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Clinical Trial Details

Trial ID: L6194
Source ID: NCT00542009
Associated Drug: Ce-326,597 100 Mg Qd
Title: A Trial In Diabetic Patients To Assess Effect Of CE-326,597 On Glucose Control And Body Weight
Acronym:
Status: COMPLETED
Study Results: NO
Results:
Conditions: Weight Management|Treatment Of Obesity
Interventions: DRUG: CE-326,597 100 mg QD|DRUG: CE-326,597 50 mg QD|DRUG: CE-326,597 25 mg QD|DRUG: Placebo|DRUG: CE-326,597 5mg QD
Outcome Measures: Primary: Glucose control, At Day 84|Body weight, At Day 84 | Secondary: Regimen (dose or number) of anti-diabetic agents, At Day 84|GlycoMark, On Day 84|Waist circumference, On Day 84|Proportion of subjects who achieve HbA1C <7% and <6.5%, 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., Throughout Study|Standard safety (via AEs, SAEs, vitals, 12-lead ECG, abdominal ultrasound) will be monitored throughout the trial., Throughout Study|Change in following parameters: Post-prandial and fasting glucose, and insulin, On Day 28
Sponsor/Collaborators: Sponsor: Pfizer
Gender: ALL
Age: ADULT, OLDER_ADULT
Phases: PHASE2
Enrollment: 252
Study Type: INTERVENTIONAL
Study Designs: Allocation: RANDOMIZED|Intervention Model: PARALLEL|Masking: DOUBLE (PARTICIPANT, INVESTIGATOR)|Primary Purpose: TREATMENT
Start Date: 2007-12
Completion Date: 2008-11
Results First Posted:
Last Update Posted: 2012-11-07
Locations: Pfizer Investigational Site, Phoenix, Arizona, 85023, United States|Pfizer Investigational Site, Fresno, California, 93720, United States|Pfizer Investigational Site, National City, California, 91950, United States|Pfizer Investigational Site, San Diego, California, 92128, United States|Pfizer Investigational Site, Miami, Florida, 33143, United States|Pfizer Investigational Site, Ocala, Florida, 34471, United States|Pfizer Investigational Site, West Palm Beach, Florida, 33401, United States|Pfizer Investigational Site, Atlanta, Georgia, 30342, United States|Pfizer Investigational Site, Conyers, Georgia, 30094, United States|Pfizer Investigational Site, Honolulu, Hawaii, 96814, United States|Pfizer Investigational Site, Idaho Falls, Idaho, 83404, United States|Pfizer Investigational Site, Chicago, Illinois, 60607, United States|Pfizer Investigational Site, Chicago, Illinois, 60654, United States|Pfizer Investigational Site, Overland Park, Kansas, 66212, United States|Pfizer Investigational Site, Bethesda, Maryland, 20817, United States|Pfizer Investigational Site, Chaska, Minnesota, 55318, United States|Pfizer Investigational Site, Minneapolis, Minnesota, 55455, United States|Pfizer Investigational Site, Jackson, Mississippi, 39202, United States|Pfizer Investigational Site, Henderson, Nevada, 89052, United States|Pfizer Investigational Site, Las Vegas, Nevada, 89101, United States|Pfizer Investigational Site, Las Vegas, Nevada, 89117, United States|Pfizer Investigational Site, Fargo, North Dakota, 58103, United States|Pfizer Investigational Site, Cincinnati, Ohio, 45249, United States|Pfizer Investigational Site, Lansdale, Pennsylvania, 19446, United States|Pfizer Investigational Site, Rapid City, South Dakota, 57702, United States|Pfizer Investigational Site, Beaumont, Texas, 77701, United States|Pfizer Investigational Site, Beaumont, Texas, 77706, United States|Pfizer Investigational Site, Dallas, Texas, 75231, United States|Pfizer Investigational Site, Dallas, Texas, 75246, United States|Pfizer Investigational Site, Richmond, Virginia, 23294, United States|Pfizer Investigational Site, Pleven, 5800, Bulgaria|Pfizer Investigational Site, Sofia, 1431, Bulgaria|Pfizer Investigational Site, Sofia, 1606, Bulgaria|Pfizer Investigational Site, Stara Zagora, 6000, Bulgaria|Pfizer Investigational Site, Coquitlam, British Columbia, V3K 3P4, Canada|Pfizer Investigational Site, Winnipeg, Manitoba, R3a 1R9, Canada|Pfizer Investigational Site, Winnipeg, Manitoba, R3E 3P4, Canada|Pfizer Investigational Site, London, Ontario, N6A 4V2, Canada|Pfizer Investigational Site, Laval, Quebec, H7T 2P5, Canada|Pfizer Investigational Site, Montreal, Quebec, H3A 1A1, Canada|Pfizer Investigational Site, Bangalore, Karnataka, 560 052, India|Pfizer Investigational Site, Indore, Madhya Pradesh, 452 001, India|Pfizer Investigational Site, Nagpur, Maharashtra, 440 012, India|Pfizer Investigational Site, Nasik, Maharashtra, 422 013, India|Pfizer Investigational Site, Ladron de Guevara, Guadalajara, Jalisco, 44656, Mexico|Pfizer Investigational Site, Guadalajara, Jalisco, 44340, Mexico|Pfizer Investigational Site, Monterrey, Nuevo Leon, 64460, Mexico|Pfizer Investigational Site, Ponce, 00716, Puerto Rico|Pfizer Investigational Site, San Juan, 00909, Puerto Rico|Pfizer Investigational Site, Tao Baja, 00949, Puerto Rico|Pfizer Investigational Site, Santiago de Compostela, La Coruña, 15706, Spain|Pfizer Investigational Site, Barcelona, 08036, Spain|Pfizer Investigational Site, Madrid, 28040, Spain|Pfizer Investigational Site, Sevilla, 41013, Spain
URL: https://clinicaltrials.gov/show/NCT00542009

Drug ID Drug Name Type DrugBank ID Targets Category Latest Progress