Efficacy, Safety and Tolerability of Pioglitazone-Azilsartan in Subjects With Type 2 Diabetes Mellitus

• Status: Terminated
• Trial end date: 2007-05-01
• Target enrollment: 0
• Participant gender: All

Summary

The purpose of this study is to evaluate the efficacy and safety of pioglitazone-azilsartan, once daily (QD), in subjects with type 2 diabetes mellitus with poor glycemic control.

• Phase: Phase 3
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Takeda
• Treatments: Azilsartan medoxomil; Pioglitazone

Criteria

Inclusion Criteria

• Type 2 diabetes with glycosylated hemoglobin of greater than or equal to 9.0 to less than or equal to 11.0% at Screening.

• Documented hypertension.

• On a stable diet and exercise program in addition to metformin alone or combination of metformin and a sulfonylurea for a minimum of 8 weeks prior to screening.

• If receiving antihypertensive therapy, must be on no more than 3 agents and be on a stable regimen.

• Clinical laboratory evaluations (including clinical chemistry, hematology, and urinalysis) within the reference range unless the results are deemed not clinically significant for inclusion into this study by the investigator.

• Females of childbearing potential who are sexually active must agree to use adequate contraception, and can neither be pregnant nor lactating from Screening throughout the duration of the study.

Exclusion Criteria

• Type 1 diabetes mellitus.

• Diastolic blood pressure greater than 104 mm Hg at randomization visit.

• Currently taking an angiotensin II-receptor blocker.

• Unstable angina or heart failure of any etiology with New York Heart Association functional class III or IV.

• History of myocardial infarction, cerebrovascular accident (stroke), percutaneous coronary intervention, coronary artery bypass graft or transient ischemic attack within the previous six months.

• Clinically significant cardiac conduction defects.

• Secondary hypertension of any etiology.

• Body mass index greater than 45 kg/m2

• Has significant renal dysfunction.

• History of drug abuse or a history of alcohol abuse within the past 2 years.

• Previous history of cancer, other than basal cell carcinoma or stage 1 squamous cell carcinoma of the skin that has not been in remission for at least 5 years prior to the first dose of study drug.

• Alanine transaminase or aspartate transaminase level of greater than 2.5 times the upper limit of normal, active liver disease, or jaundice.

• Serum potassium greater than the upper limit of normal.

• Currently participating in another investigational study or has participated in an investigational study within 30 days prior to Randomization.

• Any other serious disease or condition that would compromise subject safety, might affect life expectancy, or make it difficult to successfully manage and follow the subject according to the protocol.

• Is hypersensitive to angiotensin II receptor blockers.

• Is hypersensitive to thiazolidinediones.

• 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:

• any anti-diabetic agent (including thiazolidinediones and/or insulin) except for metformin or a combination of metformin and a sulfonylurea

• niacin more than 200mg per day

• tricyclic antidepressants or phenothiazines

• Angiotensin II receptor blockers

• Thiazolidinediones

• Insulin