Status:
COMPLETED
Study In Patients With Type 2 Diabetes Who Are Taking Metformin And Sulfonylurea, Metformin And Insulin, Or Insulin
Lead Sponsor:
GlaxoSmithKline
Conditions:
Non-Insulin-Dependent Diabetes Mellitus
Eligibility:
All Genders
18-70 years
Phase:
PHASE1
Brief Summary
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 diabe...
Eligibility Criteria
Inclusion
- 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.
Exclusion
Key Trial Info
Start Date :
January 1 2006
Trial Type :
INTERVENTIONAL
End Date :
Estimated Enrollment :
32 Patients enrolled
Trial Details
Trial ID
NCT00269061
Start Date
January 1 2006
Last Update
October 16 2008
Active Locations (1)
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1
GSK Investigational Site
Belmont, Massachusetts, United States, 02478