A Prospective Multicenter Randomized Double blind Parallel group Active controlled Phase III Study to Compare the Efficacy Safety and Immunogenicity of Regenix Biosciences Limited India Insulin Glargine 100 units mL U100 with Lantus of Sanofi aventis India
- Conditions
- Health Condition 1: E08-E13- Diabetes mellitus
- Registration Number
- CTRI/2023/10/059222
- Lead Sponsor
- Regenix Biosciences Limited
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Open to Recruitment
- Sex
- Not specified
- Target Recruitment
- 0
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/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/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.
Patients will not be allowed to enter the study if they meet any of the following 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/dl and/or BUN 30 mg/dl, respectively. Abnormal findings should be discussed with the medical monitor prior to the patient’s
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/kg
7. Patient who has received Insulin Glargine or Sanofi-aventis’s Lantus (Insulin Glargine), for the previous one year
8. Patients with serum anti-insulin antibody (AIA) level above 20 micro U/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 e.g., 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
- Primary Outcome Measures
Name Time Method
- Secondary Outcome Measures
Name Time Method