Immunogenicity Safety Study of Wockhardt's Recombinant Insulin Analogue in Type 1 Diabetic Patients

Study Overview
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Brief Summary
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This is an open label, randomized, parallel group comparison of the immunogenicity safety of Wockhardt's Recombinant Insulin Analogue with the innovator's Glargine in Type 1 diabetics patients.

Detailed Description
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To evaluate and compare the Immunogenicity Safety of Wockhardt's Recombinant Insulin Analogue with innovator's Glargine.

Official Title
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An Open Label, Randomized Comparison of Wockhardt's Recombinant Insulin Analogue With Innovator's Glargine in Type 1 Diabetic Patients.

Conditions
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Type I Diabetes

Intervention / Treatment
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* Biological: Wockhardt's Insulin Analogue (Recomb)
* Biological: Lantus®


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: 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 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. Exclusion Criteria: A Patient who is pregnant or is currently breast-feeding. A Patient with history of severe hypoglycemia within the past year 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. Patients who are Hepatitis B or C positive on testing or have positive medical history of HIV at screening. Patients unlikely to comply with the study protocol e.g. unable to return periodically for subsequent visits.

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: Wockhardt's Insulin Analogue (Recomb)<br>Basal bolus Wockhardt's Recombinant Insulin Analogue to be injected subcutaneously. | Biological: Wockhardt's Insulin Analogue (Recomb)<br>* Basal bolus Wockhardt's Recombinant Insulin Analogue to be injected subcutaneously.<br>|
| Active Comparator: Lantus®<br>Basal bolus Insulin analog glargine (Lantus®) to be injected subcutaneously. | Biological: Lantus®<br>* Basal bolus Insulin analog glargine (Lantus®) to be injected subcutaneously.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in HbAlc from baseline till the end of treatment period. |  | 12 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Percentage change in immunogenic response. | Evaluating antibodies titre. | 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, Insulin Analogue