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

Information source: Wockhardt
ClinicalTrials.gov processed this data on August 23, 2015
Link to the current ClinicalTrials.gov record.

Condition(s) targeted: Type I Diabetes

Intervention: Insulin Lispro (Biological); Insulin Lispro (Biological)

Phase: Phase 3

Status: Withdrawn

Sponsored by: Wockhardt

Official(s) and/or principal investigator(s):
Dr.Rasendrakumar Jha, Study Director, Affiliation: Wockhardt


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

Clinical Details

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 design: Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Primary outcome: Change in HbA1c

Secondary outcome:

Percentage change in the immunogenic response

Correlation of the immunogenicity with hypoglycemia

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.


Minimum age: 18 Years. Maximum age: 55 Years. Gender(s): Both.


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.

Locations and Contacts

Additional Information

Starting date: February 2012
Last updated: January 24, 2013

Page last updated: August 23, 2015

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