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

NCT01352663 · Status: WITHDRAWN · Phase: PHASE3 · Type: INTERVENTIONAL

Last updated 2019-10-08

No results posted yet for this study

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

Interventions

BIOLOGICAL

Wockhardt's Insulin Analogue (Recomb)

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

BIOLOGICAL

Lantus®

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

Sponsors & Collaborators

  • Wockhardt

    lead INDUSTRY

Principal Investigators

  • Dr Ashima Bhatia, M.D. · Wockhardt

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
55 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT01352663 on ClinicalTrials.gov