Efficacy and Safety of Alogliptin Plus Metformin in Patients With Type 2 Diabetes
Launched by TAKEDA · Dec 1, 2009
Trial Information
Current as of May 13, 2025
Completed
Keywords
ClinConnect Summary
There are approximately 19 million people in the United States who have been diagnosed with diabetes mellitus, of which 90% to 95% are type 2. The prevalence of type 2 diabetes varies among racial and ethnic populations and has been shown to correlate with age, obesity, family history, history of gestational diabetes and physical inactivity. Over the next decade, a marked increase in the number of adults with diabetes mellitus is expected.
Metformin is the usual choice of first-line therapy for type 2 diabetes. Metformin targets insulin resistance in type 2 diabetes by inhibiting hepatic g...
Gender
ALL
Eligibility criteria
- 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.
About Takeda
Takeda Pharmaceutical Company Limited is a global, research-driven biopharmaceutical organization committed to advancing patient care through innovative therapies. Founded in 1781 and headquartered in Osaka, Japan, Takeda focuses on key therapeutic areas including oncology, gastroenterology, neuroscience, and rare diseases. With a strong emphasis on research and development, Takeda leverages cutting-edge science and technology to deliver transformative medicines that address unmet medical needs. The company is dedicated to sustainability and ethical practices, ensuring that its clinical trials uphold the highest standards of safety and efficacy while fostering collaboration with healthcare professionals and communities worldwide.
Contacts
Jennifer Cobb
Immunology at National Institute of Allergy and Infectious Diseases (NIAID)
Locations
Atlanta, Georgia, United States
San Antonio, Texas, United States
San Antonio, Texas, United States
Boca Raton, Florida, United States
Miami, Florida, United States
Chicago, Illinois, United States
St. Louis, Missouri, United States
Charlotte, North Carolina, United States
Cleveland, Ohio, United States
Houston, Texas, United States
South Burlington, Vermont, United States
Milwaukee, Wisconsin, United States
Haifa, , Israel
Holon, , Israel
Bialystok, , Poland
Dallas, Texas, United States
Warszawa, , Poland
Wroclaw, , Poland
Ponce, , Puerto Rico
Moscow, , Russian Federation
Oklahoma City, Oklahoma, United States
Phoenix, Arizona, United States
Orlando, Florida, United States
Lexington, Kentucky, United States
Greensboro, North Carolina, United States
Debrecen, , Hungary
Las Vegas, Nevada, United States
Little Rock, Arkansas, United States
Anaheim, California, United States
El Paso, Texas, United States
Salt Lake City, Utah, United States
Cincinnati, Ohio, United States
Santa Ana, California, United States
Oklahoma City, Oklahoma, United States
Louisville, Kentucky, United States
Omaha, Nebraska, United States
Columbia, South Carolina, United States
Johnson City, Tennessee, United States
Decatur, Georgia, United States
Kalamazoo, Michigan, United States
Mexico City, , Mexico
Cidra, , Puerto Rico
San Juan, , Puerto Rico
Atlanta, Georgia, United States
Houston, Texas, United States
Tulsa, Oklahoma, United States
Arkhangelsk, , Russian Federation
St. Petersburg, , Russian Federation
Donetsk, , Ukraine
Lviv, , Ukraine
Dallas, Texas, United States
Bristol, Tennessee, United States
Hradec Kralove, , Czech Republic
Olomouc, , Czech Republic
Ostrava, , Czech Republic
Iasi, , Romania
Carrollton, Texas, United States
Cincinnati, Ohio, United States
Colorado Springs, Colorado, United States
Vilnius, , Lithuania
Henderson, Nevada, United States
Pretoria, Gauteng, South Africa
Miami, Florida, United States
Greenville, South Carolina, United States
Greenville, South Carolina, United States
Bucharest, , Romania
Colorado Springs, Colorado, United States
Dearborn, Michigan, United States
Ogden, Utah, United States
Zalaegerszeg, , Hungary
Kaunas, , Lithuania
Bytom, , Poland
Bacau, , Romania
Irkutsk, , Russian Federation
Roseville, California, United States
Topeka, Kansas, United States
Asheville, North Carolina, United States
Kfar Saba, , Israel
Lawrenceville, Georgia, United States
Ocala, Florida, United States
Nitra, , Slovakia
Bradenton, Florida, United States
Gallipolis, Ohio, United States
Phoenix, Arizona, United States
Guadalajara, , Mexico
Hialeah, Florida, United States
Monterrey, , Mexico
Kharkiv, , Ukraine
Kyiv, , Ukraine
Flint, Michigan, United States
Santurce, , Puerto Rico
National City, California, United States
Kosice, , Slovakia
Muscle Shoals, Alabama, United States
Searcy, Arkansas, United States
Pembroke Pines, Florida, United States
Spring, Texas, United States
Mesa, Arizona, United States
Pismo Beach, California, United States
Downingtown, Pennsylvania, United States
Tipton, Pennsylvania, United States
Sierra Vista, Arizona, United States
Altoona, Pennsylvania, United States
Ivano Frankivsk, , Ukraine
Gyor, , Hungary
Klaipeda, , Lithuania
Nitra, , Slovakia
Zlin, , Czech Republic
Zilina, , Slovakia
Buena Park, California, United States
Oxon Hill, Maryland, United States
Elizabeth, New Jersey, United States
Bensalem, Pennsylvania, United States
Fleetwood, Pennsylvania, United States
Uniontown, Pennsylvania, United States
Dnipropetrovsk, , Ukraine
North Dartmouth, Massachusetts, United States
Blue Ridge, Georgia, United States
Gyula, , Hungary
Durango, , Mexico
Lauderdale Lakes, Florida, United States
Melrose Park, Illinois, United States
Fargo, North Dakota, United States
Shippensburg, Pennsylvania, United States
Bountiful, Utah, United States
Hayden Lake, Idaho, United States
Panama City, Florida, United States
Katy, Texas, United States
Banska Bystrica, , Slovakia
Lucenec, , Slovakia
Presov, , Slovakia
Dubuque, Iowa, United States
Odessa, Texas, United States
Temple, Texas, United States
Marrero, Louisiana, United States
Chandler, Arizona, United States
Columbia, South Carolina, United States
Johannesburg, Gauteng, South Africa
Cape Town, Western Cape, South Africa
Komarom, , Hungary
Kamieniec Zabkowicki, , Poland
Leczyca, , Poland
Gallipolis, Ohio, United States
Constanta, , Romania
Lawrenceville, New Jersey, United States
Tempe, Arizona, United States
Nahariya, , Israel
Perm, , Russian Federation
Ufa, , Russian Federation
Marrero, Louisiana, United States
Szolnok, , Hungary
Grodzisk Mazowiecki, , Poland
Sahy, , Slovakia
Mexico, Df, , Mexico
Safed, , Israel
Praha 10, , Czech Republic
Picayune, Mississippi, United States
Mooresville, North Carolina, United States
Taylors, South Carolina, United States
Sugarland, Texas, United States
Kedainiai, , Lithuania
Gniewkowo, , Poland
Odesa, , Ukraine
Dothan, Alabama, United States
Pell City, Alabama, United States
Maumee, Ohio, United States
Norman, Oklahoma, United States
Hurst, Texas, United States
Gyongyos, , Hungary
Kemerovo, , Russian Federation
Zaporizhzhya, , Ukraine
Opa Locka, Florida, United States
Mishawaka, Indiana, United States
Presov, , Slovakia
Petersburg, Virginia, United States
Caguas, , Puerto Rico
Mason, Ohio, United States
Decatur, Georgia, United States
Crossville, Tennessee, United States
Distrito Federal, , Mexico
Cuernavaca, , Mexico
Murrells Inlet, South Carolina, United States
Baia Mare, , Romania
Ploiesti, , Romania
Vinnytsya, , Ukraine
Brick, New Jersey, United States
San Juan, , Puerto Rico
Brentwood, Tennessee, United States
North Massapequa, New York, United States
North Myrtle Beach, South Carolina, United States
Council Bluffs, Iowa, United States
Centurion, Gauteng, South Africa
Durban, Kwazulu Natal, South Africa
Perkasie, Pennsylvania, United States
Las Vegas, Nevada, United States
Znojmo, , Czech Republic
Budaors, , Hungary
Acapulco, Guerrero, , Mexico
Mexico City, Mexico, , Mexico
Monclova, Coahuila, , Mexico
Monterrey, Nl, , Mexico
Pachuca, , Mexico
Saltillo, , Mexico
Salinas, , Puerto Rico
Cathedral City, California, United States
Cutler Bay, Florida, United States
La Porte, Indiana, United States
Mckenzie, Tennessee, United States
Spring Hill, Tennessee, United States
Deer Park, Texas, United States
Schertz, Texas, United States
Culiacan, Sinoloa, , Mexico
Durango, Durango, , Mexico
Pachuca, Hidalgo, , Mexico
Tijuana, Baja California, , Mexico
Zapopan, Jalisco, , Mexico
Trujilo Alto, , Puerto Rico
Prievidza, , Slovakia
Patients applied
Trial Officials
Vice President, Clinical Science
Study Director
Takeda
Timeline
First submit
Trial launched
Trial updated
Estimated completion
Not reported
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