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

• Percentage change in the immunogenic response [ Time Frame: 6 months ] [ Designated as safety issue: Yes ]
• Correlation of the immunogenicity with hypoglycemia [ Time Frame: 12 months ] [ Designated as safety issue: Yes ]

• Percentage change in the immunogenic response (measured as percentage change in AIA and INA) from baseline to 6 months of treatment in Listro™ and Humalog® arms. [ Time Frame: 6 months ] [ Designated as safety issue: Yes ]
• The change in the Lispro dose in the Listro™ arm and Humalog® arm [ Time Frame: 3 months, 6 months ] [ Designated as safety issue: No ]

  Patients will be grouped as

  • No change in Lispro dose (+/- 10% of the dose required at baseline)
  • >10% increase in Lispro dose
  • >10% decrease in Lispro dose Glycated hemoglobin levels and the number of hypoglycemic episodes will be the covariates for this analysis.
• The absolute and percentage change in HbAlc from baseline to 12 months of treatment in Listro™ arm. [ Time Frame: 12 months ] [ Designated as safety issue: No ]
• The percent change at 12 months from the baseline in the level of AIA and INA in the Listro™ arm. [ Time Frame: 12 months ] [ Designated as safety issue: Yes ]
• In both the groups, the correlation of the immunogenicity (measured as percentage change in AIA and INA) with hypoglycemia, local allergic reactions and systemic allergic reactions [ Time Frame: 12 months ] [ Designated as safety issue: Yes ]
• Correlation between HbA1c percent change from baseline to 6 months of treatment and percent change in insulin neutralizing antibodies with Lispro dose as covariate. [ Time Frame: 6 months ] [ Designated as safety issue: No ]

This is a randomized, parallel group comparison of the immunogenicity safety of Wockhardt's Insulin analogue Lispro and lispro Mix with Eli Lilly's Insulin analogue Humalog® and Humalog® Mix in patients with Type 1 Diabetes Mellitus

To evaluate and compare the Immunogenicity safety of Wockhardt's Insulin analogue Lispro and lispro Mix with Eli Lilly's Insulin analogue Humalog® and Humalog® Mix in Type I Diabetic patients.

• Biological: Insulin Lispro

  a. Lispro and Lispro Mix® 75/25 / Lispro Mix 50/50

  The drugs would be administered subcutaneously

• Biological: Insulin Lispro

  Humalog® and Humalog® Mix75/25 /Humalog® Mix 50/50

  The drugs would be administered subcutaneously

• Experimental: Lispro arm
  Lispro and Lispro Mix 75/25 /Lispro Mix 50/50
  Intervention: Biological: Insulin Lispro
• Active Comparator: Humalog® arm
  Humalog® and Humalog® Mix75/25 / Humalog® Mix50/50
  Intervention: Biological: Insulin Lispro

Inclusion Criteria:

1. Patients who understand the nature of the study and are willing to provide written informed consent.
2. Patients who have been pre-diagnosed as cases of type-1 diabetes for a period not less than 1 year
3. Male or Female Patients ≥ 18 and < 55 years of age.
4. Patients with body mass index (BMI) of 18.0 to 30.0 kg/m2
5. Patients who are cooperative, reliable, and agree to have regular injections of insulin and are willing to comply with protocol procedures.
6. Ability to use the self glucose-monitoring device and to self inject insulin.

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.