Last updated: 11/04/2018 04:33:18
Study In Patients With Type 2 Diabetes Who Are Taking Metformin And Sulfonylurea, Metformin And Insulin, Or Insulin
GSK study ID
ADG104148
Clinicaltrials.gov ID
EudraCT ID
Not applicable
EU CT Number
Not applicable
Trial status
Completed
Completed
Trial overview
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
Trial description: 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.
Primary purpose:
Treatment
Trial design:
Parallel Assignment
Masking:
Not applicable
Allocation:
Randomized
Primary outcomes:
Not applicable
Secondary outcomes:
Not applicable
Interventions:
Drug: pioglitazone
Enrollment:
32
Observational study model:
Not applicable
Primary completion date:
Not applicable
Time perspective:
Not applicable
Clinical publications:
Not applicable
Medical condition
Non-Insulin-Dependent Diabetes Mellitus
Product
Not applicable
Collaborators
Not applicable
Study date(s)
January 2006 to September 2007
Type
Interventional
Phase
1
Participation criteria
Sex
Female & Male
Age
18 - 70 Years
Accepts healthy volunteers
no
- 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.
- Suffer from claustrophobia.
- Use of tobacco, nicotine, or illegal drugs of abuse.
Inclusion and exclusion 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.
Trial location(s)
Location
GSK Investigational Site
Belmont, Massachusetts, United States, 02478
Status
Study Complete
Study documents
No study documents available.
Results overview
Study Results yet to be posted
Recruitment status
Completed
Actual primary completion date
Not applicable
Actual study completion date
2007-07-09
Plain language summaries
Plain language summaries of clinical trial results for Phase 2-4 clinical trials that were initiated on or after January 2022 will be posted by GSK within one year following study completion.
Additional information about the trial
Additional information
Not applicable
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