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Dose-Ranging Study In Subjects With Type 2 Diabetes Mellitus Who Are Treatment-Naive

NCT00495469 · Status: COMPLETED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 250

Last updated 2017-10-30

Study results available
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Summary

This is a dose-ranging study to evaluate the efficacy, safety and tolerability of a range of doses of GSK189075 (an SGLT2 inhibitor) compared to placebo, administered over 12 weeks in treatment-naive subjects with type 2 diabetes mellitus

Conditions

  • Diabetes Mellitus, Type 2

Interventions

DRUG

GSK189075

GSK189075 is available as a white, capsule-shaped tablet dosage form containing 50mg, 125mg, 250mg or 500mg of GSK189075 per tablet

DRUG

Placebo

Available as Placebo matching tablet to GSK189075

Sponsors & Collaborators

Principal Investigators

  • GSK Clinical Trials · GlaxoSmithKline

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Model
PARALLEL

Eligibility

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

Timeline & Regulatory

Start
2007-08-17
Primary Completion
2008-06-05
Completion
2008-06-05
FDA Drug
Yes

Countries

  • United States
  • Canada
  • Czechia
  • Estonia
  • Germany
  • Greece
  • India
  • Lithuania
  • Mexico
  • New Zealand
  • Poland
  • Puerto Rico
  • Romania
  • Russia
  • South Africa
  • Ukraine

Study Locations

More Related Trials

Entities

Drugs
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 NCT00495469 on ClinicalTrials.gov