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

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NCT00542009

Last updated on April 6, 2020
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Study Location
Pfizer Investigational Site
Phoenix, Arizona, 85023 United States
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Contact
1-800-718-1021
[email protected]
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Eligibility criteria
Condition
The disease, disorder, syndrome, illness, or injury that is being studied.
Weight Management, Treatment Of Obesity
Sex
Females and Males
Age
Pediatric Trials: 0-17 Years
Adult Trials: 18+ Years
18-65 years
Inclusion criteria
The factors, or reasons, that allow a person to participate in a clinical study.
Show details

Patients with type 2 diabetes, not on any or on oral (up to 2) anti-diabetic medications,
otherwise medically stable.

Exclusion criteria
The factors, or reasons, that prevent a person from participating in a clinical study.
Show details

Women of childbearing potential, people with unstable medical conditions, people with
gallstones

NCT00542009
Pfizer
Completed
A Trial In Diabetic Patients To Assess Effect Of CE-326,597 On Glucose Control And Body Weight

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Descriptive Information
Brief Title  ICMJE A Trial In Diabetic Patients To Assess Effect Of CE-326,597 On Glucose Control And Body Weight
Official Title  ICMJE 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
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
Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 2
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Treatment
Condition  ICMJE
  • Weight Management
  • Treatment Of Obesity
Intervention  ICMJE
  • Drug: CE-326,597 100 mg QD
    Administered orally, once daily with morning meal for duration of trial (84 days).
  • Drug: CE-326,597 50 mg QD
    Administered orally, once daily with morning meal for duration of trial (84 days).
  • Drug: CE-326,597 25 mg QD
    Administered orally, once daily with morning meal for duration of trial (84 days).
  • Drug: Placebo
    Placebo to match CE-326,597 tablets to be administered orally, once daily with morning meal for duration of trial (84 days).
  • Drug: CE-326,597 5mg QD
    Administered orally, once daily with morning meal for duration of trial (84 days).
Study Arms  ICMJE
  • Experimental: CE-326,597 100 mg QD
    Intervention: Drug: CE-326,597 100 mg QD
  • Experimental: CE-326,597 50 mg QD
    Intervention: Drug: CE-326,597 50 mg QD
  • Experimental: CE-326,597 25 mg QD
    Intervention: Drug: CE-326,597 25 mg QD
  • Placebo Comparator: Placebo
    Intervention: Drug: Placebo
  • Experimental: CE-326,597 5mg QD
    Intervention: Drug: CE-326,597 5mg QD
Publications * Not Provided


*   Includes publications given by the data provider as well as publications
identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: January 8, 2009) 		252
Original Enrollment  ICMJE
 (submitted: October 5, 2007) 		200
Actual Study Completion Date  ICMJE November 2008
Actual Primary Completion Date November 2008   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years to 65 Years   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Bulgaria,   Canada,   India,   Mexico,   Puerto Rico,   Spain,   United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT00542009
Other Study ID Numbers  ICMJE A7211005
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Pfizer
Study Sponsor  ICMJE Pfizer
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Study Director: Pfizer CT.gov Call Center Pfizer
PRS Account Pfizer
Verification Date November 2012

ICMJE     Data element required by the

International Committee of Medical Journal Editors and the
World Health Organization ICTRP

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