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Comparative Glucose Clamp Study of Wockhardt's Recombinant Insulin Analog Glargine(Glaritus) With Lantus in T1DM

NCT01357603 · Status: COMPLETED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 111

Last updated 2013-01-25

No results posted yet for this study

Summary

The aim of this trial is to demonstrate bioequivalence of Glaritus® to Lantus® with regard to its total and to its maximum serum insulin concentrations.

Conditions

  • Type1 Diabetes

Interventions

BIOLOGICAL

Glargine

dosage form: Subcutaneous injection

Sponsors & Collaborators

  • Wockhardt

    lead INDUSTRY

Principal Investigators

  • Dr. Elaine Watkins · Profil Institute of Clinical Research

Study Design

Allocation
RANDOMIZED
Purpose
HEALTH_SERVICES_RESEARCH
Masking
QUADRUPLE
Model
CROSSOVER

Eligibility

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

Timeline & Regulatory

Start
2011-06-30
Primary Completion
2012-05-31
Completion
2012-08-31

Countries

  • United States

Study Locations

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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 NCT01357603 on ClinicalTrials.gov