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

Type I Diabetes Clinical Trial

Official title:

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

Clinical Trial Details — Status: Withdrawn

Administrative data

• NCT number: NCT01352663
• Other study ID #: P3-GLR-IMSFDA-01
• Status: Withdrawn
• Phase: Phase 3

Study information

• Verified date: October 2019
• Source: Wockhardt
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Description:

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

Recruitment information / eligibility

• Status: Withdrawn
• Enrollment: 0
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 55 Years

Eligibility

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.

Related Conditions & MeSH terms

• Diabetes Mellitus, Type 1
• Type I Diabetes

Intervention

Biological:
• Wockhardt's Insulin Analogue (Recomb)
Basal bolus Wockhardt's Recombinant Insulin Analogue to be injected subcutaneously.
• Lantus®
Basal bolus Insulin analog glargine (Lantus®) to be injected subcutaneously.

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Wockhardt

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Change in HbAlc from baseline till the end of treatment period.		12 months
Secondary	Percentage change in immunogenic response.	Evaluating antibodies titre.	12 months