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

NCT01398670 · Status: WITHDRAWN · Phase: PHASE3 · Type: INTERVENTIONAL

Last updated 2013-01-25

No results posted yet for this study

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

Interventions

BIOLOGICAL

Insulin Lispro

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

BIOLOGICAL

Insulin Lispro

Humalog® and Humalog® Mix75/25 /Humalog® Mix 50/50 The drugs would be administered subcutaneously

Sponsors & Collaborators

  • Wockhardt

    lead INDUSTRY

Principal Investigators

  • Dr.Rasendrakumar Jha · 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

Start
2012-02-29
Primary Completion
2013-03-31
Completion
2013-05-31

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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 NCT01398670 on ClinicalTrials.gov