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GSK189075, GW869682 Or Placebo In Type 2 Diabetic Patients

Primary Purpose

Diabetes Mellitus, Type 2, Non-Insulin-Dependent Diabetes Mellitus

Status
Completed
Phase
Phase 2
Locations
International
Study Type
Interventional
Intervention
GSK189075 oral tablets
GW869682 oral tablets
Sponsored by
GlaxoSmithKline
About
Eligibility
Locations
Outcomes
Full info

About this trial

This is an interventional treatment trial for Diabetes Mellitus, Type 2 focused on measuring Diabetes, sodium dependent glucose transporter, SGLT2, GSK189075, GSK189074, SGLT1, GW869683

Eligibility Criteria

30 Years - 70 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

  • GSK Investigational Site
  • GSK Investigational Site
  • GSK Investigational Site

Outcomes

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.

Full Information

First Posted
February 13, 2006
Last Updated
April 14, 2015
Sponsor
GlaxoSmithKline
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1. Study Identification

Unique Protocol Identification Number
NCT00291356
Brief Title
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

2. Study Status

Record Verification Date
April 2015
Overall Recruitment Status
Completed
Study Start Date
January 2006 (undefined)
Primary Completion Date
May 2006 (Actual)
Study Completion Date
May 2006 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
GlaxoSmithKline

4. Oversight

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Diabetes Mellitus, Type 2, Non-Insulin-Dependent Diabetes Mellitus
Keywords
Diabetes, sodium dependent glucose transporter, SGLT2, GSK189075, GSK189074, SGLT1, GW869683

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Single Group Assignment
Masking
Double
Allocation
Randomized
Enrollment
45 (Actual)

8. Arms, Groups, and Interventions

Intervention Type
Drug
Intervention Name(s)
GSK189075 oral tablets
Intervention Type
Drug
Intervention Name(s)
GW869682 oral tablets
Other Intervention Name(s)
GSK189075 oral tablets
Primary Outcome Measure Information:
Title
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 Measure Information:
Title
Amount and percentage of glucose excreted in urine by kidneys. Effect of compounds on lipid metabolism analysed.

10. Eligibility

Sex
All
Minimum Age & Unit of Time
30 Years
Maximum Age & Unit of Time
70 Years
Accepts Healthy Volunteers
No
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
GSK Clinical Trials
Organizational Affiliation
GlaxoSmithKline
Official's Role
Study Director
Facility Information:
Facility Name
GSK Investigational Site
City
Chula Vista
State/Province
California
ZIP/Postal Code
91910
Country
United States
Facility Name
GSK Investigational Site
City
Neuss
State/Province
Nordrhein-Westfalen
ZIP/Postal Code
41460
Country
Germany
Facility Name
GSK Investigational Site
City
Berlin
ZIP/Postal Code
14050
Country
Germany

12. IPD Sharing Statement

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GSK189075, GW869682 Or Placebo In Type 2 Diabetic Patients

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