The purpose of this study is to evaluate the safety and effectiveness of alogliptin combined
with metformin, once daily (QD) or twice daily (BID), in participants with Type 2 Diabetes.
direct interaction with a glucose-dependent insulinotropic peptide - specific receptor on
islet beta cells. The glucose-lowering actions of glucagon-like peptide-1, but not
glucose-dependent insulinotropic peptide, are preserved in patients with type 2 diabetes
mellitus. It is expected that inhibition of dipeptidyl peptidase IV will improve glycemic
(glucose) control in patients with type 2 diabetes.
Based on the potential, complimentary mechanisms of action of alogliptin and metformin, this
study will compare the safety and efficacy of alogliptin and metformin (SYR-322MET) on
improving glycemic control in patients with type 2 diabetes mellitus who are inadequately
controlled by diet adjustment and exercise alone.
Participants taking part in this study will receive dietary and exercise coaching, and will
monitor their own blood glucose concentrations with a home glucose monitor. Participants
will also be required to maintain a hypoglycemic diary throughout the course of the study.
Participation in this study is expected to last up to 34 weeks.
Minimum age: 18 Years.
Maximum age: 80 Years.
Gender(s): Both.
Inclusion Criteria:
- Has historical diagnosis of Type 2 Diabetes Mellitus.
- Has been treated with diet and exercise for at least 2 months prior to Screening, and
has a Glycosylated Hemoglobin concentration between 7. 5% and 10. 0%, inclusive at
Screening.
- Has received less than 7 days of any antidiabetic medication within 2 months prior to
Screening.
- Body mass index greater than or equal to 23 kg/m^2 and less than or equal to 45
kg/m^2 (except for Asian or Asian-descendant subjects for whom the range is between
20 and 35 kg/ m^2, inclusive).
- Fasting C-peptide concentration greater than or equal to 0. 8 ng/mL.
- Regularly using other, non-excluded, medications must be on a stable dose for at
least the 4 weeks prior to Screening.
- Females of childbearing potential and males who are sexually active agree to
routinely use adequate contraception from Screening throughout the duration of the
study.
- Able and willing to monitor their own blood glucose concentrations with a home
glucose monitor and complete patient diaries.
Exclusion Criteria:
- Hemoglobin less than 12 g/dL for males and less than 10 g/dL for females at Screening
Visit.
- Has a history of any hemoglobinopathy that may affect determination of Glycosylated
Hemoglobin.
- Has a history of laser treatment for proliferative diabetic retinopathy within the 6
months prior to Screening.
- Has a history of treatment for diabetic gastric paresis, gastric banding, or gastric
bypass surgery.
- Has a history of diabetic ketoacidosis or hyperosmolar non-ketotic coma.
- Has systolic blood pressure greater than or equal to 150 mmHg and /or diastolic
pressure greater than or equal to 90 mmHg at Screening visit.
- Has New York Heart Association Class III to IV heart failure.
- Has a history of coronary angioplasty, coronary stent placement, coronary bypass
surgery, or myocardial infarction within the 90 days prior to Screening.
- Has Alanine aminotransferase greater than 3 times the upper limit of normal at
Screening.
- Has a history of alcohol or substance abuse with the 2 years prior to Screening.
- Serum creatinine greater than or equal to 1. 5 mg/dL for males and greater than or
equal to 1. 4 mg/dL for females.
- Has history of cancer, other than squamous cell or basal cell carcinoma of the skin
that has not been in full remission for at least 5 years prior to Screening.
- Has a history of infection with human immunodeficiency virus, hepatitis B virus or
hepatitis C virus.
- Has any major illness or debility that in the investigator's opinion prohibits the
subject from completing the study.
- Has received any investigational drug within the 90 days prior to Screening.
- Has a history of hypersensitivity or allergy to alogliptin, other DPP-4 inhibitors,
metformin or related compounds.
- Has used oral or systematically injected glucocorticoids or weight loss drugs prior
to 2 months to screening.
Hradec Kralove, Czech Republic
Olomouc, Czech Republic
Ostrava, Czech Republic
Praha 10, Czech Republic
Zlin, Czech Republic
Znojmo, Czech Republic
Budaors, Hungary
Debrecen, Hungary
Gyongyos, Hungary
Gyor, Hungary
Gyula, Hungary
Komarom, Hungary
Szolnok, Hungary
Zalaegerszeg, Hungary
Haifa, Israel
Holon, Israel
Kfar Saba, Israel
Nahariya, Israel
Safed, Israel
Kaunas, Lithuania
Kedainiai, Lithuania
Klaipeda, Lithuania
Vilnius, Lithuania
Acapulco, Guerrero, Mexico
Cuernavaca, Mexico
Culiacan, Sinoloa, Mexico
Distrito Federal, Mexico
Durango, Durango, Mexico
Durango, Mexico
Guadalajara, Mexico
Mexico City, Mexico, Mexico
Mexico City, Mexico
Mexico, DF, Mexico
Monclova, Coahuila, Mexico
Monterrey, NL, Mexico
Monterrey, Mexico
Pachuca, Hidalgo, Mexico
Pachuca, Mexico
Saltillo, Mexico
Tijuana, Baja California, Mexico
Zapopan, Jalisco, Mexico
Bialystok, Poland
Bytom, Poland
Gniewkowo, Poland
Grodzisk Mazowiecki, Poland
Kamieniec Zabkowicki, Poland
Leczyca, Poland
Warszawa, Poland
Wroclaw, Poland
Caguas, Puerto Rico
Cidra, Puerto Rico
Ponce, Puerto Rico
Salinas, Puerto Rico
San Juan, Puerto Rico
Santurce, Puerto Rico
Trujilo Alto, Puerto Rico
Bacau, Romania
Baia Mare, Romania
Bucharest, Romania
Constanta, Romania
Iasi, Romania
Ploiesti, Romania
Arkhangelsk, Russian Federation
Irkutsk, Russian Federation
Kemerovo, Russian Federation
Moscow, Russian Federation
Perm, Russian Federation
St. Petersburg, Russian Federation
Ufa, Russian Federation
Banska Bystrica, Slovakia
Kosice, Slovakia
Lucenec, Slovakia
Nitra, Slovakia
Presov, Slovakia
Prievidza, Slovakia
Sahy, Slovakia
Zilina, Slovakia
Pretoria, South Africa
Dnipropetrovsk, Ukraine
Donetsk, Ukraine
Ivano-Frankivsk, Ukraine
Kharkiv, Ukraine
Kyiv, Ukraine
Lviv, Ukraine
Odesa, Ukraine
Vinnytsya, Ukraine
Zaporizhzhya, Ukraine
Dothan, Alabama, United States
Muscle Shoals, Alabama, United States
Pell City, Alabama, United States
Chandler, Arizona, United States
Mesa, Arizona, United States
Phoenix, Arizona, United States
Sierra Vista, Arizona, United States
Tempe, Arizona, United States
Little Rock, Arkansas, United States
Searcy, Arkansas, United States
Tempe, Arkansas, United States
Anaheim, California, United States
Buena Park, California, United States
Cathedral City, California, United States
National City, California, United States
Pismo Beach, California, United States
Roseville, California, United States
Santa Ana, California, United States
Colorado Springs, Colorado, United States
Boca Raton, Florida, United States
Bradenton, Florida, United States
Cutler Bay, Florida, United States
Hialeah, Florida, United States
Lauderdale Lakes, Florida, United States
Miami, Florida, United States
Ocala, Florida, United States
Opa Locka, Florida, United States
Orlando, Florida, United States
Panama City, Florida, United States
Pembroke Pines, Florida, United States
Centurion, Gauteng, South Africa
Johannesburg, Gauteng, South Africa
Pretoria, Gauteng, South Africa
Atlanta, Georgia, United States
Blue Ridge, Georgia, United States
Decatur, Georgia, United States
Lawrenceville, Georgia, United States
Hayden Lake, Idaho, United States
Chicago, Illinois, United States
Melrose Park, Illinois, United States
La Porte, Indiana, United States
Mishawaka, Indiana, United States
Council Bluffs, Iowa, United States
Dubuque, Iowa, United States
Topeka, Kansas, United States
Lexington, Kentucky, United States
Louisville, Kentucky, United States
Durban, Kwazulu-Natal, South Africa
Marrero, Louisiana, United States
Oxon Hill, Maryland, United States
North Dartmouth, Massachusetts, United States
Dearborn, Michigan, United States
Flint, Michigan, United States
Kalamazoo, Michigan, United States
Picayune, Mississippi, United States
St. Louis, Missouri, United States
Omaha, Nebraska, United States
Henderson, Nevada, United States
Las Vegas, Nevada, United States
Brick, New Jersey, United States
Elizabeth, New Jersey, United States
North Massapequa, New York, United States
Asheville, North Carolina, United States
Charlotte, North Carolina, United States
Greensboro, North Carolina, United States
Mooresville, North Carolina, United States
Fargo, North Dakota, United States
Cincinnati, Ohio, United States
Cleveland, Ohio, United States
Gallipolis, Ohio, United States
Mason, Ohio, United States
Maumee, Ohio, United States
Norman, Oklahoma, United States
Oklahoma City, Oklahoma, United States
Tulsa, Oklahoma, United States
Altoona, Pennsylvania, United States
Bensalem, Pennsylvania, United States
Downingtown, Pennsylvania, United States
Fleetwood, Pennsylvania, United States
Perkasie, Pennsylvania, United States
Shippensburg, Pennsylvania, United States
Tipton, Pennsylvania, United States
Uniontown, Pennsylvania, United States
Columbia, South Carolina, United States
Greenville, South Carolina, United States
Murrells Inlet, South Carolina, United States
North Myrtle Beach, South Carolina, United States
Taylors, South Carolina, United States
Brentwood, Tennessee, United States
Bristol, Tennessee, United States
Crossville, Tennessee, United States
Johnson City, Tennessee, United States
McKenzie, Tennessee, United States
Spring Hill, Tennessee, United States
Carrollton, Texas, United States
Dallas, Texas, United States
Deer Park, Texas, United States
El Paso, Texas, United States
Houston, Texas, United States
Hurst, Texas, United States
Katy, Texas, United States
Odessa, Texas, United States
San Antonio, Texas, United States
Schertz, Texas, United States
Spring, Texas, United States
Sugarland, Texas, United States
Temple, Texas, United States
Bountiful, Utah, United States
Ogden, Utah, United States
Salt Lake City, Utah, United States
South Burlington, Vermont, United States
Petersburg, Virginia, United States
Cape Town, Western Cape, South Africa
Milwaukee, Wisconsin, United States