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Withdrawn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
Insulin Lispro
Sponsored by
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
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
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
No
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
No
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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