Immunogenicity and Safety study of Wockhardts Human Insulin(Wosulin R, Wosulin N and Wosulin 70/30)} with the Novo Nordisks yeast based Human Insulin marketed in United States (Novolin® R, Novolin® N and Novolin® 70/30) in Type 1 Diabetics.
- Conditions
- Health Condition 1: null- Type 1 Diabetic
- Registration Number
- CTRI/2011/10/002042
- Lead Sponsor
- Wockhardt Limited
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Completed
- Sex
- Not specified
- Target Recruitment
- 242
Patients must meet all of the following criteria:
1.Patients who understand the nature of the study and provide written informed consent.
2.Patients who have been diagnosed as cases of type-1 diabetes (Fasting C-peptide 0.5 nmol/L) and have been on an insulin regimen for at least 12 months prior to inclusion in the trial.
3.Patients who have been on a stable regimen of insulin for at least 3 months prior to randomization. A stable regimen is defined as the dose staying within +/- 10%.
4.Male or Female Patients 18 and 45 years of age
5.Patients with body mass index (BMI) 18.0 to 35.0 kg/m2
6.Patients with glycosylated hemoglobin (HbA1c) levels between 7.0 and 9.5%
7.Patients who are cooperative, reliable, and agree to have regular injections of insulin and are willing to comply with protocol procedures.
8.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 (if within 18 and 45 years age limits).
9.Ability to use the self glucose-monitoring device and self inject insulin.
Patients who meet ANY of the following exclusion criteria at screening or baseline will NOT be eligible for enrolment:
1.Patient who is pregnant (as confirmed by a positive HCG test/ serum â?HCG) 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 is an employee of the Investigator or the Institution, or a patient who has direct involvement with the trial or other trials under the direction of the Investigator.
4.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.
5.Patient with history or evidence of allergy to insulin preparations.
6.Patient with history or evidence of recurrent severe hypoglycemia
7.Patient whose requirement for total daily dose of insulin is 1.4 units/kg
8.Patient who has received Wockhardt?s (Wosulin) or Novo Nordisk?s Insulin (Novolin® R, Novolin® N, Novolin® 70/30, for the previous one year
9.Patients with serum AIA level above 20 microU/ml.
10.Patient who has received any insulin of animal origin during the last 3 years.
11.Patients who are currently receiving or have received within the last year any immunomodulators 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.
12.Patients who are Hepatitis B or C or HIV positive.
13.Patients who received an oral hypoglycaemic agent within 4 weeks prior to signing consent form.
14.Patients who have undergone pancreatectomy or pancreas/islet cell transplant
15.Patients unlikely to comply with the study protocol e.g. unable to return periodically for subsequent visits.
16.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.
17.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 Absolute change in HbAlc from baseline to 6 months of treatment between <br/ ><br>Wosulin and Novolin® USA (as surrogate indicator of change in insulin antibodies <br/ ><br>titers between the two treatment arms)Timepoint: 6 months from baseline and 12 months from baseline
- Secondary Outcome Measures
Name Time Method Correlation between the percent change in HbA1c from baseline to 6 months of <br/ ><br>treatment and percent change in anti insulin and neutralizing antibodies (AIA and <br/ ><br>INA) with absolute change in total insulin dose as covariate.Timepoint: 6 months from baseline and 12 months from baseline.