Weight Loss In Obese Subjects Taking Either GW869682 Or Placebo 3 Times Per Day For 12 Weeks

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
GlaxoSmithKline
ClinicalTrials.gov Identifier:
NCT00297180
First received: February 24, 2006
Last updated: May 31, 2012
Last verified: March 2011
  Purpose

GW869682 causes glucose to be excreted in the urine. The purpose of this study is to see whether enough calories from glucose are excreted in the urine to cause weight loss.


Condition Intervention Phase
Obesity
Drug: GW869682
Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Single Group Assignment
Masking: Double-Blind
Primary Purpose: Treatment
Official Title: A Double-Blind, Randomized, Placebo-controlled Study to Evaluate Weight Loss, Safety, Tolerability and Pharmacokinetics in Obese Subjects Following 12-Week Dosing of GW869682, an SGLT2 Inhibitor

Resource links provided by NLM:


Further study details as provided by GlaxoSmithKline:

Primary Outcome Measures:
  • Percentage change in body weight from baseline to Week 12. [ Time Frame: from baseline to Week 12. ]

Secondary Outcome Measures:
  • Blood levels of GW869682 at the Week 2 and Week 11. [ Time Frame: at the Week 2 and Week 11 ]

Enrollment: 140
Study Start Date: January 2006
Intervention Details:
    Drug: GW869682
    Other Name: GW869682
  Eligibility

Ages Eligible for Study:   18 Years to 64 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion criteria:

  • Have a BMI within range 30.0 to 40.0kg/m2, inclusive.
  • Females who meet above criteria must be physiologically incapable of becoming pregnant (ie., surgically sterilized, or post-menopausal per protocol definition).

Exclusion criteria:

  • History of eating disorders.
  • Recent history of weight loss or gain.
  • Had gastrointestinal surgery for treatment of obesity.
  • Type 1 or type 2 diabetes mellitus.
  • Have a positive urine drug screen.
  • Have liver disease.
  • Have hepatitis B, hepatitis C, or HIV antibodies.
  • Have a thyroid disorder that is not under control with medication.
  • Have any disease (such as heart, liver, blood, nervous system, or kidney disease, or cancer).
  • Are unable to participate in an exercise program.
  • Have used weight loss drugs within 3 months before the start of the study.
  • Are currently using warfarin, digoxin, oral anti-coagulants (other than aspirin and non-steroidal anti-inflammatory drugs), oral or injectable corticosteroids (inhaled & intranasal corticosteroids are permitted), or antiretroviral medications.
  • Used of any investigational drug or device during the study or within 30 days prior to 1st dosing of study medication.
  • High or low blood pressure.
  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: NCT00297180

Locations
United States, Florida
GSK Investigational Site
Daytona Beach, Florida, United States, 32114
United States, Louisiana
GSK Investigational Site
Baton Rouge, Louisiana, United States, 70808
United States, Oregon
GSK Investigational Site
Portland, Oregon, United States, 97239
Sponsors and Collaborators
GlaxoSmithKline
Investigators
Study Director: GSK Clinical Trials GlaxoSmithKline
  More Information

No publications provided

Responsible Party: GlaxoSmithKline
ClinicalTrials.gov Identifier: NCT00297180     History of Changes
Other Study ID Numbers: KGO105858
Study First Received: February 24, 2006
Last Updated: May 31, 2012
Health Authority: United States: Food and Drug Administration

Keywords provided by GlaxoSmithKline:
hunger
obesity
sodium-dependent glucose transporter
GW869682
body composition
SGLT2 inhibitor
weight loss

Additional relevant MeSH terms:
Obesity
Weight Loss
Overnutrition
Nutrition Disorders
Overweight
Body Weight
Signs and Symptoms
Body Weight Changes

ClinicalTrials.gov processed this record on July 20, 2014