You are here

Study Of Safety And Efficacy Of PF-04991532 In Subjects With Type 2 Diabetes Mellitus

Last updated on May 10, 2018

FOR MORE INFORMATION
Study Location
Pfizer Investigational Site
Jonesboro, Arkansas, 72401 United States
Contact
1-800-718-1021
Eligibility criteria
Condition
The disease, disorder, syndrome, illness, or injury that is being studied.
Type 2 Diabetes
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.

NCT01336738
Pfizer
Completed
Study Of Safety And Efficacy Of PF-04991532 In Subjects With Type 2 Diabetes Mellitus

NEED INFO?

Questions about a trial? Call or email to reach a Pfizer Clinical Trial Contact Center

Pfizer Clinical Trials Contact Center

1-800-718-1021

[email protected]

call now

Try a new search

Search for Clinical Trials by condition, keyword or trial number. Share your location or enter your zip code, city, or country to find studies near you.

Similar Trials

Part 1, MELANOMA, SCCHN, OVCA, SARCOMA, OTHER SOLID TUMORS, Part 1 and 2, NSCLC, UROTHELIAL CARCINOMA
NCT02573259
All Genders
18+
Years
Multiple Sites
Ovarian Cancer HR+ HER2- Metastatic Breast Cancer
NCT03519178
All Genders
18+
Years
Multiple Sites
Type 2 Diabetes Mellitus
NCT01856595
All Genders
18+
Years
Multiple Sites
Diabetes Mellitus
NCT00134147
All Genders
35+
Years
Multiple Sites
Study Of Safety And Efficacy Of PF-04991532 In Subjects With Type 2 Diabetes Mellitus
A 12-Week, Phase 2, Randomized, Double-Blind, Placebo Controlled, Dose-Ranging, Parallel Group Study To Evaluate The Efficacy And Safety Of Once Daily Pf-04991532 And Sitagliptin In Adult Patients With Type 2 Diabetes Mellitus Inadequately Controlled On Metformin
B2611002 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 5 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, Type 2
  • Drug: Placebo
    Tablets (n=6), 0 mg, once daily for 84 days
  • Drug: 150 mg PF-04991532
    Tablets (n=1), 150 mg + tablets (n=5), 0 mg, all once daily for 84 days
  • Drug: 450 mg PF-04991532
    Tablets (n=3), 150 mg + tablets (n=3), 0 mg, all once daily for 84 days
  • Drug: 750 mg PF-04991532
    Tablets (n=5), 150 mg + tablets (n=1), 0 mg, all once daily for 84 days
  • Drug: Sitagliptin 100 mg
    Tablets (n=1), 100 mg strength + tablets (n=5), 0 mg, all once daily for 84 days
  • Placebo Comparator: Placebo
    Matching placebo for PF-04991532 and Sitagliptin
    Intervention: Drug: Placebo
  • Experimental: 150 mg PF-04991532
    Intervention: Drug: 150 mg PF-04991532
  • Experimental: 450 mg PF-04991532
    Intervention: Drug: 450 mg PF-04991532
  • Experimental: 750 mg PF-04991532
    Intervention: Drug: 750 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
266
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,   Korea, Republic of,   Mexico,   Slovakia,   Taiwan,   United States
 
 
NCT01336738
B2611002
Yes
Not Provided
Not Provided
Pfizer
Pfizer
Not Provided
Study Director: Pfizer CT.gov Call Center Pfizer
Pfizer
June 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.

BY PHONE

Pfizer Clinical Trials Contact Center

1-800-718-1021

BY EMAIL

Contact

[email protected]



Call Now