Study In People With Type 2 Diabetes

Primary Outcomes: Improvement in glucose control over a 16 week period.
Secondary Outcomes: Cholesterol, additional glycemic endpoints, safety endpoints.

Official Title

A Multicenter, Randomized, Double-Blind, Double-Dummy, Parallel-Group, Placebo-Controlled, Study To Evaluate Efficacy, Safety And Tolerability Of Oral GW677954 Capsules (2.5, 5, 10, 15 And 20 Mg Once A Day) As A Monotherapy (Diet and/or Exercise Treated) Or As An Add-On To Metformin For 16 Weeks Duration In Subjects With Type 2 Diabetes Mellitus.

Conditions

Study Type

Interventional

Study Design

Treatment, Randomized, Double-Blind, Placebo Control, Parallel Assignment, Safety/Efficacy Study

Further Details

Study Start

September 2005

Eligibility & Criteria

Ages Eligible for Study: 18 Years – 70 YearsGenders Eligible for Study: Both CriteriaInclusion criteria:- Type 2 diabetes. – Diet and/or exercise treated or receiving stable metformin monotherapy. – Must have an HbA1c level between 8.0% and 10.0%, with FPG < 270 mg/dL (15.0 mmol/L) at screening. - Generally in good health. Exclusion criteria:- Use of lipid lowering agents (including statins, fibrates and ezetimibe), niacin, fat absorption blocking agents, and bile acid sequestrants. - Familial hypercholesterolemia, a history of triglycerides (TGs) in excess of 800 mg/dL (8.96 mmol/L), a history of pancreatitis or a documented recent history of clinically significant cardiovascular disease.

Total Enrolment

448

Contact Details

AustraliaGSK Clinical Trials Call Center, South Australia, 5035, Australia; Not yet recruiting GSK Clinical Trials Call Center 1-877-379-3718 saecr@senet.com.au GSK Clinical Trials Call Center, South Australia, 50000, Australia; Not yet recruiting GSK Clinical Trials Call Center 1-877-379-3718 susan.oconnor@adelaide.edu.au GSK Clinical Trials Call Center, Victoria, 3135, Australia; Not yet recruiting GSK Clinical Trials Call Center 1-877-379-3718 Patricia.Woolven@maroondah.org.au GSK Clinical Trials Call Center, Victoria, 31280, Australia; Not yet recruiting GSK Clinical Trials Call Center 1-877-379-3718 vanessa.viola@med.monash.edu.au GSK Clinical Trials Call Center, Queensland, 41520, Australia; Not yet recruiting GSK Clinical Trials Call Center 1-877-379-3718 bscrc@bigpond.net.au GSK Clinical Trials Call Center, South Australia, 56060, Australia; Not yet recruiting GSK Clinical Trials Call Center 1-877-379-3718 lcallaway@invclinic.com.au GSK Clinical Trials Call Center, Queensland, 40000, Australia; Not yet recruiting GSK Clinical Trials Call Center 1-877-379-3718 brisbane_medical_research@hotmail.com