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

NCT ID: NCT01933672

Last Updated: 2016-09-27

Study Results

Results available

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE1

Total Enrollment

33 participants

Study Classification

INTERVENTIONAL

Study Start Date

2013-10-31

Study Completion Date

2014-03-31

Brief Summary

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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

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

TRIPLE

Participants Caregivers Investigators

Study Groups

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PF-04937319 once-daily

Group Type EXPERIMENTAL

PF-04937319 once-daily

Intervention Type DRUG

Tablets, 300 mg once-daily with breakfast, 14-days

PF-04937319 split-dose

Group Type EXPERIMENTAL

PF-04937319 split-dose

Intervention Type DRUG

tablets, 150 mg with breakfast plus 100 mg with lunch, 14-days

Sitagliptin once-daily

Group Type ACTIVE_COMPARATOR

Sitagliptin once-daily

Intervention Type DRUG

tablets, 100 mg once-daily with breakfast, 14-days

Interventions

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PF-04937319 once-daily

Tablets, 300 mg once-daily with breakfast, 14-days

Intervention Type DRUG

PF-04937319 split-dose

tablets, 150 mg with breakfast plus 100 mg with lunch, 14-days

Intervention Type DRUG

Sitagliptin once-daily

tablets, 100 mg once-daily with breakfast, 14-days

Intervention Type DRUG

Eligibility Criteria

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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)
Minimum Eligible Age

18 Years

Maximum Eligible Age

70 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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Avail Clinical Research, LLC

DeLand, Florida, United States

Site Status

Miami Research Associates, Inc.

South Miami, Florida, United States

Site Status

MRA Clinical Research, LLC

South Miami, Florida, United States

Site Status

High Point Clinical Trials Center, LLC

High Point, North Carolina, United States

Site Status

Community Research

Cincinnati, Ohio, United States

Site Status

Clinical Trials of Texas, Inc

San Antonio, Texas, United States

Site Status

Diabetes and Glandular Disease Clinic

San Antonio, Texas, United States

Site Status

Spaulding Clinical Research, LLC

West Bend, Wisconsin, United States

Site Status

Countries

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United States

Related Links

Other Identifiers

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B1621019

Identifier Type: -

Identifier Source: org_study_id

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