Weight Management Clinical Trial
Official title:
A 12-Week, Phase 2A, Randomized, Subject And Investigator Blinded, Placebo-Controlled Trial To Evaluate The Safety, Tolerability And Efficacy Of CE-326,597 On Glucose Control And Body Weight In Overweight Adult Subjects With Type 2 Diabetes Mellitus
| Verified date | November 2012 |
| Source | Pfizer |
| Contact | n/a |
| Is FDA regulated | No |
| Health authority | United States: Food and Drug Administration |
| Study type | Interventional |
Study of whether the investigational drug CE-326,597 improves glucose control and results in body weight loss in patients with type 2 diabetes
| Status | Completed |
| Enrollment | 252 |
| Est. completion date | November 2008 |
| Est. primary completion date | November 2008 |
| Accepts healthy volunteers | No |
| Gender | Both |
| Age group | 18 Years to 65 Years |
| Eligibility |
Inclusion Criteria: Patients with type 2 diabetes, not on any or on oral (up to 2) anti-diabetic medications, otherwise medically stable. Exclusion Criteria: Women of childbearing potential, people with unstable medical conditions, people with gallstones |
Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator), Primary Purpose: Treatment
| Country | Name | City | State |
|---|---|---|---|
| Bulgaria | Pfizer Investigational Site | Pleven | |
| Bulgaria | Pfizer Investigational Site | Sofia | |
| Bulgaria | Pfizer Investigational Site | Sofia | |
| Bulgaria | Pfizer Investigational Site | Stara Zagora | |
| Canada | Pfizer Investigational Site | Coquitlam | British Columbia |
| Canada | Pfizer Investigational Site | Laval | Quebec |
| Canada | Pfizer Investigational Site | London | Ontario |
| Canada | Pfizer Investigational Site | Montreal | Quebec |
| Canada | Pfizer Investigational Site | Winnipeg | Manitoba |
| Canada | Pfizer Investigational Site | Winnipeg | Manitoba |
| India | Pfizer Investigational Site | Bangalore | Karnataka |
| India | Pfizer Investigational Site | Indore | Madhya Pradesh |
| India | Pfizer Investigational Site | Nagpur | Maharashtra |
| India | Pfizer Investigational Site | Nasik | Maharashtra |
| Mexico | Pfizer Investigational Site | Guadalajara | Jalisco |
| Mexico | Pfizer Investigational Site | Ladron de Guevara | Guadalajara, Jalisco |
| Mexico | Pfizer Investigational Site | Monterrey | Nuevo Leon |
| Puerto Rico | Pfizer Investigational Site | Ponce | |
| Puerto Rico | Pfizer Investigational Site | San Juan | |
| Puerto Rico | Pfizer Investigational Site | Tao Baja | |
| Spain | Pfizer Investigational Site | Barcelona | |
| Spain | Pfizer Investigational Site | Madrid | |
| Spain | Pfizer Investigational Site | Santiago de Compostela | La Coruña |
| Spain | Pfizer Investigational Site | Sevilla | |
| United States | Pfizer Investigational Site | Atlanta | Georgia |
| United States | Pfizer Investigational Site | Beaumont | Texas |
| United States | Pfizer Investigational Site | Beaumont | Texas |
| United States | Pfizer Investigational Site | Bethesda | Maryland |
| United States | Pfizer Investigational Site | Chaska | Minnesota |
| United States | Pfizer Investigational Site | Chicago | Illinois |
| United States | Pfizer Investigational Site | Chicago | Illinois |
| United States | Pfizer Investigational Site | Cincinnati | Ohio |
| United States | Pfizer Investigational Site | Conyers | Georgia |
| United States | Pfizer Investigational Site | Dallas | Texas |
| United States | Pfizer Investigational Site | Dallas | Texas |
| United States | Pfizer Investigational Site | Fargo | North Dakota |
| United States | Pfizer Investigational Site | Fresno | California |
| United States | Pfizer Investigational Site | Henderson | Nevada |
| United States | Pfizer Investigational Site | Honolulu | Hawaii |
| United States | Pfizer Investigational Site | Idaho Falls | Idaho |
| United States | Pfizer Investigational Site | Jackson | Mississippi |
| United States | Pfizer Investigational Site | Lansdale | Pennsylvania |
| United States | Pfizer Investigational Site | Las Vegas | Nevada |
| United States | Pfizer Investigational Site | Las Vegas | Nevada |
| United States | Pfizer Investigational Site | Miami | Florida |
| United States | Pfizer Investigational Site | Minneapolis | Minnesota |
| United States | Pfizer Investigational Site | National City | California |
| United States | Pfizer Investigational Site | Ocala | Florida |
| United States | Pfizer Investigational Site | Overland Park | Kansas |
| United States | Pfizer Investigational Site | Phoenix | Arizona |
| United States | Pfizer Investigational Site | Rapid City | South Dakota |
| United States | Pfizer Investigational Site | Richmond | Virginia |
| United States | Pfizer Investigational Site | San Diego | California |
| United States | Pfizer Investigational Site | West Palm Beach | Florida |
| Lead Sponsor | Collaborator |
|---|---|
| Pfizer |
United States, Bulgaria, Canada, India, Mexico, Puerto Rico, Spain,
| Type | Measure | Description | Time frame | Safety issue |
|---|---|---|---|---|
| Primary | Glucose control | At Day 84 | No | |
| Primary | Body weight | At Day 84 | No | |
| Secondary | Regimen (dose or number) of anti-diabetic agents | At Day 84 | No | |
| Secondary | GlycoMark | On Day 84 | No | |
| Secondary | Waist circumference | On Day 84 | No | |
| Secondary | Proportion of subjects who achieve HbA1C <7% and <6.5% | On Day 84 | No | |
| Secondary | 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 | No | |
| Secondary | Standard safety (via AEs, SAEs, vitals, 12-lead ECG, abdominal ultrasound) will be monitored throughout the trial. | Throughout Study | Yes | |
| Secondary | Change in following parameters: Post-prandial and fasting glucose, and insulin | On Day 28 | No |
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