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

Primary Purpose

Type I Diabetes

Status

Withdrawn

Phase

Phase 3

Locations

Study Type

Interventional

Intervention

Wockhardt's Insulin Analogue (Recomb)

Lantus®

About this trial

This is an interventional treatment trial for Type I Diabetes focused on measuring Type I Diabetes, Wockhardt, Insulin Analogue

Eligibility Criteria

18 Years - 55 Years (Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

Wockhardt's Insulin Analogue (Recomb)

Lantus®

Arm Description

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

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

Outcomes

Primary Outcome Measures

Change in HbAlc from baseline till the end of treatment period.

Secondary Outcome Measures

Percentage change in immunogenic response.

Evaluating antibodies titre.

Full Information

NCT ID

NCT01352663

First Posted

May 9, 2011

Last Updated

October 3, 2019

Sponsor

Wockhardt

1. Study Identification

Unique Protocol Identification Number

NCT01352663

Brief Title

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

Official Title

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

Study Type

Interventional

2. Study Status

Record Verification Date

October 2019

Overall Recruitment Status

Withdrawn

Why Stopped

Business strategy decision

Study Start Date

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Primary Completion Date

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Study Completion Date

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3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

Wockhardt

4. Oversight

Data Monitoring Committee

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Type I Diabetes

Keywords

Type I Diabetes, Wockhardt, Insulin Analogue

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 3

Interventional Study Model

Parallel Assignment

Masking

None (Open Label)

Allocation

Randomized

Enrollment

0 (Actual)

8. Arms, Groups, and Interventions

Arm Title

Wockhardt's Insulin Analogue (Recomb)

Arm Type

Experimental

Arm Description

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

Arm Title

Lantus®

Arm Type

Active Comparator

Arm Description

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

Intervention Type

Biological

Intervention Name(s)

Wockhardt's Insulin Analogue (Recomb)

Intervention Description

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

Intervention Type

Biological

Intervention Name(s)

Lantus®

Intervention Description

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

Primary Outcome Measure Information:

Title

Change in HbAlc from baseline till the end of treatment period.

Time Frame

12 months

Secondary Outcome Measure Information:

Title

Percentage change in immunogenic response.

Description

Evaluating antibodies titre.

Time Frame

12 months

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Maximum Age & Unit of Time

55 Years

Accepts Healthy Volunteers

Eligibility Criteria

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.

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Dr Ashima Bhatia, M.D.

Organizational Affiliation

Wockhardt

Official's Role

Study Director

12. IPD Sharing Statement

Learn more about this trial

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

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