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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT00542009
Other study ID # A7211005
Secondary ID
Status Completed
Phase Phase 2
First received October 5, 2007
Last updated November 5, 2012
Start date December 2007
Est. completion date November 2008

Study information

Verified date November 2012
Source Pfizer
Contact n/a
Is FDA regulated No
Health authority United States: Food and Drug Administration
Study type Interventional

Clinical Trial 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


Recruitment information / eligibility

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

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator), Primary Purpose: Treatment


Related Conditions & MeSH terms


Intervention

Drug:
CE-326,597 100 mg QD
Administered orally, once daily with morning meal for duration of trial (84 days).
CE-326,597 50 mg QD
Administered orally, once daily with morning meal for duration of trial (84 days).
CE-326,597 25 mg QD
Administered orally, once daily with morning meal for duration of trial (84 days).
Placebo
Placebo to match CE-326,597 tablets to be administered orally, once daily with morning meal for duration of trial (84 days).
CE-326,597 5mg QD
Administered orally, once daily with morning meal for duration of trial (84 days).

Locations

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

Sponsors (1)

Lead Sponsor Collaborator
Pfizer

Countries where clinical trial is conducted

United States,  Bulgaria,  Canada,  India,  Mexico,  Puerto Rico,  Spain, 

Outcome

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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