Comparative Glucose Clamp Study of Wockhardt's Recombinant Insulin Analog Glargine(Glaritus) With Lantus in Type1 Diabetes

The purpose of this study is to test for bioequivalence based on the pharmacokinetic
parameter AUC INS-GLR 0-24h and on pharmacodynamic parameter AUC GIR 0-24h between the two
long-acting insulin glargine formulations, Lantus® and Wockhardt's Glaritus® in subjects
with type1 diabetes as well as assessing safety and local tolerability of the two insulin
preparations.

Inclusion Criteria:

1. Male or female subjects with type 1 diabetes ≥12 months.

2. HbA1c ≤9% by local laboratory analysis (one retest within a week is permitted with
the result of the last test being conclusive).

3. Age ≥18 and ≤60 years.

4. Considered generally healthy upon completion of medical history, physical examination
and biochemical investigations as judged by the Investigator.

5. Signed and dated informed consent obtained before any trial-related activities.
(Trial-related activities are any procedure that would not have been performed during
normal management of the subject).

Exclusion Criteria:

1. Previous participation in this trial, or participation in other clinical trials
within the last 30 days.

2. Pregnant, breast-feeding or the intention of becoming pregnant or not using adequate
contraceptive measures (e.g. intrauterine device (IUD) that has been in place for at
least 3 months, or sterilization, or the oral contraceptive pill, which should have
been taken without difficulty for at least 3 months, an approved hormonal implant or
double barrier method including male condoms used plus spermicide, diaphragm with
spermicide plus male condom, cap with spermicide plus male condom).

3. History of any illness that, in the opinion of the Investigator, might confound the
results of the trial or pose risk in administering the trial drug to the subject. In
particular, subjects with significant cardiovascular disease, anemia (hemoglobin
below the lower limit of normal) or hemoglobinopathy will not be allowed to enter the
trial.

4. Cardiac problems defined as decompensated heart failure (New York Heart Association
(NYHA) class III and IV) at any time and/or angina pectoris within the last 12 months
and/or acute myocardial infarction at any time.

5. Clinically significant abnormal ECG at screening, as judged by the Investigator.

6. History of alcohol or drug abuse in the past five years.

7. Any positive reaction of drug abuse.

8. Hepatitis B or C or HIV positive.

9. Mental incapacity, unwillingness or language barriers precluding adequate
understanding or cooperation.

10. History of multiple and/or severe allergies to drugs or foods or a history of severe
anaphylactic reaction.

11. Regular cigarette smoker, defined as smoking >1 pack/day and unable to refrain from
smoking during the in house period.

12. Known or suspected allergy to trial product or related products.

13. Any disease or condition that, in the opinion of the Investigator, would represent an
unacceptable risk for the subject's safety.