Study of Safety and Efficacy of PF-04991532 in Subjects With Type 2 Diabetes

NCT01338870

Last updated date
Study Location
Pfizer Investigational Site
Little Rock, Arkansas, 72205, 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.
Type 2 Diabetes Mellitus
Sex
Females and Males
Age
Pediatric Trials: 0-17 Years
Adult Trials: 18+ Years
18-70 years
Inclusion Criteria
The factors, or reasons, that allow a person to participate in a clinical study.
Show details

Subjects with type 2 diabetes on stable doses of background medicines for management of diabetes; aged 18-70 years; body mass index between 22.5 and 45.5 kg/m2

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


Subjects with type 1 diabetes, heart attack or stroke in the past 6 months, uncontrolled
blood pressure, significant kidney disease.

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Advanced Information
Descriptive Information
Brief Title  ICMJE Study of Safety and Efficacy of PF-04991532 in Subjects With Type 2 Diabetes
Official Title  ICMJE A 12-week, Phase 2, Randomized, Double-blind, Placebo Controlled, Dose-ranging, Parallel Group Study to Evaluate the Efficacy and Safety of Twice Daily Pf-04991532 and Once Daily Sitagliptin in Adult Patients With Type 2 Diabetes Mellitus Inadequately Controlled on Metformin
Brief Summary B2611003 is designed to study how safe and effective an investigational medication (PF-04991532) is in people with Type 2 diabetes. Subjects in the study will receive 1 of 6 treatments for 3 months. One of the treatments will be sitagliptin which is an approved drug, and another treatment will be placebo, which does not contain active ingredient.
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 Diabetes Mellitus, Type 2
Intervention  ICMJE
  • Drug: Placebo
    Tablets (n=4), 0 mg twice daily for 84 days
  • Drug: 25 mg PF-04991532
    Tablets (n=1), 25 mg strength + tablets (n=3) 0 mg twice daily for 84 days
  • Drug: 75 mg PF-04991532
    Tablets (n=3), 25 mg strength + tablets (n=1) 0 mg twice daily for 84 days
  • Drug: 150 mg PF-04991532
    Tablets (n=1), 150 mg strength + tablets (n=3) 0 mg twice daily for 84 days
  • Drug: 300 mg PF-04991532
    Tablets (n=2), 150 mg strength + tablets (n=2) 0 mg twice daily for 84 days
  • Drug: Sitagliptin 100 mg
    Tablets (n=1), 100 mg strength + tablets (n=3) 0 mg once daily in the morning for 84 days; and tablets (n=4) 0 mg once daily in the evening for 84 days.
Study Arms  ICMJE
  • Placebo Comparator: Placebo
    Placebo for PF-04991532 and sitagliptin
    Intervention: Drug: Placebo
  • Experimental: 25 mg PF-04991532
    Intervention: Drug: 25 mg PF-04991532
  • Experimental: 75 mg PF-04991532
    Intervention: Drug: 75 mg PF-04991532
  • Experimental: 150 mg PF-04991532
    Intervention: Drug: 150 mg PF-04991532
  • Experimental: 300 mg PF-04991532
    Intervention: Drug: 300 mg PF-04991532
  • Active Comparator: Sitagliptin 100 mg
    Intervention: Drug: Sitagliptin 100 mg
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: February 27, 2013)
301
Original Estimated Enrollment  ICMJE
 (submitted: April 18, 2011)
288
Actual Study Completion Date  ICMJE March 2012
Actual Primary Completion Date March 2012   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion Criteria:

Subjects with type 2 diabetes on stable doses of background medicines for management of diabetes; aged 18-70 years; body mass index between 22.5 and 45.5 kg/m2

Exclusion Criteria:

Subjects with type 1 diabetes, heart attack or stroke in the past 6 months, uncontrolled blood pressure, significant kidney disease.

Sex/Gender  ICMJE
Sexes Eligible for Study:All
Ages  ICMJE 18 Years to 70 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 Canada,   Hungary,   Mexico,   Slovakia,   Taiwan,   United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT01338870
Other Study ID Numbers  ICMJE B2611003
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 March 2013

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP