GSK189075, GW869682 Or Placebo In Type 2 Diabetic Patients
This study has been completed.
Sponsor:
GlaxoSmithKline
Information provided by (Responsible Party):
GlaxoSmithKline
ClinicalTrials.gov Identifier:
NCT00291356
First received: February 13, 2006
Last updated: November 21, 2012
Last verified: November 2012
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Purpose
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.
| Condition | Intervention | Phase |
|---|---|---|
|
Diabetes Mellitus, Type 2 Non-Insulin-Dependent Diabetes Mellitus |
Drug: GSK189075 oral tablets Drug: GW869682 oral tablets |
Phase 2 |
| Study Type: | Interventional |
| Study Design: | Allocation: Randomized Endpoint Classification: Safety Study Intervention Model: Single Group Assignment Masking: Double-Blind Primary Purpose: Treatment |
| 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 |
Resource links provided by NLM:
Further study details as provided by GlaxoSmithKline:
Primary Outcome Measures:
- 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 Outcome Measures:
- Amount and percentage of glucose excreted in urine by kidneys. Effect of compounds on lipid metabolism analysed.
| Estimated Enrollment: | 45 |
| Study Start Date: | January 2006 |
Intervention Details:
-
Drug: GSK189075 oral tablets
Drug: GW869682 oral tablets
- GW869682 oral tablets
- GSK189075 oral tablets
Other Names:
Eligibility| Ages Eligible for Study: | 30 Years to 70 Years |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
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.
Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00291356
Locations
| United States, California | |
| GSK Investigational Site | |
| Chula Vista, California, United States, 91910 | |
| Germany | |
| GSK Investigational Site | |
| Neuss, Nordrhein-Westfalen, Germany, 41460 | |
| GSK Investigational Site | |
| Berlin, Germany, 14050 | |
Sponsors and Collaborators
GlaxoSmithKline
Investigators
| Study Director: | GSK Clinical Trials | GlaxoSmithKline |
More Information
No publications provided
| Responsible Party: | GlaxoSmithKline |
| ClinicalTrials.gov Identifier: | NCT00291356 History of Changes |
| Other Study ID Numbers: | KG2104940 |
| Study First Received: | February 13, 2006 |
| Last Updated: | November 21, 2012 |
| Health Authority: | Germany: Federal Institute for Drugs and Medical Devices United States: Food and Drug Administration |
Keywords provided by GlaxoSmithKline:
|
Diabetes sodium dependent glucose transporter SGLT2 GSK189075 |
GSK189074 SGLT1 GW869683 |
Additional relevant MeSH terms:
|
Diabetes Mellitus Diabetes Mellitus, Type 2 Glucose Metabolism Disorders Metabolic Diseases Endocrine System Diseases |
ClinicalTrials.gov processed this record on May 21, 2013