Immunosafety Study of Recombinant Human Insulins in Type 1 Diabetics

Inclusion Criteria:

1. Subjects who understand the nature of the study and are willing to provide written
informed consent.

2. Subjects who have been pre-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. Subjects who have been on a stable regimen of recombinant human insulin or analogs
for at least 3 months prior to randomization. (A stable regimen is defined as the
dose within +/- 10%).

4. Male or female subjects ≥ 18 and < 55 years of age.

5. Subjects with body mass index (BMI) of ≥18.0 to < 35.0 kg/m2

6. Subjects with glycosylated hemoglobin (HbA1c) levels between ≥6.5 and < 9.5%

7. Subjects who are cooperative, reliable, and agree to have regular injections of
insulin and are willing to comply with protocol procedures.

8. Female subjects who are not pregnant and non-lactating with adequate protection from
conception and fulfilling one of the following criteria are also eligible if within ≥
18 and < 55 years age limits:

1. Women of childbearing potential on an acceptable method of birth control
(including but not limited to barrier-method, contraceptives, or intrauterine
device)

2. Women with history of bilateral tubal ligation,

3. Women who have undergone total hysterectomy

4. Women who are two years post-menopausal

9. Subjects who are able to use the self glucose-monitoring device and to self inject
insulin.

Exclusion Criteria:

1. Female subjects who are pregnant (as confirmed by a positive urine and serum β-HCG)
or are currently breast-feeding.

2. Compromised hepatic or renal function, as shown by but not limited to:

i.Baseline AST or ALT >3 times the upper limit of normal range, and/or ii.Serum
Creatinine >2.0 mg/dl and/or iii.BUN >30 mg/dl Abnormal laboratory findings will be
discussed with the medical monitor prior to the subject's entry.

3. Employee of Investigator or have direct involvement with trial or other trials under
the direction of Investigator.

4. Those treated with other investigational agents or devices within previous 30 days,
from screening, have planned use of an investigational drug or device, or have been
previously randomized in this trial.

5. History or evidence of allergy to insulin preparations.

6. History or evidence of severe hypoglycemia (severe hypoglycemic episode defined as
the subject required glucose, glucagon, orange juice etc administered by a second
person)

7. Requirement for total daily dose of insulin is >1.4 units/kg

8. Who have received Wockhardt's (Wosulin) or Novo Nordisk's Insulin (Novolin® R,
Novolin® N, Novolin® 70/30, in US and Actrapid® Insulatard®, and Mixtard® in India)
during the previous one year.

9. Serum AIA level > 20 microU/ml.

10. Receipt of any insulin of an animal origin during the last 3 years.

11. 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. Hepatitis B or Hepatitis C or HIV positive.

13. Oral hypoglycaemic agent within 4 weeks prior to signing the consent form.

14. Who have undergone pancreatectomy or pancreas/islet cell transplant.

15. Unlikely to comply with the study protocol e.g. unable to return periodically for
subsequent visits.

16. History or evidence of active severe proliferative retinopathy, nephropathy and/or
neuropathy significant cardiovascular disease, anemia or hemoglobinopathy,
uncontrolled hypothyroidism or uncontrolled hyperthyroidism, alcohol or drug abuse or
any other medical condition that in the opinion of Investigator can interfere with
the study.

17. Judged by the investigator as inappropriate to participate in the study for any
reason other than those mentioned above.