Immunogenicity Safety Study of Wockhardt's Recombinant Insulin Analogue in Type 1 Diabetic Patients

NCT01352663 | Withdrawn Phase 3

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

Brief Summary

This is an open label, randomized, parallel group comparison of the immunogenicity safety of Wockhardt's Recombinant Insulin Analogue with the innovator's Glargine in Type 1 diabetics patients.

Conditions

Type I Diabetes

Keywords

Type I Diabetes; Wockhardt; Insulin Analogue

Outcome Measures

Primary Outcomes (1)

• Change in HbAlc from baseline till the end of treatment period.

  12 months

Secondary Outcomes (1)

• Percentage change in immunogenic response.

  12 months

Study Arms (2)

Wockhardt's Insulin Analogue (Recomb)

EXPERIMENTAL

Basal bolus Wockhardt's Recombinant Insulin Analogue to be injected subcutaneously.

Biological: Wockhardt's Insulin Analogue (Recomb)

Lantus®

ACTIVE COMPARATOR

Basal bolus Insulin analog glargine (Lantus®) to be injected subcutaneously.

Biological: Lantus®

Interventions

Wockhardt's Insulin Analogue (Recomb) BIOLOGICAL

Basal bolus Wockhardt's Recombinant Insulin Analogue to be injected subcutaneously.

Wockhardt's Insulin Analogue (Recomb)

Lantus® BIOLOGICAL

Basal bolus Insulin analog glargine (Lantus®) to be injected subcutaneously.

Lantus®

Eligibility Criteria

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

You may qualify if:

• 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 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.

You may not qualify if:

• A Patient who is pregnant or is currently breast-feeding.
• A Patient with history of severe hypoglycemia within the past year
• 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.
• Patients who are Hepatitis B or C positive on testing or have positive medical history of HIV at screening.
• Patients unlikely to comply with the study protocol e.g. unable to return periodically for subsequent visits.

Sponsors & Collaborators

• Wockhardt: lead

MeSH Terms

Conditions

Diabetes Mellitus, Type 1

Interventions

Insulin Glargine

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

Study Officials

• Dr Ashima Bhatia, M.D.

  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: May 9, 2011
• First Posted: May 12, 2011
• Last Updated: October 8, 2019

Record last verified: 2019-10