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

Phase 3

Withdrawn

• Conditions: Type I Diabetes
• Interventions: Biological: Lantus®; Biological: Wockhardt's Insulin Analogue (Recomb)

• Registration Number: NCT01352663
• Lead Sponsor: Wockhardt

Brief Summary

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

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

Study Timeline

• Study First Submitted: 2011-05-09
• Study First Submitted QC: 2011-05-10
• Study First Posted: 2011-05-12
• Status Verified: 2019-10
• Last Update Submitted: 2019-10-03
• Last Update Posted: 2019-10-08

Recruitment & Eligibility

• Status: WITHDRAWN
• Sex: All
• Target Recruitment: Not specified

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Lantus®	Lantus®	Basal bolus Insulin analog glargine (Lantus®) to be injected subcutaneously.
Wockhardt's Insulin Analogue (Recomb)	Wockhardt's Insulin Analogue (Recomb)	Basal bolus Wockhardt's Recombinant Insulin Analogue to be injected subcutaneously.

Primary Outcome Measures

Name	Time	Method
Change in HbAlc from baseline till the end of treatment period.	12 months

Secondary Outcome Measures

Name	Time	Method
Percentage change in immunogenic response.	12 months	Evaluating antibodies titre.