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

Completed · Phase 1

Conditions studied: Non-Insulin-Dependent Diabetes Mellitus

In brief

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.

Key facts

Study ID

NCT00269061

Run by

GlaxoSmithKline

People needed

32

Starts

2006-01-01

Last updated by the study team

2008-10-16

Who can join

Age: 18 and older, up to 70. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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).

You may not qualify if…

• 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.

Where it is running

• GSK Investigational Site — Belmont, Massachusetts, United States

Full record on ClinicalTrials.gov

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