Status:
TERMINATED
Efficacy, Safety and Tolerability of Pioglitazone-Azilsartan in Subjects With Type 2 Diabetes Mellitus
Lead Sponsor:
Takeda
Conditions:
Type 2 Diabetes
Eligibility:
All Genders
18+ years
Phase:
PHASE3
Brief 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.
Detailed Description
Type 2 diabetes is a chronic disease. In the United States, an estimated 21 million people have diabetes, with type 2 diabetes occurring in 90% to 95% of cases. Hypertension (high blood pressure) affe...
Eligibility Criteria
Inclusion
- 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
Exclusion
Key Trial Info
Start Date :
June 1 2006
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
May 1 2007
Estimated Enrollment :
96 Patients enrolled
Trial Details
Trial ID
NCT00376181
Start Date
June 1 2006
End Date
May 1 2007
Last Update
June 22 2010
Active Locations (73)
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1
Huntsville, Alabama, United States
2
Tallassee, Alabama, United States
3
Little Rock, Arkansas, United States
4
Auburn, California, United States