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NCT00519480 · ClinicalTrials.gov registry record · Phase 1

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

A Phase 1 study of Diabetes Mellitus, Type 2, sponsored by GlaxoSmithKline.

Completed
Registry status
Phase 1
Development phase
50
Enrollment target
4
Study locations

NCT00519480 is a Phase 1 study of Diabetes Mellitus, Type 2 that has completed, run by GlaxoSmithKline. The registered enrollment target is 50 participants, below the 4,485-participant average among 348 other Diabetes Mellitus, Type 2 trials with a reported enrollment target (99% lower). The trial reports 4 study locations across 3 states.

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The verdict

NCT00519480, a Phase 1 study of Diabetes Mellitus, Type 2, has completed, sponsored by GlaxoSmithKline.

COMPLETED
Registry status
Phase 1
Development phase
50 participants
Enrollment target
4
Study locations

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 Studied

Diabetes Mellitus, Type 2

Interventions

  • DRUG Placebo
  • DRUG Metformin
  • DRUG GSK189075

Study Locations (4)

Other

  • GSK Investigational Site - Buenos Aires
  • GSK Investigational Site - Berlin

Florida

  • GSK Investigational Site - Miami

Texas

  • GSK Investigational Site - San Antonio

Trial Details

FieldValue
Enrollment Target 50 participants
Start Date 2007-09-11
Est. Completion 2008-04-01
Phase Phase 1

Sponsor

GlaxoSmithKline

1,345 total trials

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What the Registry Record Tells You About NCT00519480

The ClinicalTrials.gov registry entry for NCT00519480 describes a study currently listed as completed, categorized as Phase 1. The registered enrollment target is 50 participants, a figure that helps gauge the scale of data the investigators plan to collect, below the 4,485-participant average among 348 other Diabetes Mellitus, Type 2 trials with a reported enrollment target (99% lower). The listed sponsor is GlaxoSmithKline, which has 1,345 total studies on file at ClinicalTrials.gov.

The record links to 1 condition, with Diabetes Mellitus, Type 2 appearing as the primary indexed condition, and to 3 interventions - of which Placebo is the first listed.

NCT00519480 reports 4 study locations spanning 3 distinct geographic areas - top geographies include Other, Florida, Texas.

Frequently Asked Questions

What is clinical trial NCT00519480 about?

NCT00519480 is a clinical study titled "A Study To Assess The Safety And Tolerability Of GSK189075 When Given With A Total Daily Dose Of >/ 2000mg of Metformin". 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...

What is the current status of trial NCT00519480?

This trial is currently completed. It is a Phase 1 study. The enrollment target is 50 participants. The study started on 2007-09-11. Estimated completion is 2008-04-01.

What conditions does trial NCT00519480 study?

This clinical trial studies the following conditions: Diabetes Mellitus, Type 2.

What interventions are being tested in trial NCT00519480?

The interventions under investigation include: Placebo (DRUG), Metformin (DRUG), GSK189075 (DRUG).

Who is sponsoring clinical trial NCT00519480?

This trial is sponsored by GlaxoSmithKline, which has 1,345 total clinical trials registered on ClinicalTrials.gov.

Where is trial NCT00519480 being conducted?

This trial has 4 study locations across Florida, Texas. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.

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Every figure on PlainTrial is rendered directly from the ClinicalTrials.gov registry, no number is typed in by an editor. This page mirrors this trial's own ClinicalTrials.gov registry record, live from the dataset. See our editorial standards & corrections policy, the methodology behind these numbers, or report a data error.