A Study to Assess Efficacy, Safety, and Tolerability of AD-4833-536 for the Treatment of Subjects With Type 2 Diabetes and Hypertension.

Condition(s) targeted: Type 2 Diabetes; Hypertension

Intervention: AD-4833-536 (Drug)

Phase: Phase 3

Status: Terminated

Sponsored by: Takeda Global Research & Development Center, Inc.

Official(s) and/or principal investigator(s):
Alfonso Perez, MD, Study Director, Affiliation: TGRD

This is a phase 3 study to evaluate the safety, efficacy and tolerability of AD-4833-536 in subjects with type 2 diabetes and hypertension. Each subject will receive AD-4833-536 or AD-4833 alone. After a 1-week screening period, subjects will be treated for 24 weeks. To determine the effects of treatments on diabetes and high blood pressure, hemoglobin A1c (A1C) will be measured at designated visits and blood pressure will be measured at all visits.

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 and Hypertension.

Study design: Treatment, Randomized, Double-Blind, Dose Comparison, Parallel Assignment, Safety/Efficacy Study

Primary outcome: A1C

Detailed description: This is a phase 3, multi-center, randomized, parallel group, double-blind, placebo-controlled study to evaluate the efficacy, safety, and tolerability of AD-4833-536 in subjects with type 2 diabetes and hypertension. Subjects who qualify for the study must have been treated with a stable regimen of metformin alone or a combination of metformin and sulfonylurea for at least 8 weeks prior to Screening. After a 1 week Screening period, subjects who meet the entry criteria will be randomized to receive AD-4833 alone or AD-4833-536 for 24 weeks of treatment.

Minimum age: 18 Years. Maximum age: N/A. Gender(s): Both.

Criteria:

Inclusion Criteria:

- Subject has type 2 diabetes with A1C > 9. 0 % and < 11. 0%.

- Subject has documented hypertension (SBP > 130 and < 170 mm Hg) at randomization.

- Subject has been on stable diet and exercise program in addition to metformin

monotherapy or in combination with SU for at least 8 weeks.

- Subject is taking no more than 3 antihypertensive agents and stable for at least 4

weeks.

Exclusion Criteria:

- Subject is currently taking an ARB, or is taking or is expected to take the following

medications: diuretics, anti-hypertensives, vasodilators, TZDs, insulin, TCAs, lithium, MAO inhibitors, phenothiazines, diet medications, amphetamines or their derivatives, chronic use of common cold medications or NSAIDS including aspirin or COX-2 inhibitors.

- Subject has a history of MI, cerebrovascular accident (CVA), percutaneous coronary

intervention (PCI), coronary artery bypass graft (CABG) or transient ischemic attack (TIA) within previous 6 months or any history of heart failure, post-MI angina, hypertensive encephalopathy, cerebrovascular accident, or transient ischemic attack.

- Subject has clinically significant cardiac conduction defects (eg, 3rd degree

atrioventricular (AV) block and sick sinus syndrome).

- Subject has type 1 or uncontrolled type 2 diabetes mellitus.

Buenos Aires, Argentina

Santa Fe, Argentina

Cordoba, Argentina

Santiago, Chile

Temuco, Chile

Mexico, DF, Mexico

Guadalajara, Mexico

Arequipa, Peru

Lima, Peru

Lambayeque, Peru

Trujillo, Peru

Tallassee, Alabama, United States

Huntsville, Alabama, United States

Little Rock, Arkansas, United States

Auburn, California, United States

Bakersfield, California, United States

Buena Park, California, United States

Chula Vista, California, United States

Huntington Park, California, United States

Los Gatos, California, United States

Norwalk, California, United States

Orangevale, California, United States

Sacramento, California, United States

Stockton, California, United States

Deerfield Beach, Florida, United States

Hialeah, Florida, United States

Kissimmee, Florida, United States

Marianna, Florida, United States

Miami, Florida, United States

Pembroke Pines, Florida, United States

Winter Haven, Florida, United States

Hollywood, Florida, United States

Jacksonville, Florida, United States

Melbourne, Florida, United States

Augusta, Georgia, United States

Dunwoody, Georgia, United States

Leon, Guanajuato, Mexico

Chicago, Illinois, United States

Bloomington, Indiana, United States

Evansville, Indiana, United States

Zapopan, Jalisco, Mexico

Shawnee Mission, Kansas, United States

Prince Frederick, Maryland, United States

Livonia, Michigan, United States

St. Clair Shores, Michigan, United States

Monterrey, NL, Mexico

Las Vegas, Nevada, United States

Trenton, New Jersey, United States

Albany, New York, United States

Johnson City, New York, United States

Staten Island, New York, United States

Charlotte, North Carolina, United States

Salisbury, North Carolina, United States

Winston-Salem, North Carolina, United States

Marion, Ohio, United States

Oklahoma City, Oklahoma, United States

Buckingham, Pennsylvania, United States

Jeannette, Pennsylvania, United States

Mt. Pleasant, South Carolina, United States

Simpsonville, South Carolina, United States

Bristol, Tennessee, United States

New Tazewell, Tennessee, United States

Dallas, Texas, United States

El Paso, Texas, United States

Euless, Texas, United States

Fort Worth, Texas, United States

Houston, Texas, United States

McKinney, Texas, United States

Midland, Texas, United States

San Antonio, Texas, United States

North Richland Hills, Texas, United States

Falls Church, Virginia, United States

Virginia Beach, Virginia, United States

Starting date: June 2006
Ending date: June 2007
Last updated: November 9, 2007