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A 2-week Trial Of PF-04991532 In Patients With Type 2 Diabetes

NCT ID: NCT01469065

Last Updated: 2013-10-30

Study Results

Results available

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE1

Total Enrollment

82 participants

Study Classification

INTERVENTIONAL

Study Start Date

2011-12-31

Study Completion Date

2012-05-31

Brief Summary

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This will be a 2-week oral dose study of PF 04991532, performed in patients with type 2 diabetes. Safety, pharmacokinetics (how the drug is distributed in the body), and pharmacodynamics (how the drug works in the body) will be studied. Patients may be asked to wash off their diabetes medication for 4-6 prior to study drug administration, and they will remain in the clinical research unit for a total of 20 days for baseline tests, 2 weeks of dosing, and some follow up tests.

Detailed Description

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Conditions

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Diabetes Mellitus, Type 2

Keywords

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inpatient diabetes phase 1

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-04991532

PF-04991532 experimental study medication

Group Type EXPERIMENTAL

PF-04991532

Intervention Type DRUG

Oral administration of PF-04991532; 25 mg given twice a day (BID) for 14 days

PF-04991532

Intervention Type DRUG

Oral administration of PF-04991532; 75 mg given twice a day (BID) for 14 days

PF-04991532

Intervention Type DRUG

Oral administration of PF-04991532; 150 mg given twice a day (BID) for 14 days

PF-0499132

Intervention Type DRUG

Oral administration of PF-04991532; 300 mg given twice a day (BID) for 14 days

Placebo

PF-04991532 Matching Placebo

Group Type PLACEBO_COMPARATOR

Placebo

Intervention Type DRUG

Oral administration of PF-04991532 Matching Placebo; given twice a day (BID) for 14 days

Interventions

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PF-04991532

Oral administration of PF-04991532; 25 mg given twice a day (BID) for 14 days

Intervention Type DRUG

PF-04991532

Oral administration of PF-04991532; 75 mg given twice a day (BID) for 14 days

Intervention Type DRUG

PF-04991532

Oral administration of PF-04991532; 150 mg given twice a day (BID) for 14 days

Intervention Type DRUG

PF-0499132

Oral administration of PF-04991532; 300 mg given twice a day (BID) for 14 days

Intervention Type DRUG

Placebo

Oral administration of PF-04991532 Matching Placebo; given twice a day (BID) for 14 days

Intervention Type DRUG

Eligibility Criteria

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Inclusion Criteria

* Patients with type 2 diabetes mellitus who are taking either no medication for the treatment of diabetes (diet/exercise therapy only), or who are taking only a single oral anti-diabetic drug (OAD) that can be temporarily discontinued for approximately 8-10 weeks. For those taking a single OAD, treatment should be stable, where this is defined as no change in the treatment, including dose, over the past 3 months prior to Screening. OAD medications that are acceptable to be discontinued include: a sulfonylurea (SU), a meglitinide, a biguanide (eg, metformin), a dipeptidyl peptidase 4 inhibitor (DPP-4i), or an alpha glucosidase inhibitor.
* Body Mass Index (BMI) of 18.5 to 45.0 kg/m2; and a total body weight \>50 kg (110 lbs).
* HbA1c \>/=7% and \</=10% if the patient is on diet/exercise therapy only and does not require any OAD discontinuation. HbA1c \>/=6.5% and \</=9% if the patient requires to be washed off an OAD.

Exclusion Criteria

* Evidence or history of diabetic complications with significant end organ damage.
* History of stroke or transient ischemic attack.
* History of myocardial infarction.
* History of coronary artery bypass graft or stent implantation.
* Clinically significant peripheral vascular disease.
* Any history or clinical evidence of congestive heart failure, NYHA Classes II IV.
* Current history of angina/unstable angina.
* One or more episodes of hypoglycemia within the last 3 months, or two or more episodes of hypoglycemia within the last 6 months.
* A positive urine drug screen.
* Use of tobacco or nicotine-containing products in excess of the equivalent of 10 cigarettes per day.
* Blood pressure \>/=160 mm Hg (systolic) or \>/=100 mm Hg (diastolic), following at least 5 minutes of rest.
* Pregnant or nursing females; females of childbearing potential.
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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Pfizer Investigational Site

Chula Vista, California, United States

Site Status

Pfizer Investigational Site

Miami, Florida, United States

Site Status

Pfizer Investigational Site

Hachioji-shi, Tokyo, Japan

Site Status

Countries

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United States Japan

Related Links

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https://trialinfoemail.pfizer.com/pages/landing.aspx?StudyID=B2611005&StudyName=A%202-week%20Trial%20Of%20PF-04991532%20In%20Patients%20With%20Type%202%20Diabetes

To obtain contact information for a study center near you, click here.

Other Identifiers

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B2611005

Identifier Type: -

Identifier Source: org_study_id