Efficacy and Safety of Pioglitazone in Treating Subjects With Vascular Complications Associated With Type 2 Diabetes Mellitus.

• Status: Completed
• Trial end date: 2011-05-01
• Target enrollment: 0
• Participant gender: All

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 with cardiovascular disease.

• Phase: Phase 4
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Takeda
• Treatments: Glyburide; Metformin; Pioglitazone

Criteria

Inclusion Criteria:

• 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 Criteria:

• 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.