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

January 24, 2013 updated by: Wockhardt

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

Study Overview

Status

Withdrawn

Conditions

Intervention / Treatment

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.

Study Type

Interventional

Phase

  • Phase 3

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

16 years to 53 years (Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Lispro arm
Lispro and Lispro Mix 75/25 /Lispro Mix 50/50
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
Active Comparator: Humalog® arm
Humalog® and Humalog® Mix75/25 / Humalog® Mix50/50
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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Change in HbA1c
Time Frame: 6 months
6 months

Secondary Outcome Measures

Outcome Measure
Time Frame
Percentage change in the immunogenic response
Time Frame: 6 months
6 months
Correlation of the immunogenicity with hypoglycemia
Time Frame: 12 months
12 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Wockhardt

Investigators

  • Study Director: Dr.Rasendrakumar Jha, Wockhardt

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

February 1, 2012

Primary Completion (Anticipated)

March 1, 2013

Study Completion (Anticipated)

May 1, 2013

Study Registration Dates

First Submitted

July 19, 2011

First Submitted That Met QC Criteria

July 19, 2011

First Posted (Estimate)

July 20, 2011

Study Record Updates

Last Update Posted (Estimate)

January 25, 2013

Last Update Submitted That Met QC Criteria

January 24, 2013

Last Verified

January 1, 2013

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • P3-LIS-IMSFDA-01

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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