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

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ClinicalTrials.gov Identifier: NCT00269061
Recruitment Status : Completed
First Posted : December 23, 2005
Last Update Posted : October 16, 2008
Sponsor:
Information provided by:
GlaxoSmithKline

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 diabetic regimen.

Condition or disease Intervention/treatment Phase
Non-Insulin-Dependent Diabetes Mellitus Drug: pioglitazone Phase 1

Study Type : Interventional  (Clinical Trial)
Enrollment : 32 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double
Primary Purpose: Treatment
Official Title: 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
Study Start Date : January 2006

Resource links provided by the National Library of Medicine

U.S. FDA Resources




Primary Outcome Measures :
  1. Changes in interstitial fluid volume in the lower extremities as measured by MRI.

Secondary Outcome Measures :
  1. Assessments of other indicators of fluid volume changes, including labwork evaluation, fluid compartment volume measurement, direct measurement of the calf.


Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 70 Years   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00269061


Locations
United States, Massachusetts
GSK Investigational Site
Belmont, Massachusetts, United States, 02478
Sponsors and Collaborators
GlaxoSmithKline
Investigators
Study Director: GSK Clinical Trials, MD GlaxoSmithKline

Responsible Party: Study Director, GSK
ClinicalTrials.gov Identifier: NCT00269061     History of Changes
Other Study ID Numbers: ADG104148
First Posted: December 23, 2005    Key Record Dates
Last Update Posted: October 16, 2008
Last Verified: October 2008

Keywords provided by GlaxoSmithKline:
pioglitazone
diabetes
fluid

Additional relevant MeSH terms:
Diabetes Mellitus
Diabetes Mellitus, Type 2
Glucose Metabolism Disorders
Metabolic Diseases
Endocrine System Diseases
Pioglitazone
Hypoglycemic Agents
Physiological Effects of Drugs