A 1-Year, Randomized, Double-Blind, Placebo-Controlled Phase 3 Study To Evaluate The Efficacy And Safety Of CP-945,598 In The Treatment Of Overweight, Oral Agent-Treated Subjects With Type 2 Diabetes Mellitus

简要总结

详细描述

主要结局

次要结局

• Change from baseline in laboratory tests and ECGs at 1 year; vitals signs at (at Week 2, Months 1 - 6, 9, 11 and 1 year) and adverse events;(1 year)
• Proportion of subjects who lose 5 and 10% baseline body weight at 1 year;(1 year)
• Proportion of subjects achieving HbA1c <6.5% and <7% at 1 year;(1 year)
• Change from baseline in waist circumference at 1 year;(1 year)
• Change from baseline fasting triglyceride and HDL concentrations at 1 year;(1 year)
• Change from baseline in Total cholesterol, LDL, TNF α, adiponectin, and hsCRP levels at month 6 and 1 year;(1 year)
• Change in prevalence of metabolic syndrome based on accepted definition at the time of study completion;(1 year)
• HOMA IR (HOMA IR=fasting insulin x fasting glucose/22.5) at 1 year;(1 year)
• Percentage of subjects who require additional diabetes pharmacotherapy because they meet protocol criteria for inadequate glycemic control;(1 year)
• Population pharmacokinetic analysis of data acquired at trough and by randomized sparse sampling and exploration of PK/PD relationships;(1 year)
• Change from baseline fasting plasma glucose concentration at 1 year;(1 year)
• Change from baseline in Patient Health Questionnaire 9 and Generalized Anxiety Disorder 7 scores at months 1, 2, 3, 5, 6, 9, and 1 year;(1 year)
• Change from baseline in background sulfonylurea or meglitinide dose requirements in subjects taking these medications;(1 year)
• Change from baseline in 7 point home glucose profiles in a subset of subjects at 1 year;(1 year)
• Primary and key secondary endpoints at any measured intermediate time points including weight at week 2, months 1, 6, 9, and 11;(1 year)
• HbA1c, fasting plasma glucose at months 1, 3, 6, and 9;(1 year)
• Waist circumference at months 3, 6, and 9;(1 year)
• Fasting triglyceride and HDL concentrations at month 6 and patient reported outcome subscales: uncontrolled eating/hunger, power of food, physical functioning, and self esteem at months 3 and 6;(1 year)
• Change in fasting and postprandial insulin concentrations determined from OGTT in a subset of subjects at 1 year;(1 year)
• Protocol defined hypoglycemia event rates and proportion of subjects with hypoglycemic events;(1 year)
• Change from baseline postprandial glucose determined from OGTT in a subset of subjects at 1 year;(1 year)
• Changes from baseline in patient reported outcome subscales: uncontrolled eating/hunger, power of food, physical functioning, and self esteem at 1 year;(1 year)
• Changes in patient reported outcome subscales not identified as key secondary endpoints at months 3, 6, and 12(1 year)
• Change from baseline HbA1c to 1 year;(1 year)