A 6-Week Study To Determine The Safety And Effect Of An Investigational Drug On Adults With Type 2 Diabetes Mellitus Taking Metformin

NCT ID: NCT02053103

Last Updated: 2016-05-02

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

TERMINATED

Clinical Phase

PHASE2

Total Enrollment

13 participants

Study Classification

INTERVENTIONAL

Study Start Date

2014-03-31

Study Completion Date

2014-04-30

Brief Summary

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A Phase 2a study to evaluate the effects of an investigational compound administered at 200 mg, twice daily (BID), for 6 weeks in adult subjects with Type 2 Diabetes Mellitus (T2DM) on metformin background therapy.

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

PARALLEL

Primary Study Purpose

BASIC_SCIENCE

Blinding Strategy

DOUBLE

Participants Investigators

Study Groups

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PF-05175157

Group Type EXPERIMENTAL

PF-05175157

Intervention Type DRUG

Tablet, 200 mg, twice daily, 6 weeks

Placebo

Group Type PLACEBO_COMPARATOR

Placebo

Intervention Type DRUG

Tablet, 0 mg, twice daily, 6 weeks

Interventions

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PF-05175157

Tablet, 200 mg, twice daily, 6 weeks

Intervention Type DRUG

Placebo

Tablet, 0 mg, twice daily, 6 weeks

Intervention Type DRUG

Eligibility Criteria

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Inclusion Criteria

* Patients with Type 2 Diabetes Mellitus and treated with metformin at a dose greater than or equal to 1000 mg for at least 3 months
* Hemoglobin A1c of 7-10% at screening.
* Body Mass Index of at least 25 kg/m2.

Exclusion Criteria

* Compliant with study drug administration during the run-in period and throughout the trial.
* Patients with fasting triglycerides greater than 500 mg/dL at screening.
* History of certain diabetic complications or cardiac problems.
Minimum Eligible Age

18 Years

Maximum Eligible Age

65 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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Pfizer Investigational Site

Orlando, Florida, United States

Site Status

Countries

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United States

Related Links

Other Identifiers

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B1731002

Identifier Type: -

Identifier Source: org_study_id

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