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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

May 9, 2011
May 28, 2014
May 2015
July 2016   (final data collection date for primary outcome measure)
Change in HbAlc from baseline till the end of treatment period. [ Time Frame: 12 months ] [ Designated as safety issue: No ]
Change in HbAlc from baseline to 6 months of treatment between Glaritus and Lantus(as surrogate indicator of change in insulin antibodies titers between the two treatment arms). [ Time Frame: 6 months ] [ Designated as safety issue: No ]
Complete list of historical versions of study NCT01352663 on ClinicalTrials.gov Archive Site
Percentage change in immunogenic response. [ Time Frame: 12 months ] [ Designated as safety issue: No ]
Evaluating antibodies titre.
  • Change in HbA1c, anti insulin antibodies (AIA) and insulin neutralizing antibodies (INA). [ Time Frame: 6 months ] [ Designated as safety issue: No ]
    Correlating HbA1c with AIA and INA.Insulin dose will be used as a covariate
  • The percent change at 6 months from the baseline in the level of serum AIA & INA in the Glaritus arm with percent change in the level of serum AIA & INA in the Lantus arm. [ Time Frame: 6 months ] [ Designated as safety issue: No ]
  • The change in the glargine dose between Glaritus arm with Lantus arm after the 3rd and 6th month [ Time Frame: 3 months,6 months ] [ Designated as safety issue: No ]
  • The percent change at 12 months from the baseline in the level of serum AIA & INA in the Glaritus arm [ Time Frame: 12 months ] [ Designated as safety issue: No ]
  • Change in HbAlc from baseline to 12 months of treatment in Glaritus arm [ Time Frame: 12 months ] [ Designated as safety issue: No ]
  • In both the groups, the correlation of the immunogenicity with hypoglycemia, local allergic reactions and systemic allergic reactions will be evaluated. [ Time Frame: 3 months, 6 months, 9 months,12 months ] [ Designated as safety issue: Yes ]
    Immunogenicity is measured as percentage change in serum AIA
Not Provided
Not Provided
 
Immunogenicity Safety Study of Wockhardt's Recombinant Insulin Analogue in Type 1 Diabetic Patients
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.

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

Interventional
Phase 3
Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Type I Diabetes
  • Biological: Wockhardt's Insulin Analogue (Recomb)
    Basal bolus Wockhardt's Recombinant Insulin Analogue to be injected subcutaneously.
  • Biological: Lantus®
    Basal bolus Insulin analog glargine (Lantus®) to be injected subcutaneously.
  • Experimental: Wockhardt's Insulin Analogue (Recomb)
    Basal bolus Wockhardt's Recombinant Insulin Analogue to be injected subcutaneously.
    Intervention: Biological: Wockhardt's Insulin Analogue (Recomb)
  • Active Comparator: Lantus®
    Basal bolus Insulin analog glargine (Lantus®) to be injected subcutaneously.
    Intervention: Biological: Lantus®
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Not yet recruiting
500
January 2017
July 2016   (final data collection date for primary outcome measure)

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.
Both
18 Years to 55 Years
No
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
Not Provided
 
NCT01352663
P3-GLR-IMSFDA-01
No
Wockhardt
Wockhardt
Not Provided
Study Director: Dr Ashima Bhatia, M.D. Wockhardt
Wockhardt
May 2014

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP