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

NCT00542009

Last updated date
Study Location
Pfizer Investigational Site
Phoenix, Arizona, 85023, United States
Contact
1-800-718-1021

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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

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Weight Management, Treatment Of ObesityA Trial In Diabetic Patients To Assess Effect Of CE-326,597 On Glucose Control And Body Weight
NCT00542009
  1. Phoenix, Arizona
  2. Fresno, California
  3. National City, California
  4. San Diego, California
  5. Miami, Florida
  6. Ocala, Florida
  7. West Palm Beach, Florida
  8. Atlanta, Georgia
  9. Conyers, Georgia
  10. Honolulu, Hawaii
  11. Idaho Falls, Idaho
  12. Chicago, Illinois
  13. Chicago, Illinois
  14. Overland Park, Kansas
  15. Bethesda, Maryland
  16. Chaska, Minnesota
  17. Minneapolis, Minnesota
  18. Jackson, Mississippi
  19. Henderson, Nevada
  20. Las Vegas, Nevada
  21. Las Vegas, Nevada
  22. Fargo, North Dakota
  23. Cincinnati, Ohio
  24. Lansdale, Pennsylvania
  25. Rapid City, South Dakota
  26. Beaumont, Texas
  27. Beaumont, Texas
  28. Dallas, Texas
  29. Dallas, Texas
  30. Richmond, Virginia
  31. Pleven,
  32. Sofia,
  33. Sofia,
  34. Stara Zagora,
  35. Coquitlam, British Columbia
  36. Winnipeg, Manitoba
  37. Winnipeg, Manitoba
  38. London, Ontario
  39. Laval, Quebec
  40. Montreal, Quebec
  41. Bangalore, Karnataka
  42. Indore, Madhya Pradesh
  43. Nagpur, Maharashtra
  44. Nasik, Maharashtra
  45. Ladron de Guevara, Guadalajara, Jalisco
  46. Guadalajara, Jalisco
  47. Monterrey, Nuevo Leon
  48. Ponce,
  49. San Juan,
  50. Tao Baja,
  51. Santiago de Compostela, La Coruña
  52. Barcelona,
  53. Madrid,
  54. Sevilla,
ALL GENDERS
18 Years+
years
MULTIPLE SITES
Advanced Information
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 CenterPfizer
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