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

This study has been withdrawn prior to enrollment.
(Study was not initiated)
Sponsor:
Information provided by (Responsible Party):
Wockhardt
ClinicalTrials.gov Identifier:
NCT01398670
First received: July 19, 2011
Last updated: January 24, 2013
Last verified: January 2013
  Purpose

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


Condition Intervention Phase
Type I Diabetes
Biological: Insulin Lispro
Phase 3

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

Resource links provided by NLM:


Further study details as provided by Wockhardt:

Primary Outcome Measures:
  • Change in HbA1c [ Time Frame: 6 months ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Percentage change in the immunogenic response [ Time Frame: 6 months ] [ Designated as safety issue: Yes ]
  • Correlation of the immunogenicity with hypoglycemia [ Time Frame: 12 months ] [ Designated as safety issue: Yes ]

Enrollment: 0
Study Start Date: February 2012
Estimated Study Completion Date: May 2013
Estimated Primary Completion Date: March 2013 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Lispro arm
Lispro and Lispro Mix 75/25 /Lispro Mix 50/50
Biological: Insulin Lispro

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

The drugs would be administered subcutaneously

Active Comparator: Humalog® arm
Humalog® and Humalog® Mix75/25 / Humalog® Mix50/50
Biological: Insulin Lispro

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

The drugs would be administered subcutaneously


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

Ages Eligible for Study:   18 Years to 55 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01398670

Sponsors and Collaborators
Wockhardt
Investigators
Study Director: Dr.Rasendrakumar Jha Wockhardt
  More Information

No publications provided

Responsible Party: Wockhardt
ClinicalTrials.gov Identifier: NCT01398670     History of Changes
Other Study ID Numbers: P3-LIS-IMSFDA-01
Study First Received: July 19, 2011
Last Updated: January 24, 2013
Health Authority: United States: Food and Drug Administration
India: Drugs Controller General of India

Keywords provided by Wockhardt:
Type I Diabetes
Wockhardt's Insulin analogue Lispro
Humalog®
Humalog Mix
Wockhardt
Biosimilar
Phase 3

Additional relevant MeSH terms:
Diabetes Mellitus, Type 1
Autoimmune Diseases
Diabetes Mellitus
Endocrine System Diseases
Glucose Metabolism Disorders
Immune System Diseases
Metabolic Diseases
Insulin
Insulin Lispro
Insulin, Globin Zinc
Hypoglycemic Agents
Pharmacologic Actions
Physiological Effects of Drugs

ClinicalTrials.gov processed this record on October 22, 2014