Status:
COMPLETED
Efficacy and Safety of Pioglitazone in Treating Subjects With Vascular Complications Associated With Type 2 Diabetes Mellitus.
Lead Sponsor:
Takeda
Conditions:
Diabetes Mellitus
Eligibility:
All Genders
40-70 years
Phase:
PHASE4
Brief Summary
The purpose of this study is to determine the efficacy of pioglitazone compared to glibenclamide, once daily (QD), taken together with metformin and lifestyle modification in type 2 diabetic subjects ...
Detailed Description
Diabetes is one of the most common chronic diseases worldwide, affecting nearly 200 million people, almost all suffering from Type 2 Diabetes. It is the fourth leading cause of death in developed coun...
Eligibility Criteria
Inclusion
- Females must be non-pregnant, non-lactating and post-menopausal.
- A glycosylated hemoglobin level greater than 7.5% and less than 10%.
- Has an age of onset of Type 2 Diabetes greater than 35 years of age.
- Is on metformin monotherapy up to the maximum tolerated daily dose.
- Has a normal or only slightly impaired renal function (a modification of diet in renal disease estimated glomerular filtration rate greater than 60 ml/min/1.73m2.
- Antihypertensives, statins and any other hypolipidemic medications have been initiated at least three months prior to enrollment; no dose modifications are allowed during the study.
- Has one or more cardiovascular comorbidities as follows:
- stable angina pectoris
- previous (greater than three months) transient ischemic attack, cerebrovascular accident or carotid atherosclerosis as assessed by bilateral carotid artery ultrasonography
- peripheral vascular complications documented by a history of claudication or rest pain, ultrasonography or angiography.
- and/or two or more of the following major cardiovascular risk factors:
- hypertension (blood pressure \>130/80 mmHg or treatment)
- dyslipidemia (low-density lipoprotein-cholesterol \>100 mg/dl or treatment and/or high-density lipoprotein-cholesterol \<40 mg/dl in men and \<45 mg/dl in women or treatment)
- smoking (\>10 cigarettes/day)
Exclusion
- Has Type 1 Diabetes.
- Is on insulin therapy.
- Is severely obese defined as a body mass index greater than or equal to 40mg/m2
- Has diabetic retinopathy.
- Has evidence of hepatic dysfunction including liver transaminase greater than three times the upper limit of normal.
- Is unable to remain on a stable dose of the following class of medications 30 days prior to randomization and throughout the six months of the study:
- antihypertensives
- statins
- other hypolipidemic and antiplatelet drugs
- Has a history of alcohol or other drug abuse.
- Has had a new diagnosis of cancer or recurrent cancer within five years of screening.
- Has a need for chronic (greater than two weeks) immunosuppressive therapy.
- Has had heart failure based on the New York Heart Association Functional Class I through IV.
- Is required to take or intends to continue taking any disallowed medication, any prescription medication, herbal treatment or over-the counter medication that may interfere with evaluation of the study medication, including:
- Other antidiabetic drugs (except metformin)
- Fibrates
- Rifampicin
- Glibenclamide interacting drugs, including nonsteroidal anti-inflammatory agents
- Other drugs that are highly protein bound, including:
- sulphonamides
- chloramphenicol
- probenecid
- monoamine oxidase inhibitors
- fluoroquinolones antibiotics
- oral miconazole
- Has participated in another clinical study within the past three months.
Key Trial Info
Start Date :
March 1 2009
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
May 1 2011
Estimated Enrollment :
39 Patients enrolled
Trial Details
Trial ID
NCT00770835
Start Date
March 1 2009
End Date
May 1 2011
Last Update
July 12 2011
Active Locations (2)
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1
Padua, Italy
2
Pisa, Italy