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

Non-Insulin-Dependent Diabetes Mellitus Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00269061
• Other study ID #: ADG104148
• Status: Completed
• Phase: Phase 1
• First received: December 22, 2005
• Last updated: October 15, 2008
• Start date: January 2006

Study information

• Verified date: October 2008
• Source: GlaxoSmithKline
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Food and Drug Administration
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 32
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 70 Years

Eligibility

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.

Study Design

Allocation: Randomized, Endpoint Classification: Pharmacodynamics Study, Intervention Model: Parallel Assignment, Masking: Double-Blind, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Diabetes Mellitus, Type 2
• Non-Insulin-Dependent Diabetes Mellitus

Intervention

Drug:
• pioglitazone

Locations

Country	Name	City	State
United States	GSK Investigational Site	Belmont	Massachusetts

Sponsors (1)

Lead Sponsor	Collaborator
GlaxoSmithKline

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Changes in interstitial fluid volume in the lower extremities as measured by MRI.
Secondary	Assessments of other indicators of fluid volume changes, including labwork evaluation, fluid compartment volume measurement, direct measurement of the calf.