A Trial In Diabetic Patients To Assess Effect Of CE-326,597 On Glucose Control And Body Weight

November 5, 2012 updated by: Pfizer

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

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

252

Phase

  • Phase 2

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Bulgaria
      • Pleven, Bulgaria, 5800
        • Pfizer Investigational Site
      • Sofia, Bulgaria, 1431
        • Pfizer Investigational Site
      • Sofia, Bulgaria, 1606
        • Pfizer Investigational Site
      • Stara Zagora, Bulgaria, 6000
        • Pfizer Investigational Site
  • Canada
    • British Columbia
      • Coquitlam, British Columbia, Canada, V3K 3P4
        • Pfizer Investigational Site
    • Manitoba
      • Winnipeg, Manitoba, Canada, R3A 1R9
        • Pfizer Investigational Site
      • Winnipeg, Manitoba, Canada, R3E 3P4
        • Pfizer Investigational Site
    • Ontario
      • London, Ontario, Canada, N6A 4V2
        • Pfizer Investigational Site
    • Quebec
      • Laval, Quebec, Canada, H7T 2P5
        • Pfizer Investigational Site
      • Montreal, Quebec, Canada, H3A 1A1
        • Pfizer Investigational Site
  • India
    • Karnataka
      • Bangalore, Karnataka, India, 560 052
        • Pfizer Investigational Site
    • Madhya Pradesh
      • Indore, Madhya Pradesh, India, 452 001
        • Pfizer Investigational Site
    • Maharashtra
      • Nagpur, Maharashtra, India, 440 012
        • Pfizer Investigational Site
      • Nasik, Maharashtra, India, 422 013
        • Pfizer Investigational Site
  • Mexico
    • Guadalajara, Jalisco
      • Ladron de Guevara, Guadalajara, Jalisco, Mexico, 44656
        • Pfizer Investigational Site
    • Jalisco
      • Guadalajara, Jalisco, Mexico, 44340
        • Pfizer Investigational Site
    • Nuevo Leon
      • Monterrey, Nuevo Leon, Mexico, 64460
        • Pfizer Investigational Site
  • Puerto Rico
      • Ponce, Puerto Rico, 00716
        • Pfizer Investigational Site
      • San Juan, Puerto Rico, 00909
        • Pfizer Investigational Site
      • Tao Baja, Puerto Rico, 00949
        • Pfizer Investigational Site
  • Spain
      • Barcelona, Spain, 08036
        • Pfizer Investigational Site
      • Madrid, Spain, 28040
        • Pfizer Investigational Site
      • Sevilla, Spain, 41013
        • Pfizer Investigational Site
    • La Coruña
      • Santiago de Compostela, La Coruña, Spain, 15706
        • Pfizer Investigational Site
  • United States
    • Arizona
      • Phoenix, Arizona, United States, 85023
        • Pfizer Investigational Site
    • California
      • Fresno, California, United States, 93720
        • Pfizer Investigational Site
      • National City, California, United States, 91950
        • Pfizer Investigational Site
      • San Diego, California, United States, 92128
        • Pfizer Investigational Site
    • Florida
      • Miami, Florida, United States, 33143
        • Pfizer Investigational Site
      • Ocala, Florida, United States, 34471
        • Pfizer Investigational Site
      • West Palm Beach, Florida, United States, 33401
        • Pfizer Investigational Site
    • Georgia
      • Atlanta, Georgia, United States, 30342
        • Pfizer Investigational Site
      • Conyers, Georgia, United States, 30094
        • Pfizer Investigational Site
    • Hawaii
      • Honolulu, Hawaii, United States, 96814
        • Pfizer Investigational Site
    • Idaho
      • Idaho Falls, Idaho, United States, 83404
        • Pfizer Investigational Site
    • Illinois
      • Chicago, Illinois, United States, 60607
        • Pfizer Investigational Site
      • Chicago, Illinois, United States, 60654
        • Pfizer Investigational Site
    • Kansas
      • Overland Park, Kansas, United States, 66212
        • Pfizer Investigational Site
    • Maryland
      • Bethesda, Maryland, United States, 20817
        • Pfizer Investigational Site
    • Minnesota
      • Chaska, Minnesota, United States, 55318
        • Pfizer Investigational Site
      • Minneapolis, Minnesota, United States, 55455
        • Pfizer Investigational Site
    • Mississippi
      • Jackson, Mississippi, United States, 39202
        • Pfizer Investigational Site
    • Nevada
      • Henderson, Nevada, United States, 89052
        • Pfizer Investigational Site
      • Las Vegas, Nevada, United States, 89117
        • Pfizer Investigational Site
      • Las Vegas, Nevada, United States, 89101
        • Pfizer Investigational Site
    • North Dakota
      • Fargo, North Dakota, United States, 58103
        • Pfizer Investigational Site
    • Ohio
      • Cincinnati, Ohio, United States, 45249
        • Pfizer Investigational Site
    • Pennsylvania
      • Lansdale, Pennsylvania, United States, 19446
        • Pfizer Investigational Site
    • South Dakota
      • Rapid City, South Dakota, United States, 57702
        • Pfizer Investigational Site
    • Texas
      • Beaumont, Texas, United States, 77701
        • Pfizer Investigational Site
      • Beaumont, Texas, United States, 77706
        • Pfizer Investigational Site
      • Dallas, Texas, United States, 75231
        • Pfizer Investigational Site
      • Dallas, Texas, United States, 75246
        • Pfizer Investigational Site
    • Virginia
      • Richmond, Virginia, United States, 23294
        • Pfizer Investigational Site

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 65 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Double

Arms and Interventions

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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Glucose control
Time Frame: At Day 84
At Day 84
Body weight
Time Frame: At Day 84
At Day 84

Secondary Outcome Measures

Outcome Measure
Time Frame
Regimen (dose or number) of anti-diabetic agents
Time Frame: At Day 84
At Day 84
GlycoMark
Time Frame: On Day 84
On Day 84
Waist circumference
Time Frame: On Day 84
On Day 84
Proportion of subjects who achieve HbA1C <7% and <6.5%
Time Frame: On Day 84
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
Throughout Study
Standard safety (via AEs, SAEs, vitals, 12-lead ECG, abdominal ultrasound) will be monitored throughout the trial.
Time Frame: Throughout Study
Throughout Study
Change in following parameters: Post-prandial and fasting glucose, and insulin
Time Frame: On Day 28
On Day 28

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Pfizer

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

December 1, 2007

Primary Completion (Actual)

November 1, 2008

Study Completion (Actual)

November 1, 2008

Study Registration Dates

First Submitted

October 5, 2007

First Submitted That Met QC Criteria

October 5, 2007

First Posted (Estimate)

October 10, 2007

Study Record Updates

Last Update Posted (Estimate)

November 7, 2012

Last Update Submitted That Met QC Criteria

November 5, 2012

Last Verified

November 1, 2012

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • A7211005

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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