GSK189075, GW869682 Or Placebo In Type 2 Diabetic Patients

April 14, 2015 updated by: GlaxoSmithKline

A Double-blind, Randomized, Placebo-controlled, Repeat Dose Study to Compare the Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of GSK189075 With GW869682 in Subjects With Type 2 Diabetes Mellitus

This is a study to compare the safety, blood concentrations, and effects of GSK189075, GW869682, and placebo when dosed for 2-weeks by mouth to patients with type 2 diabetes.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

45

Phase

  • Phase 2

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Germany
      • Berlin, Germany, 14050
        • GSK Investigational Site
    • Nordrhein-Westfalen
      • Neuss, Nordrhein-Westfalen, Germany, 41460
        • GSK Investigational Site
  • United States
    • California
      • Chula Vista, California, United States, 91910
        • GSK Investigational Site

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

30 years to 70 years (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion criteria:

  • Type 2 diabetes.
  • HbA1c (a measure of the average amount of sugar in blood over the last 2 or 3 months) levels are between 7.0 and 9.0.
  • Taking 850mg or more per day metformin, but not taking any other diabetes medications.
  • Must be medically able and willing to discontinue diabetic medications from at least 2 weeks prior to first study dose until the last study assessment.
  • Diabetic subjects who have not yet started taking diabetes medications or whose diabetes is controlled by diet alone may also be eligible to enroll if their HbA1c is within 7.5 to 9.0.
  • Women may be eligible if they are post-menopausal or surgically sterile.
  • If taking ACE inhibitors, beta-blockers, calcium channel blockers, or statin type drugs, you may be eligible if your dose has been stable for at least 30 days prior to the start of the clinical trial.

Exclusion criteria:

  • Using illicit drugs, or have antibodies to hepatitis B, hepatitis C, or HIV.
  • Have any major health problems other than type 2 diabetes.
  • Require insulin therapy or oral antidiabetic medication other than metformin.
  • Subjects who have had a urinary tract infection within 4 weeks of the start of the study or who have kidney disease.
  • Subjects with either low or high blood pressure.
  • Men who are unwilling to abstain from intercourse, or use a condom with a pregnant or nursing female, or who are unwilling to use a condom with another form of contraception with a female who could become pregnant.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: TREATMENT
  • Allocation: RANDOMIZED
  • Interventional Model: SINGLE_GROUP
  • Masking: DOUBLE

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Safety and tolerability: side effects and relevant changes in blood pressure, heart rate and ECG measurements, blood and urine measurements, the amount of fluid taken in and excreted, and kidney function will be monitored over course of study.

Secondary Outcome Measures

Outcome Measure
Amount and percentage of glucose excreted in urine by kidneys. Effect of compounds on lipid metabolism analysed.

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

GlaxoSmithKline

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

January 1, 2006

Primary Completion (ACTUAL)

May 1, 2006

Study Completion (ACTUAL)

May 1, 2006

Study Registration Dates

First Submitted

February 13, 2006

First Submitted That Met QC Criteria

February 13, 2006

First Posted (ESTIMATE)

February 14, 2006

Study Record Updates

Last Update Posted (ESTIMATE)

April 15, 2015

Last Update Submitted That Met QC Criteria

April 14, 2015

Last Verified

April 1, 2015

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • KG2104940

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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