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Investigate the Efficacy and Safety of GSK1070806 in Obese Subjects With T2DM

NCT01648153 · Status: COMPLETED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 37

Last updated 2016-11-21

No results posted yet for this study

Summary

GSK1070806 is a humanised IgG1/kappa antibody which is directed against the soluble cytokine interleukin-18 (IL-18). The aims of this placebo controlled study are to evaluate the efficacy, safety, tolerability, pharmacokinetics and pharmacodynamics of GSK1070806 in obese subjects with Type 2 diabetes mellitus (T2DM), and to gain a better understanding of the mechanism by which GSK1070806 exerts its therapeutic effects.

Conditions

Interventions

BIOLOGICAL

GSK1070806

To investigate the efficacy and biomarker changes of GSK1070806 after 0.25mg/kg IV administration

OTHER

Placebo (saline)

To compare the efficacy and biomarker changes between placebo and active groups

BIOLOGICAL

GSK1070806

To investigate the efficacy and biomarker changes of GSK1070806 after 5mg/kg IV administration

Sponsors & Collaborators

Principal Investigators

  • GSK Clinical Trials · GlaxoSmithKline

Study Design

Allocation
RANDOMIZED
Purpose
BASIC_SCIENCE
Masking
SINGLE
Model
PARALLEL

Eligibility

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

Timeline & Regulatory

Start
2012-08-31
Primary Completion
2013-09-30
Completion
2014-01-31

Countries

  • Spain
  • United Kingdom

Study Locations

More Related Trials

Entities

Diseases
Companies

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 NCT01648153 on ClinicalTrials.gov