Efficacy, Safety and Tolerability of Pioglitazone-Azilsartan in Subjects With Type 2 Diabetes Mellitus
|Type 2 Diabetes||Drug: Pioglitazone and Azilsartan Drug: Pioglitazone||Phase 3|
|Study Design:||Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double Blind (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
|Official Title:||A Phase 3 Double-Blind, Randomized, Placebo-Controlled Study to Determine the Efficacy, Safety, and Tolerability of AD-4833-536 in the Treatment of Subjects With Type 2 Diabetes|
- Change from Baseline in Glycosylated Hemoglobin. [ Time Frame: Baseline and Week 24 ]The change between the value of Glycosylated Hemoglobin (the concentration of glucose bound to hemoglobin as a percent of the absolute maximum that can be bound) collected at week 24 or including final visit, and Glycosylated Hemoglobin collected at baseline.
- Change from Baseline in Diastolic Blood Pressure [ Time Frame: Baseline and Weeks 4, 8, 12, 16, 20, and 24. ]The change between Diastolic Blood Pressure measured at each week indicated including final visit and Diastolic Blood Pressure measured at baseline.
- Change from Baseline in Systolic Blood Pressure [ Time Frame: Baseline and Weeks 4, 8, 12, 16, 20, and 24 ]The change between Systolic Blood Pressure measured at each week indicated including final visit and Systolic Blood Pressure measured at baseline.
|Study Start Date:||June 2006|
|Study Completion Date:||May 2007|
|Primary Completion Date:||May 2007 (Final data collection date for primary outcome measure)|
|Experimental: Pioglitazone 45 mg/Azilsartan 20 mg QD||
Drug: Pioglitazone and Azilsartan
Pioglitazone 45 mg and Azilsartan 20 mg combination tablets, orally, once daily for up to 24 weeks.
|Experimental: Pioglitazone 45 mg/Azilsartan 40 mg QD||
Drug: Pioglitazone and Azilsartan
Pioglitazone 45 mg and Azilsartan 40 mg combination tablets, orally, once daily for up to 24 weeks.
|Active Comparator: Pioglitazone 45 mg QD||
Pioglitazone 45 mg, tablets, orally, once daily for up to 24 weeks.
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) affects approximately 50 million individuals in the United States. The association of diabetes and hypertension is increased in this population; hypertension is more common in persons with diabetes while individuals with hypertension are 2.5 times more likely to develop diabetes than those who have normal blood pressure. As a result, more than 70% of adults with diabetes have hypertension (defined as having blood pressure greater than or equal to 130/80 mm Hg or using prescription medication for hypertension).
Patients with type 2 diabetes and hypertension are at high risk of other illnesses and death. Diabetes and hypertension are associated with insulin resistance (normal amounts of insulin are no adequate to produce a normal insulin response from fat, muscle and liver cells). and hyperinsulinemia (excess levels of insulin in the blood), which are independent risk factors for cardiovascular (heart vessel) disease. Individuals with type 2 diabetes carry a 2 to 4- time greater risk of cardiovascular disease and stroke compared with the general population. Uncontrolled hypertension also is associated with an increased risk of cardiovascular disease and stroke.
Takeda Global Research and Development Center, Inc. is developing a fixed-dose combination product, AD-4833-536. AD-4833-536 is a combination of AD-4833 (pioglitazone) and TAK-536 (azilsartan). Pioglitazone is an oral antidiabetic agent that acts by reducing insulin resistance and approved for treatment of adult patients with type 2 diabetes mellitus. Azilsartan is a angiotensin II receptor blocker that modulates the renin-angiotensin-aldosterone system that regulates blood pressure.
Please refer to this study by its ClinicalTrials.gov identifier: NCT00376181
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|Study Director:||VP Clinical Science Strategy||Takeda|