GSK189075, GW869682 Or Placebo In Type 2 Diabetic Patients

NCT ID: NCT00291356

Last Updated: 2015-04-15

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE2
• Total Enrollment: 45 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2006-01-31
• Study Completion Date: 2006-05-31

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.

Conditions

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

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: DOUBLE

Interventions

GSK189075 oral tablets

Intervention Type: DRUG

GW869682 oral tablets

Intervention Type: DRUG

Other Intervention Names

GSK189075 oral tablets

Eligibility 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.

• Minimum Eligible Age: 30 Years
• Maximum Eligible Age: 70 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

GlaxoSmithKline

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

GSK Clinical Trials

Role: STUDY_DIRECTOR

GlaxoSmithKline

Locations

GSK Investigational Site

Chula Vista, California, United States

GSK Investigational Site

Neuss, North Rhine-Westphalia, Germany

GSK Investigational Site

Berlin, State of Berlin, Germany

Countries

United States; Germany

Other Identifiers

KG2104940

Identifier Type: -

Identifier Source: org_study_id