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

Last updated on May 11, 2018

FOR MORE INFORMATION
Study Location
Pfizer Investigational Site
Phoenix, Arizona, 85023 United States
Contact
1-800-718-1021
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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A Trial In Diabetic Patients To Assess Effect Of CE-326,597 On Glucose Control And Body Weight
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
Not Provided
Interventional
Phase 2
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Treatment
  • Weight Management
  • Treatment Of Obesity
  • 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).
  • 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
Not Provided


*   Includes publications given by the data provider as well as publications
identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
252
November 2008
November 2008   (Final data collection date for primary outcome measure)

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

Sexes Eligible for Study: All
18 Years to 65 Years   (Adult)
No
Contact information is only displayed when the study is recruiting subjects
Bulgaria,   Canada,   India,   Mexico,   Puerto Rico,   Spain,   United States
 
 
NCT00542009
A7211005
No
Not Provided
Not Provided
Pfizer
Pfizer
Not Provided
Study Director: Pfizer CT.gov Call Center Pfizer
Pfizer
November 2012

ICMJE     Data element required by the

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

FOR MORE INFORMATION

Contact a representative by phone, email, or visiting thte study website. To get updates and notications about this trail, sign up using the form below.

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1-800-718-1021

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[email protected]



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