GSK189075, GW869682 Or Placebo In Type 2 Diabetic Patients

Diabetes Mellitus, Type 2 Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00291356
• Other study ID #: KG2104940
• Status: Completed
• Phase: Phase 2
• First received: February 13, 2006
• Last updated: April 14, 2015
• Start date: January 2006
• Est. completion date: May 2006

Study information

• Verified date: April 2015
• Source: GlaxoSmithKline
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 45
• Est. completion date: May 2006
• Est. primary completion date: May 2006
• Accepts healthy volunteers: No
• Gender: All
• Age group: 30 Years to 70 Years

Eligibility

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.

Related Conditions & MeSH terms

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

Intervention

Drug:
• GSK189075 oral tablets

• GW869682 oral tablets

Locations

Country	Name	City	State
Germany	GSK Investigational Site	Berlin
Germany	GSK Investigational Site	Neuss	Nordrhein-Westfalen
United States	GSK Investigational Site	Chula Vista	California

Sponsors (1)

Lead Sponsor	Collaborator
GlaxoSmithKline

Countries where clinical trial is conducted

United States,  Germany, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	Amount and percentage of glucose excreted in urine by kidneys. Effect of compounds on lipid metabolism analysed.