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

This study has been completed.
Sponsor:
Information provided by:
GlaxoSmithKline
ClinicalTrials.gov Identifier:
NCT00269061
First received: December 22, 2005
Last updated: October 15, 2008
Last verified: October 2008
  Purpose

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 Intervention Phase
Non-Insulin-Dependent Diabetes Mellitus
Drug: pioglitazone
Phase 1

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Pharmacodynamics Study
Intervention Model: Parallel Assignment
Masking: Double-Blind
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

Resource links provided by NLM:


Further study details as provided by GlaxoSmithKline:

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: 32
Study Start Date: January 2006
Intervention Details:
    Drug: pioglitazone
    Other Name: pioglitazone
  Eligibility

Ages Eligible for Study:   18 Years to 70 Years
Genders Eligible for Study:   Both
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.
  Contacts and Locations
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

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

No publications provided

Responsible Party: Study Director, GSK
ClinicalTrials.gov Identifier: NCT00269061     History of Changes
Other Study ID Numbers: ADG104148
Study First Received: December 22, 2005
Last Updated: October 15, 2008
Health Authority: United States: Food and Drug Administration

Keywords provided by GlaxoSmithKline:
pioglitazone
diabetes
fluid

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

ClinicalTrials.gov processed this record on October 20, 2014