A New Oral Treatment For Type II Diabetes Mellitus
This is a 24-week study investigating the safety and efficacy of several dosages of a potential new oral medicine for Type II diabetes mellitus.
|Study Design:||Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Primary Purpose: Treatment
|Official Title:||See Detailed Description|
- Change from baseline in HbA1c at Week 12.
- Change in HbA1c, FPG, fructosamine, insulin, pro-insulin, ECG, vital signs, BMI, waist/ hip circumference and weight.
- Proportion of subjects who achieve predefined decreases or targets in HBA1c and FPG. PopPK. AEs, hypos and lab measures.
|Study Start Date:||April 2005|
|Study Completion Date:||July 2006|
|Primary Completion Date:||July 2006 (Final data collection date for primary outcome measure)|
A 12-Week, Parallel-Group, Double-Blind, Randomized, Placebo-Controlled, Multicenter, Dose Ranging Study to Evaluate the Efficacy, Safety and Tolerability of GW823093, Administered Orally, Once Daily, as Monotherapy in Subjects With Type 2 Diabetes Mellitus followed by a 12-week Active Treatment Extension
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|Study Director:||GSK Clinical Trials, MD||GlaxoSmithKline|