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

Primary Purpose

Type I Diabetes

Status

Withdrawn

Phase

Phase 3

Locations

Study Type

Interventional

Intervention

Insulin Lispro

About this trial

This is an interventional treatment trial for Type I Diabetes focused on measuring Type I Diabetes, Wockhardt's Insulin analogue Lispro, Humalog®, Humalog Mix, Wockhardt, Biosimilar, Phase 3

Eligibility Criteria

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

Inclusion Criteria:

Patients who understand the nature of the study and are willing to provide written informed consent.
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 body mass index (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.
Ability to use the self glucose-monitoring device and to self inject insulin.

Exclusion Criteria:

Females who are pregnant or lactating, or not practicing adequate contraception.
A Patient with compromised hepatic or renal function
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.
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.
A Patient with history or evidence of allergy to insulin preparations.
A Patients who is currently receiving or has received, within the last year, any immunomodulator medications.
Patients unlikely to comply with the study protocol e.g. unable to return periodically for subsequent visits.
Patients who are judged by the investigator as inappropriate to participate in the study for any reason other than those mentioned.

Sites / Locations

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

Lispro arm

Humalog® arm

Arm Description

Lispro and Lispro Mix 75/25 /Lispro Mix 50/50

Humalog® and Humalog® Mix75/25 / Humalog® Mix50/50

Outcomes

Primary Outcome Measures

Change in HbA1c

Secondary Outcome Measures

Percentage change in the immunogenic response

Correlation of the immunogenicity with hypoglycemia

Full Information

NCT ID

NCT01398670

First Posted

July 19, 2011

Last Updated

January 24, 2013

Sponsor

Wockhardt

1. Study Identification

Unique Protocol Identification Number

NCT01398670

Brief Title

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

Official Title

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

Study Type

Interventional

2. Study Status

Record Verification Date

January 2013

Overall Recruitment Status

Withdrawn

Why Stopped

Study was not initiated

Study Start Date

February 2012 (undefined)

Primary Completion Date

March 2013 (Anticipated)

Study Completion Date

May 2013 (Anticipated)

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 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

Detailed Description

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.

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's Insulin analogue Lispro, Humalog®, Humalog Mix, Wockhardt, Biosimilar, Phase 3

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

Lispro arm

Arm Type

Experimental

Arm Description

Lispro and Lispro Mix 75/25 /Lispro Mix 50/50

Arm Title

Humalog® arm

Arm Type

Active Comparator

Arm Description

Humalog® and Humalog® Mix75/25 / Humalog® Mix50/50

Intervention Type

Biological

Intervention Name(s)

Insulin Lispro

Intervention Description

a. Lispro and Lispro Mix® 75/25 / Lispro Mix 50/50 The drugs would be administered subcutaneously

Intervention Type

Biological

Intervention Name(s)

Insulin Lispro

Intervention Description

Humalog® and Humalog® Mix75/25 /Humalog® Mix 50/50 The drugs would be administered subcutaneously

Primary Outcome Measure Information:

Title

Change in HbA1c

Time Frame

6 months

Secondary Outcome Measure Information:

Title

Percentage change in the immunogenic response

Time Frame

6 months

Title

Correlation of the immunogenicity with hypoglycemia

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 understand the nature of the study and are willing to provide written informed consent. 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 body mass index (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. Ability to use the self glucose-monitoring device and to self inject insulin. Exclusion Criteria: Females who are pregnant or lactating, or not practicing adequate contraception. A Patient with compromised hepatic or renal function 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. 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. A Patient with history or evidence of allergy to insulin preparations. A Patients who is currently receiving or has received, within the last year, any immunomodulator medications. Patients unlikely to comply with the study protocol e.g. unable to return periodically for subsequent visits. Patients who are judged by the investigator as inappropriate to participate in the study for any reason other than those mentioned.

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Dr.Rasendrakumar Jha

Organizational Affiliation

Wockhardt

Official's Role

Study Director

12. IPD Sharing Statement

Learn more about this trial

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

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