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Study Of Two Dosing Regimens Of PF-04937319 Compared To An Approved Agent (Sitagliptin) In Patients With Type 2 Diabetes

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NCT01933672

Last updated on October 4, 2018
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FOR MORE INFORMATION
Study Location
Avail Clinical Research, LLC
DeLand, Florida, 32720 United States
See other locations
Contact
1-800-718-1021
[email protected]
Related Links
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

- Patients with type 2 diabetes, on background metformin therapy either alone or with 1
other oral anti-diabetic agent (excluding Actos)

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

- Patients with cardiovascular event within 6-months of screening

- Patients with diabetic complications

- Female subjects who are pregnant or planning to become pregnant

- Subjects with unstable medical conditions (eg, hypertension)

NCT01933672
Pfizer
Completed
Study Of Two Dosing Regimens Of PF-04937319 Compared To An Approved Agent (Sitagliptin) In Patients With Type 2 Diabetes

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Study Of Two Dosing Regimens Of PF-04937319 Compared To An Approved Agent (Sitagliptin) In Patients With Type 2 Diabetes
A Phase 1b, Randomized, Double-blind, Active Comparator Controlled, 3-period, Cross-over Study To Characterize The Pharmacodynamics And Tolerability Of Two Dosing Regimens Of Pf-04937319 In Adults With Type 2 Diabetes Mellitus Inadequately Controlled On Metformin
Study B1621019 will assess efficacy and safety of two different dosing regimens of an investigational agent (PF-04937319) compared to an approved drug (sitagliptin) in patients with type 2 diabetes
Not Provided
Interventional
Phase 1
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Primary Purpose: Basic Science
Type 2 Diabetes Mellitus
  • Drug: PF-04937319 once-daily
    Tablets, 300 mg once-daily with breakfast, 14-days
  • Drug: PF-04937319 split-dose
    tablets, 150 mg with breakfast plus 100 mg with lunch, 14-days
  • Drug: Sitagliptin once-daily
    tablets, 100 mg once-daily with breakfast, 14-days
  • Experimental: PF-04937319 once-daily
    Intervention: Drug: PF-04937319 once-daily
  • Experimental: PF-04937319 split-dose
    Intervention: Drug: PF-04937319 split-dose
  • Active Comparator: Sitagliptin once-daily
    Intervention: Drug: Sitagliptin once-daily
Not Provided


*   Includes publications given by the data provider as well as publications
identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
33
March 2014
March 2014   (Final data collection date for primary outcome measure)

Inclusion Criteria:

  • Patients with type 2 diabetes, on background metformin therapy either alone or with 1 other oral anti-diabetic agent (excluding Actos)

Exclusion Criteria:

  • Patients with cardiovascular event within 6-months of screening
  • Patients with diabetic complications
  • Female subjects who are pregnant or planning to become pregnant
  • Subjects with unstable medical conditions (eg, hypertension)
Sexes Eligible for Study: All
18 Years to 70 Years   (Adult, Senior)
No
Contact information is only displayed when the study is recruiting subjects
United States
 
 
NCT01933672
B1621019
No
Not Provided
Not Provided
Pfizer
Pfizer
Not Provided
Study Director: Pfizer CT.gov Call Center Pfizer
Pfizer
August 2016

ICMJE     Data element required by the

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

FOR MORE INFORMATION

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