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

NCT01398670 | Withdrawn Phase 3

• 1 other identifier: P3-LIS-IMSFDA-01
• Study Type: interventional
• Target: N/A
• Locations: 0 countries
• Sites: N/A

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

Conditions

Type I Diabetes

Keywords

Type I Diabetes; Wockhardt's Insulin analogue Lispro; Humalog®; Humalog Mix; Wockhardt; Biosimilar; Phase 3

Outcome Measures

Primary Outcomes (1)

• Change in HbA1c

  6 months

Secondary Outcomes (2)

• Percentage change in the immunogenic response

  6 months

• Correlation of the immunogenicity with hypoglycemia

  12 months

Study Arms (2)

Lispro arm

EXPERIMENTAL

Lispro and Lispro Mix 75/25 /Lispro Mix 50/50

Biological: Insulin Lispro

Humalog® arm

ACTIVE COMPARATOR

Humalog® and Humalog® Mix75/25 / Humalog® Mix50/50

Biological: Insulin Lispro

Interventions

Insulin Lispro BIOLOGICAL

a. Lispro and Lispro Mix® 75/25 / Lispro Mix 50/50 The drugs would be administered subcutaneously

Lispro arm

Eligibility Criteria

• Age: 18 Years - 55 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• Patients who understand the nature of the study and are willing to provide written informed consent.
• Patients who have been pre-diagnosed as cases of type-1 diabetes for a period not less than 1 year
• Male or Female Patients ≥ 18 and \< 55 years of age.
• Patients with body mass index (BMI) of 18.0 to 30.0 kg/m2
• Patients who are cooperative, reliable, and agree to have regular injections of insulin and are willing to comply with protocol procedures.
• Ability to use the self glucose-monitoring device and to self inject insulin.

You may not qualify if:

• Females who are pregnant or lactating, or not practicing adequate contraception.
• A Patient with compromised hepatic or renal function
• 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.
• 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.
• A Patient with history or evidence of allergy to insulin preparations.
• A Patients who is currently receiving or has received, within the last year, any immunomodulator medications.
• Patients unlikely to comply with the study protocol e.g. unable to return periodically for subsequent visits.
• Patients who are judged by the investigator as inappropriate to participate in the study for any reason other than those mentioned.

Sponsors & Collaborators

• Wockhardt: lead

MeSH Terms

Conditions

Diabetes Mellitus, Type 1

Interventions

Insulin Lispro

Condition Hierarchy (Ancestors)

Diabetes Mellitus; Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases; Endocrine System Diseases; Autoimmune Diseases; Immune System Diseases

Intervention Hierarchy (Ancestors)

Insulin, Short-Acting; Insulins; Pancreatic Hormones; Peptide Hormones; Hormones; Hormones, Hormone Substitutes, and Hormone Antagonists; Peptides; Amino Acids, Peptides, and Proteins

Study Officials

• Dr.Rasendrakumar Jha

  Wockhardt

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 19, 2011
• First Posted: July 20, 2011
• Study Start: February 1, 2012
• Primary Completion: March 1, 2013
• Study Completion: May 1, 2013
• Last Updated: January 25, 2013

Record last verified: 2013-01