NCT Number: NCT00291356
GSK189075, GW869682 Or Placebo In Type 2 Diabetic Patients
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.
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Notify MeKey information
Conditions
Age range
30 year–70 year
Sex eligibility
All sexes
Study type
Interventional
Phase
Phase 2
Primary location
GSK Investigational Site, Neuss, North Rhine-Westphalia, Germany
Who can participate
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
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.
Treatment and study plan
GW869682 oral tablets
DrugOther names: GSK189075 oral tablets
Primary outcomes
-
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
-
Amount and percentage of glucose excreted in urine by kidneys. Effect of compounds on lipid metabolism analysed.
Sponsors and collaborators
Lead sponsor
GlaxoSmithKline
Industry
Registry information
Official study 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
Important dates
- Study start
- 2006
- Primary completion
- 2006
- Study completion
- 2006
- First posted
- Feb 14, 2006
- Registry last updated
- Apr 15, 2015
OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.
View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
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