willingness to perform self-monitored blood glucose (SMBG).
11. Monitoring using a blood glucose meter and to use a subject diary.
12. Ability to self-administer Insulin glargine by subcutaneous injection, upon training by site personnel.
13. Haemoglobin level of ≥9.0 g/dL.
14. Be able and willing to adhere to the protocol requirements.
15. Be receptive to diabetes education.
ExclusionCriteria
Details
1. Type 1 diabetes mellitus
2. Type 2 diabetic subjects on Thiazolidinedione (TZD) therapy
3. Used glucagon-like peptide 1 (GLP-1) agonist, thiazolidinediones (TZDs) within the previous 90 days.
4. More than one episode of severe hypoglycemia defined as an event requiring assistance of another person to actively administer carbohydrate, glucagon, or other resuscitative actions, within 6 months prior to study entry
5. An episode of moderate to severe Diabetic ketoacidosis in the last three months prior to screening needing inpatient or outpatient care.
6. Clinically significant abnormal hepatic (e.g., AST or ALT greater than 2.5x ULN, or total bilirubin greater than 1.5x ULN) or renal function lab tests (e.g., creatinine greater than 1.25x ULN) suggestive of hepatic or renal impairment.
7. History of renal transplant.
8. Severe peripheral vascular disease which has resulted in amputation, chronic foot ulcer, claudication or absent pulses.
9. Known history of autonomic neuropathy. Pregnancy or women intending to become pregnant during the trial period and Breast feeding.
10. Blood donation within the last 30 days.
11. Subjects with history of alcohol or drug abuse or smokers.
12. History of cancer in the last 5 years.
13. Treatment by another Investigational Medicinal Product during the 6 months prior to screening.
14. History of hypersensitivity to the trial drugs or to drugs with a similar chemical structure or excipients.
15. History of severe or multiple allergies.
16. Any condition which requires administration of systemic corticosteroid in the last 2 weeks prior to screening or any condition which requires chronic treatment with systemic corticosteroids.
17. Current significant cardiovascular, respiratory, gastrointestinal diseases.
18. Major surgical procedure within 6 months of screening.
19. Subjects with history of HIV, Hepatitis B and/or Hepatitis C.
20. Not suitable to participate in the study in the opinion of the Investigator including an existing physical or mental condition that prevents compliance with the protocol.
21. Exposed to a biosimilar insulin glargine within the previous 90 days.
22. Excessive insulin resistance at study entry (total insulin dose ≥1.5 U/kg).
23. Known hypersensitivity or allergy to insulin glargine or its excipients OR history of significant allergic drug reactions.
24. Receiving chronic (lasting longer than 14 consecutive days) systemic glucocorticoid therapy at pharmacological doses (excluding topical, intra-articular, intra-ocular, or inhalational preparations and physiologic replacement doses for adrenal deficiency) or had received such therapy within 4 weeks prior to screening.
25. Inadequately treated hypertension (systolic ≥150 mm Hg or diastolic ≥100 mm Hg).
26. Evidence of hypokalemia (serum potassium < 3.5 mmol/L at screening).
27. Congestive heart failure (New York Heart Association [NYHA] class III & class IV), angina, myocardial infarction, cerebrovascular accident, coronary/peripheral artery bypass graft surgery, transient ischemic attack, or pulmonary embolism or any other established major cardiovascular disease prior to screening.
28. Any chronic disorder or severe disease which, in the opinion of the investigator, might jeopardize patient’s safety or compliance with the protocol.
29. Breastfeeding, pregnant, or intended to become pregnant during the course of the study, or were sexually active women of childbearing potential not actively practicing birth control using a method deemed to be medically acceptable by the investigator.
30. Undergone a surgical procedure within 4 weeks prior to signing informed consent or has planned major surgery during the study.
31. Clinically significant laboratory values at screening which in the judgement of Investigator can interfere with study assessments or pose safety risk to the subject.
32. If participated in any other clinical trial within the last 6 months before the current study or concurrently enrolled/scheduled to be enrolled in any other type of medical research during the current study period.
Method of Generating Random Sequence
Computer generated randomization
Method of Concealment
Centralized
Blinding/Masking
Outcome Assessor Blinded
Primary Outcome
Outcome
TimePoints
The change of Glycosylated Hemoglobin (HbA1C) from baseline to the time period
12 weeks
Secondary Outcome
Outcome
TimePoints
The change of Glycosylated Hemoglobin (HbA1C) from baseline to the time period.
24 weeks
The proportion of subjects reaching glycemic target (HbA1C 7%) shall be evaluated.
Week 12 & 24
Change in Fasting Blood Glucose from baseline
-
Change in Postprandial Blood Glucose from baseline.
-
The change in body weight of the subjects in either arms shall be calculated.
at the end of 24 weeks
Mean change from baseline of self-monitored blood glucose (SMBG) levels
week 12 & 24 in both the arms
Target Sample Size
Total Sample Size="240" Sample Size from India="240" Final Enrollment numbers achieved (Total)= "240" Final Enrollment numbers achieved (India)="240"