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

Wockhardt

Status and phase: Withdrawn; Phase 3

Conditions: Type I Diabetes

Treatments: Biological: Lantus®; Biological: Wockhardt's Insulin Analogue (Recomb)

Study type: Interventional

Funder types: Industry

Identifiers

NCT01352663

P3-GLR-IMSFDA-01

Details and patient eligibility

About

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.

Full description

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

Sex: All

Ages: 18 to 55 years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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0 participants in 2 patient groups

Wockhardt's Insulin Analogue (Recomb)

Experimental group

Description:

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

Treatment:

Biological: Wockhardt's Insulin Analogue (Recomb)

Lantus®

Active Comparator group

Description:

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

Treatment:

Biological: Lantus®