The purpose of this study was to evaluate the antihypertensive and antiglycemic effects, as
well as the safety and tolerability of TAK-491 (azilsartan medoxomil), once daily (QD), in
stage 1 hypertensive, type 2 diabetes mellitus (T2DM) participants whose glycemic control
was inadequate on metformin alone.
Change From Baseline in Glycosylated Hemoglobin (HbA1c)Change From Baseline in Trough Sitting Clinic Diastolic Blood Pressure
Change From Baseline in the 24-hour Mean Systolic Blood Pressure, as Measured by Ambulatory Blood Pressure Monitoring
Change From Baseline in the 24-hour Mean Diastolic Blood Pressure, as Measured by Ambulatory Blood Pressure Monitoring
Change From Baseline in the Mean Daytime (6 AM to 10 PM) Systolic Blood Pressure, as Measured by Ambulatory Blood Pressure Monitoring
Change From Baseline in the Mean Daytime (6 AM to 10 PM) Diastolic Blood Pressure, as Measured by Ambulatory Blood Pressure Monitoring
Change From Baseline in the Mean Nighttime (12 AM to 6 AM) Systolic Blood Pressure, as Measured by Ambulatory Blood Pressure Monitoring
Change From Baseline in the Mean Nighttime (12 AM to 6 AM) Diastolic Blood Pressure, as Measured by Ambulatory Blood Pressure Monitoring
Change From Baseline in the 12-hr Mean Systolic Blood Pressure Measured by Ambulatory Blood Pressure Monitoring
Change From Baseline in the 12-hr Mean Diastolic Blood Pressure Measured by Ambulatory Blood Pressure Monitoring
Change From Baseline in the Trough (22 to 24 Hours After Dosing) Systolic Blood Pressure as Measured by Ambulatory Blood Pressure Monitoring
Change From Baseline in the Trough (22 to 24 Hours After Dosing) Diastolic Blood Pressure as Measured by Ambulatory Blood Pressure Monitoring
Percentage of Participants Requiring Rescue Glycemic Therapy
Time to First Glycemic Rescue
Change From Baseline in HbA1c
Change From Baseline in Fasting Plasma Glucose
Change From Baseline to Week 6 and Week 24 in 2h Glucose During Oral Glucose Tolerance Testing (OGTT)
Change From Baseline to Week 6 and Week 24 in the Area Under the Plasma Concentration-time Curve (AUC) for Glucose During OGTT
Change From Baseline to Week 6 and Week 24 in AUC for Insulin During OGTT
Change From Baseline to Week 6 and Week 24 in AUC for C-peptide During OGTT
Change From Baseline to Week 6 and Week 24 in AUC for Insulin/Glucose Ratio During OGTT
Change From Baseline to Week 6 and Week 24 in AUC for Glucagon During OGTT
Minimum age: 18 Years.
Maximum age: N/A.
Gender(s): Both.
Birmingham, Alabama, United States
Green Valley, Arizona, United States
Tempe, Arizona, United States
Tucson, Arizona, United States
Buena Park, California, United States
Hawaiian Gardens, California, United States
Norwalk, California, United States
Paramount, California, United States
Rancho Cucamonga, California, United States
Sacramento, California, United States
San Diego, California, United States
Tustin, California, United States
Denver, Colorado, United States
Bradenton, Florida, United States
Brooksville, Florida, United States
Hallandale Beach, Florida, United States
Jupiter, Florida, United States
Miami, Florida, United States
Orlando, Florida, United States
Pembroke Pines, Florida, United States
St Petersburg, Florida, United States
Tampa, Florida, United States
Winter Park, Florida, United States
Roswell, Georgia, United States
Chicago, Illinois, United States
Evergreen Park, Illinois, United States
Gurnee, Illinois, United States
Avon, Indiana, United States
Greenfield, Indiana, United States
Lexington, Kentucky, United States
Paducah, Kentucky, United States
Baltimore, Maryland, United States
Columbia, Missouri, United States
Omaha, Nebraska, United States
Las Vegas, Nevada, United States
Margate, New Jersey, United States
Albuquerque, New Mexico, United States
Brooklyn, New York, United States
Calabash, North Carolina, United States
Greensboro, North Carolina, United States
Lenoir, North Carolina, United States
Morehead City, North Carolina, United States
Salisbury, North Carolina, United States
Wilmington, North Carolina, United States
Winston-Salem, North Carolina, United States
Centerville, Ohio, United States
Cincinnati, Ohio, United States
Oklahoma City, Oklahoma, United States
Downingtown, Pennsylvania, United States
Fleetwood, Pennsylvania, United States
Reading, Pennsylvania, United States
Providence, Rhode Island, United States
Anderson, South Carolina, United States
Chattanooga, Tennessee, United States
Kingsport, Tennessee, United States
Nashville, Tennessee, United States
Dallas, Texas, United States
Houston, Texas, United States
Irving, Texas, United States
North Richland Hills, Texas, United States
Pearland, Texas, United States
San Antonio, Texas, United States
Salt Lake City, Utah, United States
Burke, Virginia, United States
Manassas, Virginia, United States
Richmond, Virginia, United States
Virginia Beach, Virginia, United States
Wauwatosa, Wisconsin, United States