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Status: Withdrawn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
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
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 responseCorrelation 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.
Eligibility
Minimum age: 18 Years.
Maximum age: 55 Years.
Gender(s): Both.
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.
Locations and Contacts
Additional Information
Starting date: February 2012
Last updated: January 24, 2013
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