Diabetes Mellitus, Type 2, Non-Insulin-Dependent Diabetes Mellitus
Conditions
Keywords
Diabetes, sodium dependent glucose transporter, SGLT2, GSK189075, GSK189074, SGLT1, GW869683
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.
Interventions
DRUGGW869682 oral tablets
Sponsors
GlaxoSmithKline
Study design
Allocation
RANDOMIZED
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
DOUBLE
Eligibility
Sex/Gender
ALL
Age
30 Years to 70 Years
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 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
| Measure | Time frame |
|---|---|
| Amount and percentage of glucose excreted in urine by kidneys. Effect of compounds on lipid metabolism analysed. | — |
Countries
Germany, United States
Outcome results
None listed