Study In People With Type 2 Diabetes
This Phase 2 dose-ranging study will evaluate the efficacy, safety and tolerability of a range of doses of GW677954 compared with placebo over sixteen weeks of treatment in subjects with T2DM (Type 2 Diabetes Mellitus).
Diabetes Mellitus, Type 2
Non-Insulin-Dependent Diabetes Mellitus
|Study Design:||Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Primary Purpose: Treatment
|Official Title:||See Detailed Description|
- Improvement in glucose control over a 16 week period. [ Time Frame: 16 weeks ]
- Cholesterol, additional glycemic endpoints, safety endpoints [ Time Frame: 16 Weeks ]
- Glycemia Change from baseline in fasting HbA1c levels at Weeks 4, 8 and 12. Change from baseline in fasting FPG at Weeks 1, 2, 4, 6, 8, 12 and 16. Statistical testing will only be performed at Week 16.
- Change from baseline in fasting fructosamine at Weeks 2 and 4. Proportion of subjects achieving target HbA1c levels (≤ 7%) at Weeks 4, 8, 12 and 16.
- Proportion of subjects achieving a decrease in HbA1c of ≥0.7% from baseline at Weeks 4, 8, 12 and 16.
- Proportion of subjects achieving target FPG (≤126 mg/dL [7.0 mmol/L] and≤140 mg/dL [7.8 mmol/L]) at Weeks 1, 2, 4, 6, 8, 12 and 16. Proportion of subjects achieving a decrease in FPG of ≥30 mg/dL [1.66 mmol/L] at Weeks 1, 2, 4, 6, 8, 12 and 16.
- Lipids Percentage change from baseline in TC, HDL-C, LDL-C, TGs and FFAs based on log-transformed data at Weeks 2, 4, 8, 12 and 16. Percentage change from baseline in non-HDL-C based on log-transformed data at Week 16.
- Percentage change from baseline in VLDL-C, apo AI, AII and B at Week 16. Change from baseline in Apo B/TC, TC/HDL-C and LDL-C/Apo B ratio at relevant timepoints.
- Secondary Safety Endpoints Safety and tolerability, assessed by incidence of AEs over the course of the study. Change from baseline in levels of hematocrit and hemoglobin.
- Change from baseline in vital signs including blood pressure and heart rate measurements in the sitting position. Change from baseline in body weight and waist circumference.
- Change from baseline in 12 lead ECG. Measures include PR, QT and QTc intervals and QRS duration.
- Clinical laboratory tests including full blood counts, chemistry, urinalysis, exploratory cardiac biomarkers and serum pregnancy tests.
- Ophthalmic assessments. Incidence and severity of hypoglycemia.
|Study Start Date:||September 2005|
|Study Completion Date:||October 2007|
|Primary Completion Date:||October 2007 (Final data collection date for primary outcome measure)|
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
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|Study Director:||GSK Clinical Trials||GlaxoSmithKline|