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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

WITHDRAWN

Clinical Phase

PHASE3

Study Classification

INTERVENTIONAL

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.

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Detailed Description

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

Conditions

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Type I Diabetes

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Wockhardt's Insulin Analogue (Recomb)

Basal bolus Wockhardt's Recombinant Insulin Analogue to be injected subcutaneously.

Group Type EXPERIMENTAL

Wockhardt's Insulin Analogue (Recomb)

Intervention Type BIOLOGICAL

Basal bolus Wockhardt's Recombinant Insulin Analogue to be injected subcutaneously.

Lantus®

Basal bolus Insulin analog glargine (Lantus®) to be injected subcutaneously.

Group Type ACTIVE_COMPARATOR

Lantus®

Intervention Type BIOLOGICAL

Basal bolus Insulin analog glargine (Lantus®) to be injected subcutaneously.

Interventions

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Wockhardt's Insulin Analogue (Recomb)

Basal bolus Wockhardt's Recombinant Insulin Analogue to be injected subcutaneously.

Intervention Type BIOLOGICAL

Lantus®

Basal bolus Insulin analog glargine (Lantus®) to be injected subcutaneously.

Intervention Type BIOLOGICAL

Eligibility Criteria

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Inclusion Criteria

1. Patients who have been pre-diagnosed as cases of type-1 diabetes for a period not less than 1 year
2. Male or Female Patients \>= 18 and =\< 55 years of age.
3. Patients with BMI of 18.0 to 30.0 kg/m2
4. Patients who are cooperative, reliable, and agree to have regular injections of insulin and are willing to comply with protocol procedures.

Exclusion Criteria

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

Minimum Eligible Age

18 Years

Maximum Eligible Age

55 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No