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A Phase 1 Study to Evaluate the Effect of GSK256073, an HM74A Receptor Agonist, on Glucose and NEFA Levels in Type 2 Diabetics

NCT01147861 · Status: COMPLETED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 39

Last updated 2017-06-14

No results posted yet for this study

Summary

The aim of this study is to verify whether a significant decrease in glucose levels can be achieved with the HM74A agonist GSK256073 in type 2 diabetic patients. Several dose levels and a placebo will be evaluated in a three period crossover study with two active doses and one placebo dose per subject, in order to determine whether there is a dose that produces glucose lowering in the target population. In addition, this study will investigate the optimal dosing regimen for full manifestation of any metabolic effect of GSK256073 by comparing once a day versus twice a day regimens.

Conditions

  • Diabetes Mellitus, Type 2

Interventions

DRUG

GSK256073

5mg in the AM and 5mg in the PM

DRUG

GSK256073

10mg in the AM

DRUG

GSK256073

50mg in the AM

DRUG

GSK256073

25mg in the AM and 25mg in the PM

OTHER

Placebo

2 placebo tablets in the AM and 2 placebo tablets in the PM

Sponsors & Collaborators

Principal Investigators

  • GSK Clinical Trials · GlaxoSmithKline

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
SINGLE
Model
CROSSOVER

Eligibility

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

Timeline & Regulatory

Start
2010-07-01
Primary Completion
2010-09-07
Completion
2010-09-07

Countries

  • United States

Study Locations

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Entities

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 NCT01147861 on ClinicalTrials.gov