Study of whether the investigational drug CE-326,597 improves glucose control and results in body weight loss in patients with type 2 diabetes
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Enrollment
252
Administered orally, once daily with morning meal for duration of trial (84 days).
Administered orally, once daily with morning meal for duration of trial (84 days).
Administered orally, once daily with morning meal for duration of trial (84 days).
Glucose control
Time frame: At Day 84
Body weight
Time frame: At Day 84
Regimen (dose or number) of anti-diabetic agents
Time frame: At Day 84
GlycoMark
Time frame: On Day 84
Waist circumference
Time frame: On Day 84
Proportion of subjects who achieve HbA1C <7% and <6.5%
Time frame: On Day 84
Population PK to analyze CE-326,597 concentrations as well as explore relationship of concentration to effect on HbA1C and body weight over duration of trial.
Time frame: Throughout Study
Standard safety (via AEs, SAEs, vitals, 12-lead ECG, abdominal ultrasound) will be monitored throughout the trial.
Time frame: Throughout Study
Change in following parameters: Post-prandial and fasting glucose, and insulin
Time frame: On Day 28
This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.
Placebo to match CE-326,597 tablets to be administered orally, once daily with morning meal for duration of trial (84 days).
Administered orally, once daily with morning meal for duration of trial (84 days).
Pfizer Investigational Site
Phoenix, Arizona, United States
Pfizer Investigational Site
Fresno, California, United States
Pfizer Investigational Site
National City, California, United States
Pfizer Investigational Site
San Diego, California, United States
Pfizer Investigational Site
Miami, Florida, United States
Pfizer Investigational Site
Ocala, Florida, United States
Pfizer Investigational Site
West Palm Beach, Florida, United States
Pfizer Investigational Site
Atlanta, Georgia, United States
Pfizer Investigational Site
Conyers, Georgia, United States
Pfizer Investigational Site
Honolulu, Hawaii, United States
...and 44 more locations