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

NCT ID: NCT02292433

Last Updated: 2016-03-15

Study Results

Results available

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE1

Total Enrollment

12 participants

Study Classification

INTERVENTIONAL

Study Start Date

2015-01-31

Study Completion Date

2015-03-31

Brief Summary

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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

Detailed Description

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Conditions

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Type 2 Diabetes Mellitus

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

CROSSOVER

Primary Study Purpose

BASIC_SCIENCE

Blinding Strategy

DOUBLE

Participants Investigators

Study Groups

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PF-04937319

PF-04937319 Split dose

Group Type EXPERIMENTAL

PF-04937319 high dose

Intervention Type DRUG

tablets, 150 mg with breakfast plus 100 mg with lunch, 7 days

PF-04937319 low dose

Intervention Type DRUG

tablets, 50 mg with breakfast plus 50 mg with lunch, 7 days

Placebo

Placebo split dose

Group Type PLACEBO_COMPARATOR

Placebo

Intervention Type DRUG

tablets, breakfast plus lunch, 7 days

Interventions

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PF-04937319 high dose

tablets, 150 mg with breakfast plus 100 mg with lunch, 7 days

Intervention Type DRUG

PF-04937319 low dose

tablets, 50 mg with breakfast plus 50 mg with lunch, 7 days

Intervention Type DRUG

Placebo

tablets, breakfast plus lunch, 7 days

Intervention Type DRUG

Eligibility Criteria

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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)
Minimum Eligible Age

20 Years

Maximum Eligible Age

64 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Pfizer

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Pfizer CT.gov Call Center

Role: STUDY_DIRECTOR

Pfizer

Locations

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P-one Clinic, Keikokai Medical Corporation

Hachioji-shi, Tokyo, Japan

Site Status

Countries

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Japan

Related Links

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Other Identifiers

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B1621018

Identifier Type: -

Identifier Source: org_study_id

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