GSK189075, GW869682 Or Placebo In Type 2 Diabetic Patients

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
GlaxoSmithKline
ClinicalTrials.gov Identifier:
NCT00291356
First received: February 13, 2006
Last updated: November 21, 2012
Last verified: November 2012
  Purpose

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 Intervention Phase
Diabetes Mellitus, Type 2
Non-Insulin-Dependent Diabetes Mellitus
Drug: GSK189075 oral tablets
Drug: GW869682 oral tablets
Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety Study
Intervention Model: Single Group Assignment
Masking: Double-Blind
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

Resource links provided by NLM:


Further study details as provided by GlaxoSmithKline:

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

Estimated Enrollment: 45
Study Start Date: January 2006
Intervention Details:
    Drug: GSK189075 oral tablets Drug: GW869682 oral tablets
    Other Names:
    • GW869682 oral tablets
    • GSK189075 oral tablets
  Eligibility

Ages Eligible for Study:   30 Years to 70 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00291356

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

No publications provided

Responsible Party: GlaxoSmithKline
ClinicalTrials.gov Identifier: NCT00291356     History of Changes
Other Study ID Numbers: KG2104940
Study First Received: February 13, 2006
Last Updated: November 21, 2012
Health Authority: Germany: Federal Institute for Drugs and Medical Devices
United States: Food and Drug Administration

Keywords provided by GlaxoSmithKline:
Diabetes
sodium dependent glucose transporter
SGLT2
GSK189075
GSK189074
SGLT1
GW869683

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

ClinicalTrials.gov processed this record on October 20, 2014