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A Study To Assess The Safety And Tolerability Of GSK189075 When Given With A Total Daily Dose Of >/ 2000mg of Metformin

NCT00519480 · Status: COMPLETED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 50

Last updated 2017-09-06

No results posted yet for this study

Summary

This study will assess safety and tolerability of metformin plus GSK189075 in people with Type 2 Diabetes. About 48 people will participate in this study. Volunteers will not know if they are receiving GSK189075 or a placebo. Participation will last about 5 weeks including a run-in period of up to 2 weeks if necessary to increase metformin up to 2000mg daily, a 13-day treatment period, and a follow-up visit about 1 week after the treatment period. Volunteers will remain in the research clinic beginning 2 days before they receive the first dose of GSK189075 until after the morning dose on the fourth day and from the afternoon of the 12th day of dosing until the morning after the last dose. They will have clinic visits on dosing Days 6, 8, and 10. Volunteers will be given equipment and instructions for measuring their blood sugar at home and will be asked to keep a study diary. Blood pressure, heart rate, laboratory tests on blood and urine, physical examinations, reports of drug side effects and ECGs will be obtained during the clinic visits to assess safety.

Conditions

  • Diabetes Mellitus, Type 2

Interventions

DRUG

GSK189075

GSK189075 will be available as an oral tablet with dosing strengths of 500 milligrams and 250 milligrams.

DRUG

Metformin

Metformin will be available as an immediate release oral tablet with dosing strengths of 500 milligrams and 850 milligrams.

DRUG

Placebo

Placebo will be available as an oral tablets.

Sponsors & Collaborators

Principal Investigators

  • GSK Clinical Trials · GlaxoSmithKline

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Model
PARALLEL

Eligibility

Min Age
30 Years
Max Age
64 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2007-09-11
Primary Completion
2008-04-01
Completion
2008-04-01

Countries

  • United States
  • Argentina
  • Germany

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 NCT00519480 on ClinicalTrials.gov