Efficacy and Safety of Alogliptin Plus Metformin in Patients With Type 2 Diabetes
AM7D
A Multicenter, Randomized, Double-Blind, Placebo-Controlled Study to Determine the Efficacy and Safety of Alogliptin Plus Metformin, Alogliptin Alone, or Metformin Alone in Subjects With Type 2 Diabetes
5 other identifiers
interventional
784
13 countries
201
Brief Summary
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for phase_3 diabetes-mellitus-type-2
Started Nov 2009
201 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
Study Start
First participant enrolled
November 1, 2009
CompletedFirst Submitted
Initial submission to the registry
December 1, 2009
CompletedFirst Posted
Study publicly available on registry
December 2, 2009
CompletedPrimary Completion
Last participant's last visit for primary outcome
June 1, 2011
CompletedStudy Completion
Last participant's last visit for all outcomes
June 1, 2011
CompletedResults Posted
Study results publicly available
March 26, 2013
CompletedMarch 26, 2013
February 1, 2013
1.6 years
December 1, 2009
February 17, 2013
February 17, 2013
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Change From Baseline in Glycosylated Hemoglobin (HbA1c) at Week 26
The change from Baseline to Week 26 in HbA1c (the concentration of glucose bound to hemoglobin as a percent of the absolute maximum that can be bound).
Baseline and Week 26.
Secondary Outcomes (2)
Change From Baseline in HbA1c Over Time
Baseline and Weeks 4, 8, 12, 16, and 20.
Change From Baseline in Fasting Plasma Glucose Over Time
Baseline and Weeks 1, 2, 4, 8, 12, 16, 20 and 26.
Study Arms (7)
Placebo
PLACEBO COMPARATORAlogliptin placebo-matching tablets, orally, twice daily and Metformin placebo-matching capsules, orally, twice daily for up to 26 weeks.
Alogliptin 25 QD
EXPERIMENTALAlogliptin 25 mg, tablets, orally, once daily (QD) and Metformin placebo-matching capsules, orally, twice daily for up to 26 weeks.
Alogliptin 12.5 BID
EXPERIMENTALAlogliptin 12.5 mg, tablets, orally, twice daily (BID) and Metformin placebo-matching capsules, orally, twice daily for up to 26 weeks.
Metformin 500 BID
ACTIVE COMPARATORAlogliptin placebo-matching tablets, orally, twice daily and Metformin 500 mg capsules, orally, twice daily for up to 26 weeks.
Metformin 1000 BID
ACTIVE COMPARATORAlogliptin placebo-matching tablets, orally, twice daily and Metformin 1000 mg capsules, orally, twice daily for up to 26 weeks.
Alogliptin 12.5 BID + Metformin 500 BID
EXPERIMENTALAlogliptin 12.5mg, tablets, orally, twice daily and Metformin 500 mg, capsules, orally, twice daily for up to 26 weeks.
Alogliptin 12.5 BID + Metformin 1000 BID
EXPERIMENTALAlogliptin 12.5 mg, tablets, orally, twice daily and Metformin 1000 mg, capsules, orally, twice daily for up to 26 weeks.
Interventions
Alogliptin tablets.
Metformin capsules
Alogliptin placebo-matching tablets.
Eligibility Criteria
You may qualify if:
- 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.
You may not qualify if:
- 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.
- +2 more criteria
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Takedalead
Study Sites (201)
Unknown Facility
Dothan, Alabama, United States
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Muscle Shoals, Alabama, United States
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Pell City, Alabama, United States
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Chandler, Arizona, United States
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Mesa, Arizona, United States
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Phoenix, Arizona, United States
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Sierra Vista, Arizona, United States
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Tempe, Arizona, United States
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Little Rock, Arkansas, United States
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Searcy, Arkansas, United States
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Tempe, Arkansas, United States
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Anaheim, California, United States
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Buena Park, California, United States
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Cathedral City, California, United States
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National City, California, United States
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Pismo Beach, California, United States
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Roseville, California, United States
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Santa Ana, California, United States
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Colorado Springs, Colorado, United States
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Boca Raton, Florida, United States
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Bradenton, Florida, United States
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Cutler Bay, Florida, United States
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Hialeah, Florida, United States
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Lauderdale Lakes, Florida, United States
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Miami, Florida, United States
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Ocala, Florida, United States
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Opa-locka, Florida, United States
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Orlando, Florida, United States
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Panama City, Florida, United States
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Pembroke Pines, Florida, United States
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Atlanta, Georgia, United States
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Blue Ridge, Georgia, United States
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Decatur, Georgia, United States
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Lawrenceville, Georgia, United States
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Hayden Lake, Idaho, United States
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Chicago, Illinois, United States
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Melrose Park, Illinois, United States
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La Porte, Indiana, United States
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Mishawaka, Indiana, United States
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Council Bluffs, Iowa, United States
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Dubuque, Iowa, United States
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Topeka, Kansas, United States
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Lexington, Kentucky, United States
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Louisville, Kentucky, United States
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Marrero, Louisiana, United States
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Oxon Hill, Maryland, United States
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North Dartmouth, Massachusetts, United States
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Dearborn, Michigan, United States
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Flint, Michigan, United States
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Kalamazoo, Michigan, United States
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Picayune, Mississippi, United States
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St Louis, Missouri, United States
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Omaha, Nebraska, United States
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Henderson, Nevada, United States
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Las Vegas, Nevada, United States
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Brick, New Jersey, United States
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Elizabeth, New Jersey, United States
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North Massapequa, New York, United States
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Asheville, North Carolina, United States
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Charlotte, North Carolina, United States
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Greensboro, North Carolina, United States
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Mooresville, North Carolina, United States
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Fargo, North Dakota, United States
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Cincinnati, Ohio, United States
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Cleveland, Ohio, United States
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Gallipolis, Ohio, United States
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Mason, Ohio, United States
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Maumee, Ohio, United States
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Norman, Oklahoma, United States
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Oklahoma City, Oklahoma, United States
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Tulsa, Oklahoma, United States
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Altoona, Pennsylvania, United States
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Bensalem, Pennsylvania, United States
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Downingtown, Pennsylvania, United States
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Fleetwood, Pennsylvania, United States
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Perkasie, Pennsylvania, United States
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Shippensburg, Pennsylvania, United States
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Tipton, Pennsylvania, United States
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Uniontown, Pennsylvania, United States
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Columbia, South Carolina, United States
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Greenville, South Carolina, United States
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Murrells Inlet, South Carolina, United States
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North Myrtle Beach, South Carolina, United States
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Taylors, South Carolina, United States
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Brentwood, Tennessee, United States
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Bristol, Tennessee, United States
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Crossville, Tennessee, United States
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Johnson City, Tennessee, United States
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McKenzie, Tennessee, United States
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Spring Hill, Tennessee, United States
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Carrollton, Texas, United States
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Dallas, Texas, United States
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Deer Park, Texas, United States
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El Paso, Texas, United States
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Houston, Texas, United States
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Hurst, Texas, United States
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Katy, Texas, United States
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Odessa, Texas, United States
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San Antonio, Texas, United States
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Schertz, Texas, United States
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Spring, Texas, United States
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Sugarland, Texas, United States
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Temple, Texas, United States
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Bountiful, Utah, United States
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Ogden, Utah, United States
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Salt Lake City, Utah, United States
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South Burlington, Vermont, United States
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Petersburg, Virginia, United States
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Milwaukee, Wisconsin, United States
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Hradec Králové, Czechia
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Olomouc, Czechia
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Ostrava, Czechia
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Prague, Czechia
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Zlín, Czechia
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Znojmo, Czechia
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Budaörs, Hungary
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Debrecen, Hungary
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Gyöngyös, Hungary
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Győr, Hungary
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Gyula, Hungary
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Komárom, Hungary
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Szolnok, Hungary
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Zalaegerszeg, Hungary
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Haifa, Israel
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Holon, Israel
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Kfar Saba, Israel
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Nahariya, Israel
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Safed, Israel
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Kaunas, Lithuania
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Kėdainiai, Lithuania
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Klaipėda, Lithuania
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Vilnius, Lithuania
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Acapulco, Guerrero, Mexico
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Cuernavaca, Mexico
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Culiacan, Sinoloa, Mexico
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Distrito Federal, Mexico
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Durango, Mexico
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Durango, Durango, Mexico
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Guadalajara, Mexico
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Mexico City, Mexico
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Mexico City, Mexico, Mexico
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Monclova, Coahuila, Mexico
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Monterrey, Mexico
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Monterrey, NL, Mexico
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Pachuca, Mexico
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Pachuca, Hidalgo, Mexico
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Saltillo, Mexico
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Tijuana, Baja California, Mexico
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Zapopan, Jalisco, Mexico
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Bialystok, Poland
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Bytom, Poland
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Gniewkowo, Poland
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Grodzisk Mazowiecki, Poland
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Kamieniec Ząbkowicki, Poland
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Warsaw, Poland
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Wroclaw, Poland
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Łęczyca, Poland
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Caguas, PR, Puerto Rico
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Cidra, PR, Puerto Rico
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Ponce, PR, Puerto Rico
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Salinas, PR, Puerto Rico
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San Juan, PR, Puerto Rico
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Santurce, PR, Puerto Rico
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San Juan, Puerto Rico
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Trujilo Alto, Puerto Rico
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Bacau, Romania
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Baia Mare, Romania
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Bucharest, Romania
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Constanța, Romania
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Iași, Romania
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Ploieşti, Romania
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Arkhangelsk, Russia
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Irkutsk, Russia
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Kemerovo, Russia
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Moscow, Russia
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Perm, Russia
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Saint Petersburg, Russia
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Ufa, Russia
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Banská Bystrica, Slovakia
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Košice, Slovakia
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Lučenec, Slovakia
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Nitra, Slovakia
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Prešov, Slovakia
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Prievidza, Slovakia
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Šahy, Slovakia
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Žilina, Slovakia
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Centurion, Gauteng, South Africa
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Johannesburg, Gauteng, South Africa
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Pretoria, Gauteng, South Africa
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Durban, KwaZulu-Natal, South Africa
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Cape Town, Western Cape, South Africa
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Pretoria, South Africa
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Dnipropetrovsk, Ukraine
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Donetsk, Ukraine
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Ivano-Frankivsk, Ukraine
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Kharkiv, Ukraine
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Kyiv, Ukraine
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Lviv, Ukraine
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Odesa, Ukraine
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Vinnytsia, Ukraine
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Zaporizhzhya, Ukraine
Related Publications (1)
Pratley RE, Fleck P, Wilson C. Efficacy and safety of initial combination therapy with alogliptin plus metformin versus either as monotherapy in drug-naive patients with type 2 diabetes: a randomized, double-blind, 6-month study. Diabetes Obes Metab. 2014 Jul;16(7):613-21. doi: 10.1111/dom.12258. Epub 2014 Feb 12.
PMID: 24400655DERIVED
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Results Point of Contact
- Title
- Sr. VP, Clinical Science
- Organization
- Takeda Global Research and Development Center, Inc.
Study Officials
- STUDY DIRECTOR
Vice President, Clinical Science
Takeda
Publication Agreements
- PI is Sponsor Employee
- No
- Restriction Type
- OTHER
- Restrictive Agreement
- Yes
Study Design
- Study Type
- interventional
- Phase
- phase 3
- Allocation
- RANDOMIZED
- Masking
- QUADRUPLE
- Who Masked
- PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
December 1, 2009
First Posted
December 2, 2009
Study Start
November 1, 2009
Primary Completion
June 1, 2011
Study Completion
June 1, 2011
Last Updated
March 26, 2013
Results First Posted
March 26, 2013
Record last verified: 2013-02