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

Type I Diabetes Clinical Trial

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

Clinical Trial Details — Status: Withdrawn

Administrative data

• NCT number: NCT01398670
• Other study ID #: P3-LIS-IMSFDA-01
• Status: Withdrawn
• Phase: Phase 3
• First received: July 19, 2011
• Last updated: January 24, 2013
• Start date: February 2012
• Est. completion date: May 2013

Study information

• Verified date: January 2013
• Source: Wockhardt
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Food and Drug AdministrationIndia: Drugs Controller General of India
• Study type: Interventional

Clinical Trial 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

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.

Recruitment information / eligibility

• Status: Withdrawn
• Enrollment: 0
• Est. completion date: May 2013
• Est. primary completion date: March 2013
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 55 Years

Eligibility

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

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

Related Conditions & MeSH terms

• Diabetes Mellitus, Type 1
• Type I Diabetes

Intervention

Biological:
• Insulin Lispro
a. Lispro and Lispro Mix® 75/25 / Lispro Mix 50/50 The drugs would be administered subcutaneously
• Insulin Lispro
Humalog® and Humalog® Mix75/25 /Humalog® Mix 50/50 The drugs would be administered subcutaneously

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Wockhardt

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Change in HbA1c		6 months	No
Secondary	Percentage change in the immunogenic response		6 months	Yes
Secondary	Correlation of the immunogenicity with hypoglycemia		12 months	Yes