Study In Patients With Type 2 Diabetes Who Are Taking Metformin And Sulfonylurea, Metformin And Insulin, Or Insulin
This study has been completed.
Information provided by:
First received: December 22, 2005
Last updated: October 15, 2008
Last verified: October 2008
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.
Non-Insulin-Dependent Diabetes Mellitus
Endpoint Classification: Pharmacodynamics Study
Intervention Model: Parallel Assignment
Primary Purpose: Treatment
||An Exploratory MRI Study in Type 2 Diabetic Subjects: A Randomized, Double-Blinded, Placebo-Controlled Trial to Evaluate the Measurement of Fluid Volumes by MRI in the Lower Extremities of Subjects Receiving Pioglitazone
Primary Outcome Measures:
- Changes in interstitial fluid volume in the lower extremities as measured by MRI.
Secondary Outcome Measures:
- Assessments of other indicators of fluid volume changes, including labwork evaluation, fluid compartment volume measurement, direct measurement of the calf.
| Estimated Enrollment:
| Study Start Date:
Other Name: pioglitazone
|Ages Eligible for Study:
||18 Years to 70 Years
|Genders Eligible for Study:
|Accepts Healthy Volunteers:
- 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).
- 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.
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study.
To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below.
For general information, see Learn About Clinical Studies.
Please refer to this study by its ClinicalTrials.gov identifier: NCT00269061
|GSK Investigational Site
|Belmont, Massachusetts, United States, 02478 |
||GSK Clinical Trials, MD
No publications provided
||Study Director, GSK
History of Changes
|Other Study ID Numbers:
|Study First Received:
||December 22, 2005
||October 15, 2008
||United States: Food and Drug Administration
Keywords provided by GlaxoSmithKline:
Additional relevant MeSH terms:
ClinicalTrials.gov processed this record on March 25, 2015
Diabetes Mellitus, Type 2
Endocrine System Diseases
Glucose Metabolism Disorders
Physiological Effects of Drugs