Clinical trial NCT00542009: A Trial In Diabetic Patients To Assess Effect Of CE-326,597 On Glucose Control And Body Weight
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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Weight Management
Treatment Of Obesity
Keywords: Phase 2A, safety and efficacy trial with CE-326,597 in patients with T2DM.
Lead sponsor: Pfizer
Sponsor class: INDUSTRY
First posted: 2007-10-10
Enrollment: 252
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: Study of whether the investigational drug CE-326,597 improves glucose control and results in body weight loss in patients with type 2 diabetes


Eligibility criteria: 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

Primary outcomes:
measure: Glucose control
timeFrame: At Day 84
measure: Body weight
timeFrame: At Day 84
Secondary outcomes:
measure: Regimen (dose or number) of anti-diabetic agents
timeFrame: At Day 84
measure: GlycoMark
timeFrame: On Day 84
measure: Waist circumference
timeFrame: On Day 84
measure: Proportion of subjects who achieve HbA1C <7% and <6.5%
timeFrame: On Day 84
measure: 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.
timeFrame: Throughout Study
measure: Standard safety (via AEs, SAEs, vitals, 12-lead ECG, abdominal ultrasound) will be monitored throughout the trial.
timeFrame: Throughout Study
measure: Change in following parameters: Post-prandial and fasting glucose, and insulin
timeFrame: On Day 28
Other outcomes:
Locations:
city: Phoenix
country: United States
facility: Pfizer Investigational Site
state: Arizona
city: Fresno
country: United States
facility: Pfizer Investigational Site
state: California
city: National City
country: United States
facility: Pfizer Investigational Site
state: California
city: San Diego
country: United States
facility: Pfizer Investigational Site
state: California
city: Miami
country: United States
facility: Pfizer Investigational Site
state: Florida
city: Ocala
country: United States
facility: Pfizer Investigational Site
state: Florida
city: West Palm Beach
country: United States
facility: Pfizer Investigational Site
state: Florida
city: Atlanta
country: United States
facility: Pfizer Investigational Site
state: Georgia
city: Conyers
country: United States
facility: Pfizer Investigational Site
state: Georgia
city: Honolulu
country: United States
facility: Pfizer Investigational Site
state: Hawaii
city: Idaho Falls
country: United States
facility: Pfizer Investigational Site
state: Idaho
city: Chicago
country: United States
facility: Pfizer Investigational Site
state: Illinois
city: Chicago
country: United States
facility: Pfizer Investigational Site
state: Illinois
city: Overland Park
country: United States
facility: Pfizer Investigational Site
state: Kansas
city: Bethesda
country: United States
facility: Pfizer Investigational Site
state: Maryland
city: Chaska
country: United States
facility: Pfizer Investigational Site
state: Minnesota
city: Minneapolis
country: United States
facility: Pfizer Investigational Site
state: Minnesota
city: Jackson
country: United States
facility: Pfizer Investigational Site
state: Mississippi
city: Henderson
country: United States
facility: Pfizer Investigational Site
state: Nevada
city: Las Vegas
country: United States
facility: Pfizer Investigational Site
state: Nevada
city: Las Vegas
country: United States
facility: Pfizer Investigational Site
state: Nevada
city: Fargo
country: United States
facility: Pfizer Investigational Site
state: North Dakota
city: Cincinnati
country: United States
facility: Pfizer Investigational Site
state: Ohio
city: Lansdale
country: United States
facility: Pfizer Investigational Site
state: Pennsylvania
city: Rapid City
country: United States
facility: Pfizer Investigational Site
state: South Dakota
city: Beaumont
country: United States
facility: Pfizer Investigational Site
state: Texas
city: Beaumont
country: United States
facility: Pfizer Investigational Site
state: Texas
city: Dallas
country: United States
facility: Pfizer Investigational Site
state: Texas
city: Dallas
country: United States
facility: Pfizer Investigational Site
state: Texas
city: Richmond
country: United States
facility: Pfizer Investigational Site
state: Virginia
city: Pleven
country: Bulgaria
facility: Pfizer Investigational Site
city: Sofia
country: Bulgaria
facility: Pfizer Investigational Site
city: Sofia
country: Bulgaria
facility: Pfizer Investigational Site
city: Stara Zagora
country: Bulgaria
facility: Pfizer Investigational Site
city: Coquitlam
country: Canada
facility: Pfizer Investigational Site
state: British Columbia
city: Winnipeg
country: Canada
facility: Pfizer Investigational Site
state: Manitoba
city: Winnipeg
country: Canada
facility: Pfizer Investigational Site
state: Manitoba
city: London
country: Canada
facility: Pfizer Investigational Site
state: Ontario
city: Laval
country: Canada
facility: Pfizer Investigational Site
state: Quebec
city: Montreal
country: Canada
facility: Pfizer Investigational Site
state: Quebec
city: Bangalore
country: India
facility: Pfizer Investigational Site
state: Karnataka
city: Indore
country: India
facility: Pfizer Investigational Site
state: Madhya Pradesh
city: Nagpur
country: India
facility: Pfizer Investigational Site
state: Maharashtra
city: Nasik
country: India
facility: Pfizer Investigational Site
state: Maharashtra
city: Ladron de Guevara
country: Mexico
facility: Pfizer Investigational Site
state: Guadalajara, Jalisco
city: Guadalajara
country: Mexico
facility: Pfizer Investigational Site
state: Jalisco
city: Monterrey
country: Mexico
facility: Pfizer Investigational Site
state: Nuevo Leon
city: Ponce
country: Puerto Rico
facility: Pfizer Investigational Site
city: San Juan
country: Puerto Rico
facility: Pfizer Investigational Site
city: Tao Baja
country: Puerto Rico
facility: Pfizer Investigational Site
city: Santiago de Compostela
country: Spain
facility: Pfizer Investigational Site
state: La Coruña
city: Barcelona
country: Spain
facility: Pfizer Investigational Site
city: Madrid
country: Spain
facility: Pfizer Investigational Site
city: Sevilla
country: Spain
facility: Pfizer Investigational Site
Study officials:
affiliation: Pfizer
name: Pfizer CT.gov Call Center
role: STUDY_DIRECTOR
References: