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Immunogenicity Study of Wockhardt's Insulin Lispro/Lispro Mix Basal Bolus Regimen in Type 1 Diabetics

This study has been withdrawn prior to enrollment.
(Study was not initiated)
Sponsor:
Information provided by (Responsible Party):
Wockhardt
ClinicalTrials.gov Identifier:
NCT01398670
First received: July 19, 2011
Last updated: January 24, 2013
Last verified: January 2013

July 19, 2011
January 24, 2013
February 2012
March 2013   (final data collection date for primary outcome measure)
Change in HbA1c [ Time Frame: 6 months ] [ Designated as safety issue: No ]
Change in HbA1c, from baseline to 6 months of treatment between patients in Listro™ arm and Humalog® arm (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 NCT01398670 on ClinicalTrials.gov Archive Site
  • Percentage change in the immunogenic response [ Time Frame: 6 months ] [ Designated as safety issue: Yes ]
  • Correlation of the immunogenicity with hypoglycemia [ Time Frame: 12 months ] [ Designated as safety issue: Yes ]
  • Percentage change in the immunogenic response (measured as percentage change in AIA and INA) from baseline to 6 months of treatment in Listro™ and Humalog® arms. [ Time Frame: 6 months ] [ Designated as safety issue: Yes ]
  • The change in the Lispro dose in the Listro™ arm and Humalog® arm [ Time Frame: 3 months, 6 months ] [ Designated as safety issue: No ]

    Patients will be grouped as

    • No change in Lispro dose (+/- 10% of the dose required at baseline)
    • >10% increase in Lispro dose
    • >10% decrease in Lispro dose Glycated hemoglobin levels and the number of hypoglycemic episodes will be the covariates for this analysis.
  • The absolute and percentage change in HbAlc from baseline to 12 months of treatment in Listro™ arm. [ Time Frame: 12 months ] [ Designated as safety issue: No ]
  • The percent change at 12 months from the baseline in the level of AIA and INA in the Listro™ arm. [ Time Frame: 12 months ] [ Designated as safety issue: Yes ]
  • In both the groups, the correlation of the immunogenicity (measured as percentage change in AIA and INA) with hypoglycemia, local allergic reactions and systemic allergic reactions [ Time Frame: 12 months ] [ Designated as safety issue: Yes ]
  • Correlation between HbA1c percent change from baseline to 6 months of treatment and percent change in insulin neutralizing antibodies with Lispro dose as covariate. [ Time Frame: 6 months ] [ Designated as safety issue: No ]
Not Provided
Not Provided
 
Immunogenicity Study of Wockhardt's Insulin Lispro/Lispro Mix Basal Bolus Regimen in Type 1 Diabetics
Comparison of the Immunogenicity of Wockhardt's Insulin Analogue Lispro and Lispro Mix With Eli Lilly's Insulin Analogue Humalog® and Humalog® Mix in Type 1 Diabetic Patients

This is a randomized, parallel group comparison of the immunogenicity safety of Wockhardt's Insulin analogue Lispro and lispro Mix with Eli Lilly's Insulin analogue Humalog® and Humalog® Mix in patients with Type 1 Diabetes Mellitus

To evaluate and compare the Immunogenicity safety of Wockhardt's Insulin analogue Lispro and lispro Mix with Eli Lilly's Insulin analogue Humalog® and Humalog® Mix in Type I Diabetic patients.

Interventional
Phase 3
Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Type I Diabetes
  • Biological: Insulin Lispro

    a. Lispro and Lispro Mix® 75/25 / Lispro Mix 50/50

    The drugs would be administered subcutaneously

  • Biological: Insulin Lispro

    Humalog® and Humalog® Mix75/25 /Humalog® Mix 50/50

    The drugs would be administered subcutaneously

  • Experimental: Lispro arm
    Lispro and Lispro Mix 75/25 /Lispro Mix 50/50
    Intervention: Biological: Insulin Lispro
  • Active Comparator: Humalog® arm
    Humalog® and Humalog® Mix75/25 / Humalog® Mix50/50
    Intervention: Biological: Insulin Lispro
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Withdrawn
0
May 2013
March 2013   (final data collection date for primary outcome measure)

Inclusion Criteria:

  1. Patients who understand the nature of the study and are willing to provide written informed consent.
  2. Patients who have been pre-diagnosed as cases of type-1 diabetes for a period not less than 1 year
  3. Male or Female Patients ≥ 18 and < 55 years of age.
  4. Patients with body mass index (BMI) of 18.0 to 30.0 kg/m2
  5. Patients who are cooperative, reliable, and agree to have regular injections of insulin and are willing to comply with protocol procedures.
  6. Ability to use the self glucose-monitoring device and to self inject insulin.

Exclusion Criteria:

  1. Females who are pregnant or lactating, or not practicing adequate contraception.
  2. A Patient with compromised hepatic or renal function
  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. A Patient who has been treated with other investigational agent or devices within the previous 30 days, has planned use of investigational drugs or devices, or has been previously randomized in this trial.
  5. A Patient with history or evidence of allergy to insulin preparations.
  6. A Patients who is currently receiving or has received, within the last year, any immunomodulator medications.
  7. Patients unlikely to comply with the study protocol e.g. unable to return periodically for subsequent visits.
  8. Patients who are judged by the investigator as inappropriate to participate in the study for any reason other than those mentioned.
Both
18 Years to 55 Years
No
Contact information is only displayed when the study is recruiting subjects
Not Provided
 
NCT01398670
P3-LIS-IMSFDA-01
No
Wockhardt
Wockhardt
Not Provided
Study Director: Dr.Rasendrakumar Jha Wockhardt
Wockhardt
January 2013

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