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

October 3, 2019 updated by: Wockhardt

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

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.

Study Overview

Status

Withdrawn

Conditions

Intervention / Treatment

Detailed Description

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

Study Type

Interventional

Phase

  • Phase 3

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 55 years (Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Wockhardt's Insulin Analogue (Recomb)
Basal bolus Wockhardt's Recombinant Insulin Analogue to be injected subcutaneously.
Biological: Wockhardt's Insulin Analogue (Recomb)
Basal bolus Wockhardt's Recombinant Insulin Analogue to be injected subcutaneously.
Active Comparator: Lantus®
Basal bolus Insulin analog glargine (Lantus®) to be injected subcutaneously.
Biological: Lantus®
Basal bolus Insulin analog glargine (Lantus®) to be injected subcutaneously.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Change in HbAlc from baseline till the end of treatment period.
Time Frame: 12 months
12 months

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Percentage change in immunogenic response.
Time Frame: 12 months
Evaluating antibodies titre.
12 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Wockhardt

Investigators

  • Study Director: Dr Ashima Bhatia, M.D., Wockhardt

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

First Submitted

May 9, 2011

First Submitted That Met QC Criteria

May 10, 2011

First Posted (Estimate)

May 12, 2011

Study Record Updates

Last Update Posted (Actual)

October 8, 2019

Last Update Submitted That Met QC Criteria

October 3, 2019

Last Verified

October 1, 2019

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • P3-GLR-IMSFDA-01

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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