Study In Patients With Type 2 Diabetes Who Are Taking Metformin And Sulfonylurea, Metformin And Insulin, Or Insulin

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

COMPLETED

Clinical Phase

PHASE1

Total Enrollment

32 participants

Study Classification

INTERVENTIONAL

Study Start Date

2006-01-31

Brief Summary

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This study will use Magnetic Resonance Imaging (MRI) techniques to evaluate changes in fluid volume in the lower legs of diabetic patients who add either pioglitazone or placebo to their current diabetic regimen.

Detailed Description

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Conditions

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Non-Insulin-Dependent Diabetes Mellitus

Keywords

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pioglitazone diabetes fluid

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

DOUBLE

Interventions

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pioglitazone

Intervention Type DRUG

Eligibility Criteria

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Inclusion Criteria

* Must have been diagnosed with Type 2 diabetes at least three months prior to screening.
* Must be taking either metformin and a sulfonylurea, metformin and insulin, or insulin only, and doses of these medications must have been stable for at least three months.
* Must have a Body Mass Index (BMI) of between 24 and 35.
* If female, the subject must be post-menopausal.
* HbA1c levels must be between 7% and 10%.
* Subjects must be eligible for MRI scanning (ie, no metal implants, pacemaker, etc).

Exclusion Criteria

* Suffer from claustrophobia.
* Use of tobacco, nicotine, or illegal drugs of abuse.
* Use of caffeine within two days prior to each study visit.
* HIV, hepatitis, edema, untreated blood pressure problems, heart, lung, nervous system or kidney disease, history of blood clots in the legs, diabetic neuropathy, or untreated thyroid disease.
* Use of drugs or medications that affect the levels of fluid in the body, such as diuretics.

Minimum Eligible Age

18 Years

Maximum Eligible Age

70 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Responsible Party

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GSK

Principal Investigators

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GSK Clinical Trials, MD

Role: STUDY_DIRECTOR

GlaxoSmithKline

Locations

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GSK Investigational Site

Belmont, Massachusetts, United States

Site Status

Countries

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United States

Other Identifiers

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ADG104148

Identifier Type: -

Identifier Source: org_study_id