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

This study is not yet open for participant recruitment. (see Contacts and Locations)
Verified May 2014 by Wockhardt
Sponsor:
Information provided by (Responsible Party):
Wockhardt
ClinicalTrials.gov Identifier:
NCT01352663
First received: May 9, 2011
Last updated: May 28, 2014
Last verified: May 2014
  Purpose

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.


Condition Intervention Phase
Type I Diabetes
Biological: Wockhardt's Insulin Analogue (Recomb)
Biological: Lantus®
Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: An Open Label, Randomized Comparison of Wockhardt's Recombinant Insulin Analogue With Innovator's Glargine in Type 1 Diabetic Patients.

Resource links provided by NLM:


Further study details as provided by Wockhardt:

Primary Outcome Measures:
  • Change in HbAlc from baseline till the end of treatment period. [ Time Frame: 12 months ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Percentage change in immunogenic response. [ Time Frame: 12 months ] [ Designated as safety issue: No ]
    Evaluating antibodies titre.


Estimated Enrollment: 500
Study Start Date: May 2015
Estimated Study Completion Date: January 2017
Estimated Primary Completion Date: July 2016 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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.

Detailed Description:

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

  Eligibility

Ages Eligible for Study:   18 Years to 55 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01352663

Contacts
Contact: Dr Mushtaque Mastim +91-22-26596085 ext 6425 mmastim@wockhardt.com
Contact: Dr Manishkumar Shah, PhD +91-22-26596085 ext 6503 mshah@wockhardt.com

Sponsors and Collaborators
Wockhardt
Investigators
Study Director: Dr Ashima Bhatia, M.D. Wockhardt
  More Information

No publications provided

Responsible Party: Wockhardt
ClinicalTrials.gov Identifier: NCT01352663     History of Changes
Other Study ID Numbers: P3-GLR-IMSFDA-01
Study First Received: May 9, 2011
Last Updated: May 28, 2014
Health Authority: United States: Food and Drug Administration
India: Drugs Controller General of India

Keywords provided by Wockhardt:
Type I Diabetes
Wockhardt
Insulin Analogue

Additional relevant MeSH terms:
Diabetes Mellitus
Diabetes Mellitus, Type 1
Glucose Metabolism Disorders
Metabolic Diseases
Endocrine System Diseases
Autoimmune Diseases
Immune System Diseases
Insulin, Globin Zinc
Glargine
Insulin
Hypoglycemic Agents
Physiological Effects of Drugs
Pharmacologic Actions

ClinicalTrials.gov processed this record on August 28, 2014