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A Phase 1 Study In Japanese Subjects With Type 2 Diabetes Mellitus As Monotherapy

Last updated on December 16, 2017

FOR MORE INFORMATION
Study Location
P-one Clinic, Keikokai Medical Corporation
Hachioji-shi, Tokyo, 192-0071 Japan
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
20-64 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 diet/exercise therapy only or background therapy
with 1 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

- Patients with diabetic complications

- Female subjects who are pregnant or planning to become pregnant

- Subjects with unstable medical conditions (eg, hypertension)

NCT02292433
Pfizer
Completed
A Phase 1 Study In Japanese Subjects With Type 2 Diabetes Mellitus As Monotherapy

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A Phase 1 Study In Japanese Subjects With Type 2 Diabetes Mellitus As Monotherapy
A Phase 1, Randomized, Double-blind, Placebo-controlled, 3- Period, Crossover Study To Assess The Safety, Tolerability, Pharmacokinetics, And Pharmacodynamics Of Two Dose Levels of Pf-04937319 In Japanese Subjects With Type 2 Diabetes Mellitus as Monotherapy
Study B1621018 will assess the Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of Two Dose Levels of Pf-04937319 in Japanese Subjects with Type 2 Diabetes Mellitus As Monotherapy
Not Provided
Interventional
Phase 1
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Basic Science
Type 2 Diabetes Mellitus
  • Drug: PF-04937319 high dose
    tablets, 150 mg with breakfast plus 100 mg with lunch, 7 days
  • Drug: PF-04937319 low dose
    tablets, 50 mg with breakfast plus 50 mg with lunch, 7 days
  • Drug: Placebo
    tablets, breakfast plus lunch, 7 days
  • Experimental: PF-04937319
    PF-04937319 Split dose
    Interventions:
    • Drug: PF-04937319 high dose
    • Drug: PF-04937319 low dose
  • Placebo Comparator: Placebo
    Placebo split dose
    Intervention: Drug: Placebo
Not Provided


*   Includes publications given by the data provider as well as publications
identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
12
March 2015
March 2015   (Final data collection date for primary outcome measure)

Inclusion Criteria:

  • Patients with type 2 diabetes, on diet/exercise therapy only or background therapy with 1 oral anti-diabetic agent (excluding Actos)

Exclusion Criteria:

  • Patients with cardiovascular event
  • 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
20 Years to 64 Years   (Adult)
No
Contact information is only displayed when the study is recruiting subjects
Japan
 
 
NCT02292433
B1621018
No
Not Provided
Not Provided
Pfizer
Pfizer
Not Provided
Study Director: Pfizer CT.gov Call Center Pfizer
Pfizer
February 2016

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]



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