CKDkb: a knowledge base and platform for drug development against non-alcoholic fatty liver disease

Clinical Trial Details

Trial ID:	L3822
Source ID:	NCT01023581
Associated Drug:	Alogliptin
Title:	Efficacy and Safety of Alogliptin Plus Metformin in Patients With Type 2 Diabetes
Acronym:	AM7D
Status:	COMPLETED
Study Results:	YES
Results:	https://ClinicalTrials.gov/show/NCT01023581/results
Conditions:	Diabetes Mellitus, Type 2
Interventions:	DRUG: Alogliptin\|DRUG: Metformin\|DRUG: Alogliptin Placebo\|DRUG: Metformin Placebo
Outcome Measures:	Primary: 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: Change From Baseline in HbA1c Over Time, The change from Baseline in HbA1c (the concentration of glucose bound to hemoglobin as a percent of the absolute maximum that can be bound) was assessed at Weeks 4, 8, 12, 16 and 20. Least squares means are from an analysis of covariance (ANCOVA) model with treatment and geographic region as fixed effects, and baseline HbA1c as a covariate., Baseline and Weeks 4, 8, 12, 16, and 20.\|Change From Baseline in Fasting Plasma Glucose Over Time, The change from Baseline in fasting plasma glucose was assessed at Weeks 1, 2, 4, 8, 12, 16, 20 and 26. Least Squares Means were from an ANCOVA model with treatment and geographic region as fixed effects, and baseline fasting plasma glucose as a covariate., Baseline and Weeks 1, 2, 4, 8, 12, 16, 20 and 26.
Sponsor/Collaborators:	Sponsor: Takeda
Gender:	ALL
Age:	ADULT, OLDER_ADULT
Phases:	PHASE3
Enrollment:	784
Study Type:	INTERVENTIONAL
Study Designs:	Allocation: RANDOMIZED\|Intervention Model: PARALLEL\|Masking: QUADRUPLE (PARTICIPANT, CARE_PROVIDER, INVESTIGATOR, OUTCOMES_ASSESSOR)\|Primary Purpose: TREATMENT
Start Date:	2009-11
Completion Date:	2011-06
Results First Posted:	2013-03-26
Last Update Posted:	2013-03-26
Locations:	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\|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\|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\|Milwaukee, Wisconsin, United States\|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\|Centurion, Gauteng, South Africa\|Johannesburg, Gauteng, South Africa\|Pretoria, Gauteng, South Africa\|Durban, Kwazulu-Natal, South Africa\|Cape Town, Western Cape, South Africa\|Pretoria, South Africa\|Dnipropetrovsk, Ukraine\|Donetsk, Ukraine\|Ivano-Frankivsk, Ukraine\|Kharkiv, Ukraine\|Kyiv, Ukraine\|Lviv, Ukraine\|Odesa, Ukraine\|Vinnytsya, Ukraine\|Zaporizhzhya, Ukraine
URL:	https://clinicaltrials.gov/show/NCT01023581

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Associated Data

Drug ID	Drug Name	Type	DrugBank ID	Targets	Category	Latest Progress
D089	Metformin	small molecule	DB00331				Details

Clinical Trial Details

Summary

Knowledge Graph

Associated Data

Associated NAFLD Drugs (1)