Clinical trial NCT00291356: GSK189075, GW869682 Or Placebo In Type 2 Diabetic Patients
Official title: 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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Diabetes Mellitus, Type 2
Non-Insulin-Dependent Diabetes Mellitus
Keywords: Diabetes
sodium dependent glucose transporter
SGLT2
GSK189075
GSK189074
SGLT1
GW869683
Lead sponsor: GlaxoSmithKline
Sponsor class: INDUSTRY
First posted: 2006-02-14
Enrollment: 45
Sex: ALL
Minimum age (years): 30
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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.


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.

Primary outcomes:
measure: 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:
measure: Amount and percentage of glucose excreted in urine by kidneys. Effect of compounds on lipid metabolism analysed.
Other outcomes:
Locations:
city: Chula Vista
country: United States
facility: GSK Investigational Site
state: California
city: Neuss
country: Germany
facility: GSK Investigational Site
state: Nordrhein-Westfalen
city: Berlin
country: Germany
facility: GSK Investigational Site
Study officials:
affiliation: GlaxoSmithKline
name: GSK Clinical Trials
role: STUDY_DIRECTOR
References: