GSK189075, GW869682 Or Placebo In Type 2 Diabetic Patients



Status:Completed
Conditions:Diabetes, Diabetes
Therapuetic Areas:Endocrinology
Healthy:No
Age Range:30 - 70
Updated:10/14/2017
Start Date:January 2006
End Date:May 2006

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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

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.


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.
We found this trial at
2
sites
Neuss, Nordrhein-Westfalen 41460
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Neuss,
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Chula Vista, California 91911
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Chula Vista, CA
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