A Prospective Multi center Randomized Double blind Parallel group Active controlled Phase III Study to Compare the Efficacy Safety and Immunogenicity of Regenix Biosciences Limited Insulin 30/70 with Eli Lilly s bacteria based Human Insulin Basal Bolus Humulin 30/70

Phase 3

• Conditions: Health Condition 1: E08-E13- Diabetes mellitus

• Registration Number: CTRI/2024/02/063318
• Lead Sponsor: Regenix Biosciences Limited

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Last Update Posted: 27 May 2024

Recruitment & Eligibility

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

Inclusion Criteria

1 Patients who understand and agrees to comply with the study procedure and provide written informed consent 2 Patients who have been diagnosed as cases of diabetes Fasting C peptide less than 0.2 nmol per L and have been on a stable dose of insulin for at least 3 months prior to inclusion in the trial A stable dose is defined as the dose staying within +/- 10% 3 Male or Female Patients between 18 to 65 years of age 4 Patients with body mass index BMI 18.0 to 35.0 kg per m2 5 Patients with glycosylated hemoglobin HbA1c levels between 7.5 and 10.0% both inclusive 6 Patients who are cooperative reliable and agree to have regular injections of insulin and are willing to comply with protocol procedures 7 Female patients non pregnant and non lactating with adequate protection from conception Females of childbearing potential must agree to use an acceptable method of birth control including barrier method contraceptives or intrauterine device Women with history of bilateral tubal ligation women who have undergone total hysterectomy or women who are two years post-menopausal are also eligible 8 Ability to use the self glucose monitoring device and self inject insulin

Exclusion Criteria

1 Patient who is pregnant or is currently breast feeding 2 Patient with compromised hepatic or renal function, as shown by but not limited to baseline AST or ALT 3 times the upper limit of normal range serum creatinine 2.0 mg per dl and or BUN 30 mg per dl respectively Abnormal findings should be discussed with the medical monitor prior to the patients entry

3 Patient who has been treated with other investigational agent or devices within the previous 30 days has planned use of investigational drugs or devices or has been previously randomized in this trial 4 Patient with history or evidence of allergy to insulin preparations 5 Patient with history or evidence of recurrent severe hypoglycemia 6 Patient whose requirement for total daily dose of insulin is 1.4 units per kg 7 Patient who has received Regenix insulin 30/70 or Eli Lillys Insulin Humulin 30/70 for the previous one year 8 Patients with serum anti insulin antibody AIA level above 20 micro U per ml 9 Patient who has received any insulin of animal origin during the last 3 years 10 Patients who are currently receiving or have received within the last year any immune modulators medications including corticosteroids that would possibly modify antibody generation either at the enrollment or during the course of the study Topical ophthalmic intra articular nasal spray corticosteroids will be allowed 11 Patients who are Hepatitis B or C or HIV positive 12 Patients who have undergone pancreatectomy or pancreas/islet cell transplant 13 Patients unlikely to comply with the study protocol eg unable to return periodically for subsequent visits 14 Patient with history or evidence of active severe proliferative retinopathy nephropathy and or neuropathy significant cardiovascular disease anemia or hemoglobinopathy hypothyroidism alcohol or drug abuse or any other medical condition that in the opinion of Investigator can interfere with the study 15 Patients who are judged by the investigator as inappropriate to participate in the study for any reason other than those mentioned above.

Study & Design

• Study Type: Interventional
• Study Design: Not specified