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

NCT ID: NCT01398670

Last Updated: 2013-01-25

Basic Information

• Recruitment Status: WITHDRAWN
• Clinical Phase: PHASE3
• Study Classification: INTERVENTIONAL
• Study Start Date: 2012-02-29
• Study Completion Date: 2013-05-31

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.

Conditions

Type I Diabetes

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Lispro arm

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

Group Type: EXPERIMENTAL

Insulin Lispro

Intervention Type: BIOLOGICAL

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

The drugs would be administered subcutaneously

Humalog® arm

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

Group Type: ACTIVE_COMPARATOR

Insulin Lispro

Intervention Type: BIOLOGICAL

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

The drugs would be administered subcutaneously

Interventions

Insulin Lispro

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

The drugs would be administered subcutaneously

Intervention Type: BIOLOGICAL

Insulin Lispro

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

The drugs would be administered subcutaneously

Intervention Type: BIOLOGICAL

Eligibility Criteria

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.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 55 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Wockhardt

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Dr.Rasendrakumar Jha

Role: STUDY_DIRECTOR

Wockhardt

Other Identifiers

P3-LIS-IMSFDA-01

Identifier Type: -

Identifier Source: org_study_id