GSK189075, GW869682 Or Placebo In Type 2 Diabetic Patients

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00291356
Recruitment Status : Completed
First Posted : February 14, 2006
Last Update Posted : April 15, 2015
Information provided by (Responsible Party):

Brief Summary:
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.

Condition or disease Intervention/treatment Phase
Diabetes Mellitus, Type 2 Non-Insulin-Dependent Diabetes Mellitus Drug: GSK189075 oral tablets Drug: GW869682 oral tablets Phase 2

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 45 participants
Allocation: Randomized
Intervention Model: Single Group Assignment
Masking: Double
Primary Purpose: Treatment
Official Title: 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
Study Start Date : January 2006
Actual Primary Completion Date : May 2006
Actual Study Completion Date : May 2006

Resource links provided by the National Library of Medicine

U.S. FDA Resources

Intervention Details:
    Drug: GSK189075 oral tablets Drug: GW869682 oral tablets
    Other Name: GSK189075 oral tablets

Primary Outcome Measures :
  1. 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 :
  1. Amount and percentage of glucose excreted in urine by kidneys. Effect of compounds on lipid metabolism analysed.

Information from the National Library of Medicine

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Ages Eligible for Study:   30 Years to 70 Years   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT00291356

United States, California
GSK Investigational Site
Chula Vista, California, United States, 91910
GSK Investigational Site
Neuss, Nordrhein-Westfalen, Germany, 41460
GSK Investigational Site
Berlin, Germany, 14050
Sponsors and Collaborators
Study Director: GSK Clinical Trials GlaxoSmithKline

Responsible Party: GlaxoSmithKline Identifier: NCT00291356     History of Changes
Other Study ID Numbers: KG2104940
First Posted: February 14, 2006    Key Record Dates
Last Update Posted: April 15, 2015
Last Verified: April 2015

Keywords provided by GlaxoSmithKline:
sodium dependent glucose transporter

Additional relevant MeSH terms:
Diabetes Mellitus
Diabetes Mellitus, Type 2
Glucose Metabolism Disorders
Metabolic Diseases
Endocrine System Diseases