Study In Patients With Type 2 Diabetes Who Are Taking Metformin And Sulfonylurea, Metformin And Insulin, Or Insulin
This study has been completed.
Sponsor:
GlaxoSmithKline
Information provided by:
GlaxoSmithKline
ClinicalTrials.gov Identifier:
NCT00269061
First received: December 22, 2005
Last updated: October 15, 2008
Last verified: October 2008
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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
More Information
No publications provided
Keywords provided by GlaxoSmithKline:
Additional relevant MeSH terms:
ClinicalTrials.gov processed this record on October 16, 2012
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 Glucose Metabolism Disorders Metabolic Diseases Endocrine System Diseases |
Pioglitazone Hypoglycemic Agents Physiological Effects of Drugs Pharmacologic Actions |
ClinicalTrials.gov processed this record on October 16, 2012