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

Phase 3

Withdrawn

• Conditions: Type I Diabetes
• Interventions: Biological: Insulin Lispro

• Registration Number: NCT01398670
• Lead Sponsor: Wockhardt

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.

Study Timeline

• Study First Submitted: 2011-07-19
• Study First Submitted QC: 2011-07-19
• Study First Posted: 2011-07-20
• Study Start: 2012-02
• Status Verified: 2013-01
• Last Update Submitted: 2013-01-24
• Last Update Posted: 2013-01-25
• Primary Completion: 2013-03
• Study Completion: 2013-05

Recruitment & Eligibility

• Status: WITHDRAWN
• Sex: All
• Target Recruitment: Not specified

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Lispro arm	Insulin Lispro	Lispro and Lispro Mix 75/25 /Lispro Mix 50/50
Humalog® arm	Insulin Lispro	Humalog® and Humalog® Mix75/25 / Humalog® Mix50/50

Primary Outcome Measures

Name	Time	Method
Change in HbA1c	6 months

Secondary Outcome Measures

Name	Time	Method
Percentage change in the immunogenic response	6 months
Correlation of the immunogenicity with hypoglycemia	12 months