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

Study Overview
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Brief Summary
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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

Detailed Description
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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.

Official Title
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Comparison of the Immunogenicity of Wockhardt's Insulin Analogue Lispro and Lispro Mix With Eli Lilly's Insulin Analogue Humalog® and Humalog® Mix in Type 1 Diabetic Patients

Conditions
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Type I Diabetes

Intervention / Treatment
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* Biological: Insulin Lispro
* Biological: Insulin Lispro


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Patients who understand the nature of the study and are willing to provide written informed consent. Patients who have been pre-diagnosed as cases of type-1 diabetes for a period not less than 1 year Male or Female Patients ≥ 18 and < 55 years of age. Patients with body mass index (BMI) of 18.0 to 30.0 kg/m2 Patients who are cooperative, reliable, and agree to have regular injections of insulin and are willing to comply with protocol procedures. Ability to use the self glucose-monitoring device and to self inject insulin. Exclusion Criteria: Females who are pregnant or lactating, or not practicing adequate contraception. A Patient with compromised hepatic or renal function 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. 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. A Patient with history or evidence of allergy to insulin preparations. A Patients who is currently receiving or has received, within the last year, any immunomodulator medications. Patients unlikely to comply with the study protocol e.g. unable to return periodically for subsequent visits. Patients who are judged by the investigator as inappropriate to participate in the study for any reason other than those mentioned.

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 55 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Lispro arm<br>Lispro and Lispro Mix 75/25 /Lispro Mix 50/50 | Biological: Insulin Lispro<br>* a. Lispro and Lispro Mix® 75/25 / Lispro Mix 50/50 The drugs would be administered subcutaneously<br>|
| Active Comparator: Humalog® arm<br>Humalog® and Humalog® Mix75/25 / Humalog® Mix50/50 | Biological: Insulin Lispro<br>* Humalog® and Humalog® Mix75/25 /Humalog® Mix 50/50 The drugs would be administered subcutaneously<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in HbA1c |  | 6 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Percentage change in the immunogenic response |  | 6 months | 
| Correlation of the immunogenicity with hypoglycemia |  | 12 months | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Type I Diabetes, Wockhardt's Insulin analogue Lispro, Humalog®, Humalog Mix, Wockhardt, Biosimilar, Phase 3