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

Last updated on December 17, 2017

FOR MORE INFORMATION
Study Location
Pfizer Investigational Site
Little Rock, Arkansas, 72205 United States
Contact
1-800-718-1021
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.

NCT01338870
Pfizer
Completed
Study of Safety and Efficacy of PF-04991532 in Subjects With Type 2 Diabetes

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Study of Safety and Efficacy of PF-04991532 in Subjects With Type 2 Diabetes
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
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.
Not Provided
Interventional
Phase 2
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Treatment
Diabetes Mellitus, Type 2
  • 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.
  • 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
Not Provided


*   Includes publications given by the data provider as well as publications
identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
301
March 2012
March 2012   (Final data collection date for primary outcome measure)

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.

Sexes Eligible for Study: All
18 Years to 70 Years   (Adult, Senior)
No
Contact information is only displayed when the study is recruiting subjects
Canada,   Hungary,   Mexico,   Slovakia,   Taiwan,   United States
 
 
NCT01338870
B2611003
No
Not Provided
Not Provided
Pfizer
Pfizer
Not Provided
Study Director: Pfizer CT.gov Call Center Pfizer
Pfizer
March 2013

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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