Immunogenicity Study of Wockhardt's Insulin Lispro/Lispro Mix Basal Bolus Regimen in Type 1 Diabetics

Exclusion Criteria

• •1. Females who are pregnant or lactating, or not practicing adequate contraception.
• •2. A Patient with compromised hepatic or renal function
• •3. A Patient who is an employee of the Investigator, or a patient who has a direct involvement with the trial or other trials under the direction of the Investigator.
• •4. A 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. A Patient with history or evidence of allergy to insulin preparations.
• •6. A Patients who is currently receiving or has received, within the last year, any immunomodulator medications.
• •7. Patients unlikely to comply with the study protocol e.g. unable to return periodically for subsequent visits.
• •8. Patients who are judged by the investigator as inappropriate to participate in the study for any reason other than those mentioned.