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

This Tabular View shows the required WHO registration data elements as marked by ^†

Tracking Information

First Received Date ^†

February 24, 2006

Last Updated Date

October 15, 2008

Start Date ^†

January 2006

Current Primary Outcome Measures ^†

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

Original Primary Outcome Measures ^†

Same as current

Change History

Complete list of historical versions of study NCT00297180 on ClinicalTrials.gov Archive Site

Current Secondary Outcome Measures ^†

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

Original Secondary Outcome Measures ^†

Same as current

Descriptive Information

Brief Title ^†

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

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

Brief Summary

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.

Detailed Description

Study Phase

Phase II

Study Type ^†

Interventional

Study Design ^†

Treatment, Randomized, Double-Blind, Single Group Assignment, Efficacy Study

Condition ^†

Obesity

Intervention ^†

Drug: GW869682

Study Arms / Comparison Groups

Publications *

* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.

Recruitment Information

Recruitment Status ^†

Completed

Enrollment ^†

140

Completion Date

Primary Completion Date

Eligibility 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.

Gender

Both

Ages

18 Years to 64 Years

Accepts Healthy Volunteers

Yes

Contacts ^††

Location Countries ^†

United States

Expanded Access Status

Administrative Information

NCT ID ^†

NCT00297180

Responsible Party

Study Director, GSK

Secondary IDs ^††

Study Sponsor ^†

GlaxoSmithKline

Collaborators ^††

Investigators ^†

Study Director:

GSK Clinical Trials, MD

GlaxoSmithKline

Information Provided By

GlaxoSmithKline

Verification Date

October 2008

^† Required WHO trial registration data element.
^†† WHO trial registration data element that is required only if it exists.