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

Primary Purpose

Weight Management, Treatment Of Obesity

Status
Completed
Phase
Phase 2
Locations
International
Study Type
Interventional
Intervention
CE-326,597 100 mg QD
CE-326,597 50 mg QD
CE-326,597 25 mg QD
Placebo
CE-326,597 5mg QD
Sponsored by
Pfizer
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Weight Management focused on measuring Phase 2A, safety and efficacy trial with CE-326,597 in patients with T2DM.

Eligibility Criteria

18 Years - 65 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Pfizer Investigational Site
  • Pfizer Investigational Site
  • Pfizer Investigational Site
  • Pfizer Investigational Site
  • Pfizer Investigational Site
  • Pfizer Investigational Site
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  • Pfizer Investigational Site
  • Pfizer Investigational Site

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm 4

Arm 5

Arm Type

Experimental

Experimental

Experimental

Placebo Comparator

Experimental

Arm Label

CE-326,597 100 mg QD

CE-326,597 50 mg QD

CE-326,597 25 mg QD

Placebo

CE-326,597 5mg QD

Arm Description

Outcomes

Primary Outcome Measures

Glucose control
Body weight

Secondary Outcome Measures

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

Full Information

First Posted
October 5, 2007
Last Updated
November 5, 2012
Sponsor
Pfizer
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1. Study Identification

Unique Protocol Identification Number
NCT00542009
Brief Title
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

2. Study Status

Record Verification Date
November 2012
Overall Recruitment Status
Completed
Study Start Date
December 2007 (undefined)
Primary Completion Date
November 2008 (Actual)
Study Completion Date
November 2008 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Pfizer

4. Oversight

Data Monitoring Committee
No

5. Study Description

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

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Weight Management, Treatment Of Obesity
Keywords
Phase 2A, safety and efficacy trial with CE-326,597 in patients with T2DM.

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Parallel Assignment
Masking
ParticipantInvestigator
Allocation
Randomized
Enrollment
252 (Actual)

8. Arms, Groups, and Interventions

Arm Title
CE-326,597 100 mg QD
Arm Type
Experimental
Arm Title
CE-326,597 50 mg QD
Arm Type
Experimental
Arm Title
CE-326,597 25 mg QD
Arm Type
Experimental
Arm Title
Placebo
Arm Type
Placebo Comparator
Arm Title
CE-326,597 5mg QD
Arm Type
Experimental
Intervention Type
Drug
Intervention Name(s)
CE-326,597 100 mg QD
Intervention Description
Administered orally, once daily with morning meal for duration of trial (84 days).
Intervention Type
Drug
Intervention Name(s)
CE-326,597 50 mg QD
Intervention Description
Administered orally, once daily with morning meal for duration of trial (84 days).
Intervention Type
Drug
Intervention Name(s)
CE-326,597 25 mg QD
Intervention Description
Administered orally, once daily with morning meal for duration of trial (84 days).
Intervention Type
Drug
Intervention Name(s)
Placebo
Intervention Description
Placebo to match CE-326,597 tablets to be administered orally, once daily with morning meal for duration of trial (84 days).
Intervention Type
Drug
Intervention Name(s)
CE-326,597 5mg QD
Intervention Description
Administered orally, once daily with morning meal for duration of trial (84 days).
Primary Outcome Measure Information:
Title
Glucose control
Time Frame
At Day 84
Title
Body weight
Time Frame
At Day 84
Secondary Outcome Measure Information:
Title
Regimen (dose or number) of anti-diabetic agents
Time Frame
At Day 84
Title
GlycoMark
Time Frame
On Day 84
Title
Waist circumference
Time Frame
On Day 84
Title
Proportion of subjects who achieve HbA1C <7% and <6.5%
Time Frame
On Day 84
Title
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
Title
Standard safety (via AEs, SAEs, vitals, 12-lead ECG, abdominal ultrasound) will be monitored throughout the trial.
Time Frame
Throughout Study
Title
Change in following parameters: Post-prandial and fasting glucose, and insulin
Time Frame
On Day 28

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
No
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Pfizer CT.gov Call Center
Organizational Affiliation
Pfizer
Official's Role
Study Director
Facility Information:
Facility Name
Pfizer Investigational Site
City
Phoenix
State/Province
Arizona
ZIP/Postal Code
85023
Country
United States
Facility Name
Pfizer Investigational Site
City
Fresno
State/Province
California
ZIP/Postal Code
93720
Country
United States
Facility Name
Pfizer Investigational Site
City
National City
State/Province
California
ZIP/Postal Code
91950
Country
United States
Facility Name
Pfizer Investigational Site
City
San Diego
State/Province
California
ZIP/Postal Code
92128
Country
United States
Facility Name
Pfizer Investigational Site
City
Miami
State/Province
Florida
ZIP/Postal Code
33143
Country
United States
Facility Name
Pfizer Investigational Site
City
Ocala
State/Province
Florida
ZIP/Postal Code
34471
Country
United States
Facility Name
Pfizer Investigational Site
City
West Palm Beach
State/Province
Florida
ZIP/Postal Code
33401
Country
United States
Facility Name
Pfizer Investigational Site
City
Atlanta
State/Province
Georgia
ZIP/Postal Code
30342
Country
United States
Facility Name
Pfizer Investigational Site
City
Conyers
State/Province
Georgia
ZIP/Postal Code
30094
Country
United States
Facility Name
Pfizer Investigational Site
City
Honolulu
State/Province
Hawaii
ZIP/Postal Code
96814
Country
United States
Facility Name
Pfizer Investigational Site
City
Idaho Falls
State/Province
Idaho
ZIP/Postal Code
83404
Country
United States
Facility Name
Pfizer Investigational Site
City
Chicago
State/Province
Illinois
ZIP/Postal Code
60607
Country
United States
Facility Name
Pfizer Investigational Site
City
Chicago
State/Province
Illinois
ZIP/Postal Code
60654
Country
United States
Facility Name
Pfizer Investigational Site
City
Overland Park
State/Province
Kansas
ZIP/Postal Code
66212
Country
United States
Facility Name
Pfizer Investigational Site
City
Bethesda
State/Province
Maryland
ZIP/Postal Code
20817
Country
United States
Facility Name
Pfizer Investigational Site
City
Chaska
State/Province
Minnesota
ZIP/Postal Code
55318
Country
United States
Facility Name
Pfizer Investigational Site
City
Minneapolis
State/Province
Minnesota
ZIP/Postal Code
55455
Country
United States
Facility Name
Pfizer Investigational Site
City
Jackson
State/Province
Mississippi
ZIP/Postal Code
39202
Country
United States
Facility Name
Pfizer Investigational Site
City
Henderson
State/Province
Nevada
ZIP/Postal Code
89052
Country
United States
Facility Name
Pfizer Investigational Site
City
Las Vegas
State/Province
Nevada
ZIP/Postal Code
89101
Country
United States
Facility Name
Pfizer Investigational Site
City
Las Vegas
State/Province
Nevada
ZIP/Postal Code
89117
Country
United States
Facility Name
Pfizer Investigational Site
City
Fargo
State/Province
North Dakota
ZIP/Postal Code
58103
Country
United States
Facility Name
Pfizer Investigational Site
City
Cincinnati
State/Province
Ohio
ZIP/Postal Code
45249
Country
United States
Facility Name
Pfizer Investigational Site
City
Lansdale
State/Province
Pennsylvania
ZIP/Postal Code
19446
Country
United States
Facility Name
Pfizer Investigational Site
City
Rapid City
State/Province
South Dakota
ZIP/Postal Code
57702
Country
United States
Facility Name
Pfizer Investigational Site
City
Beaumont
State/Province
Texas
ZIP/Postal Code
77701
Country
United States
Facility Name
Pfizer Investigational Site
City
Beaumont
State/Province
Texas
ZIP/Postal Code
77706
Country
United States
Facility Name
Pfizer Investigational Site
City
Dallas
State/Province
Texas
ZIP/Postal Code
75231
Country
United States
Facility Name
Pfizer Investigational Site
City
Dallas
State/Province
Texas
ZIP/Postal Code
75246
Country
United States
Facility Name
Pfizer Investigational Site
City
Richmond
State/Province
Virginia
ZIP/Postal Code
23294
Country
United States
Facility Name
Pfizer Investigational Site
City
Pleven
ZIP/Postal Code
5800
Country
Bulgaria
Facility Name
Pfizer Investigational Site
City
Sofia
ZIP/Postal Code
1431
Country
Bulgaria
Facility Name
Pfizer Investigational Site
City
Sofia
ZIP/Postal Code
1606
Country
Bulgaria
Facility Name
Pfizer Investigational Site
City
Stara Zagora
ZIP/Postal Code
6000
Country
Bulgaria
Facility Name
Pfizer Investigational Site
City
Coquitlam
State/Province
British Columbia
ZIP/Postal Code
V3K 3P4
Country
Canada
Facility Name
Pfizer Investigational Site
City
Winnipeg
State/Province
Manitoba
ZIP/Postal Code
R3a 1R9
Country
Canada
Facility Name
Pfizer Investigational Site
City
Winnipeg
State/Province
Manitoba
ZIP/Postal Code
R3E 3P4
Country
Canada
Facility Name
Pfizer Investigational Site
City
London
State/Province
Ontario
ZIP/Postal Code
N6A 4V2
Country
Canada
Facility Name
Pfizer Investigational Site
City
Laval
State/Province
Quebec
ZIP/Postal Code
H7T 2P5
Country
Canada
Facility Name
Pfizer Investigational Site
City
Montreal
State/Province
Quebec
ZIP/Postal Code
H3A 1A1
Country
Canada
Facility Name
Pfizer Investigational Site
City
Bangalore
State/Province
Karnataka
ZIP/Postal Code
560 052
Country
India
Facility Name
Pfizer Investigational Site
City
Indore
State/Province
Madhya Pradesh
ZIP/Postal Code
452 001
Country
India
Facility Name
Pfizer Investigational Site
City
Nagpur
State/Province
Maharashtra
ZIP/Postal Code
440 012
Country
India
Facility Name
Pfizer Investigational Site
City
Nasik
State/Province
Maharashtra
ZIP/Postal Code
422 013
Country
India
Facility Name
Pfizer Investigational Site
City
Ladron de Guevara
State/Province
Guadalajara, Jalisco
ZIP/Postal Code
44656
Country
Mexico
Facility Name
Pfizer Investigational Site
City
Guadalajara
State/Province
Jalisco
ZIP/Postal Code
44340
Country
Mexico
Facility Name
Pfizer Investigational Site
City
Monterrey
State/Province
Nuevo Leon
ZIP/Postal Code
64460
Country
Mexico
Facility Name
Pfizer Investigational Site
City
Ponce
ZIP/Postal Code
00716
Country
Puerto Rico
Facility Name
Pfizer Investigational Site
City
San Juan
ZIP/Postal Code
00909
Country
Puerto Rico
Facility Name
Pfizer Investigational Site
City
Tao Baja
ZIP/Postal Code
00949
Country
Puerto Rico
Facility Name
Pfizer Investigational Site
City
Santiago de Compostela
State/Province
La Coruña
ZIP/Postal Code
15706
Country
Spain
Facility Name
Pfizer Investigational Site
City
Barcelona
ZIP/Postal Code
08036
Country
Spain
Facility Name
Pfizer Investigational Site
City
Madrid
ZIP/Postal Code
28040
Country
Spain
Facility Name
Pfizer Investigational Site
City
Sevilla
ZIP/Postal Code
41013
Country
Spain

12. IPD Sharing Statement

Links:
URL
https://trialinfoemail.pfizer.com/pages/landing.aspx?StudyID=A7211005&StudyName=A%20Trial%20In%20Diabetic%20Patients%20To%20Assess%20Effect%20Of%20CE-326%2C597%20On%20Glucose%20Control%20And%20Body%20Weight
Description
To obtain contact information for a study center near you, click here.

Learn more about this trial

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

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