A Phase III clinical study to evaluate efficacy and safety of GeneSys Insulin Glargine

Phase 3

• Conditions: Health Condition 1: E119- Type 2 diabetes mellitus without complications

• Registration Number: CTRI/2023/03/050804
• Lead Sponsor: GeneSys Biologics Pvt. Ltd.

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Last Update Posted: 19 December 2023

Recruitment & Eligibility

• Status: ot Yet Recruiting
• Sex: Not specified
• Target Recruitment: 0

Inclusion Criteria

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 (a-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.

Exclusion Criteria

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. B

Study & Design

• Study Type: Interventional
• Study Design: Not specified