NCT00291356

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.

Trial Health

90
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
45

participants targeted

Target at P25-P50 for phase_2 diabetes-mellitus-type-2

Timeline
Completed

Started Jan 2006

Shorter than P25 for phase_2 diabetes-mellitus-type-2

Geographic Reach
2 countries

3 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 1, 2006

Completed
1 month until next milestone

First Submitted

Initial submission to the registry

February 13, 2006

Completed
1 day until next milestone

First Posted

Study publicly available on registry

February 14, 2006

Completed
3 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 1, 2006

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

May 1, 2006

Completed
Last Updated

April 15, 2015

Status Verified

April 1, 2015

Enrollment Period

4 months

First QC Date

February 13, 2006

Last Update Submit

April 14, 2015

Conditions

Diabetes Mellitus, Type 2Non-Insulin-Dependent Diabetes Mellitus

Keywords

Diabetessodium dependent glucose transporterSGLT2GSK189075GSK189074SGLT1GW869683

Outcome Measures

Primary Outcomes (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 Outcomes (1)

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

Interventions

GSK189075 oral tabletsDRUG
GW869682 oral tabletsDRUG
Also known as: GSK189075 oral tablets

Eligibility Criteria

Age30 Years - 70 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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.

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (3)

GSK Investigational Site

Chula Vista, California, 91910, United States

Location

GSK Investigational Site

Neuss, North Rhine-Westphalia, 41460, Germany

Location

GSK Investigational Site

Berlin, State of Berlin, 14050, Germany

Location

MeSH Terms

Conditions

Diabetes Mellitus, Type 2Diabetes Mellitus

Condition Hierarchy (Ancestors)

Glucose Metabolism DisordersMetabolic DiseasesNutritional and Metabolic DiseasesEndocrine System Diseases

Study Officials

  • GSK Clinical Trials

    GlaxoSmithKline

    STUDY DIRECTOR

Study Design

Study Type
interventional
Phase
phase 2
Allocation
RANDOMIZED
Masking
DOUBLE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

February 13, 2006

First Posted

February 14, 2006

Study Start

January 1, 2006

Primary Completion

May 1, 2006

Study Completion

May 1, 2006

Last Updated

April 15, 2015

Record last verified: 2015-04

Locations

US(1)DE(2)