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

Clinical Trial Details

Trial ID:	L4984
Source ID:	NCT00856284
Associated Drug:	Alogliptin
Title:	Efficacy and Safety of Alogliptin Plus Metformin Compared to Glipizide Plus Metformin in Patients With Type 2 Diabetes Mellitus
Acronym:	ENDURE
Status:	COMPLETED
Study Results:	YES
Results:	https://ClinicalTrials.gov/show/NCT00856284/results
Conditions:	Type 2 Diabetes Mellitus
Interventions:	DRUG: Alogliptin\|DRUG: Metformin\|DRUG: Glipizide
Outcome Measures:	Primary: Change From Baseline in Glycosylated Hemoglobin (HbA1c) at Week 52, The change from Baseline to Week 52 in HbA1c (the concentration of glucose bound to hemoglobin as a percent of the absolute maximum that can be bound). The least squares (LS) means are from an analysis of covariance (ANCOVA) model with treatment, study schedule, and geographic region as class variables, and Baseline metformin dose and Baseline HbA1c as covariates., Baseline and Week 52\|Change From Baseline in Glycosylated Hemoglobin (HbA1c) at Week 104, The change from Baseline to Week 104 in HbA1c (the concentration of glucose bound to hemoglobin as a percent of the absolute maximum that can be bound). The least squares (LS) means are from an analysis of covariance (ANCOVA) model with treatment, study schedule, and geographic region as class variables, and Baseline metformin dose and Baseline HbA1c as covariates., Baseline and Week 104 \| Secondary: Change From Baseline in Glycosylated Hemoglobin at Other Time Points, The change from Baseline over time in HbA1c (the concentration of glucose bound to hemoglobin as a percent of the absolute maximum that can be bound). LS means are from an ANCOVA model with treatment, study schedule, and geographic region as class variables, and Baseline metformin dose and Baseline HbA1c as covariates., Baseline and Weeks 4, 8, 12, 16, 20, 26, 39, 65, 78, and 91.\|Change From Baseline in Fasting Plasma Glucose Over Time, The change from Baseline in fasting plasma glucose (FPG) was assessed at Weeks 2, 4, 8, 12, 16, 20, 26, 39, 52, 65, 78, 91, and 104. LS means are from an ANCOVA model with treatment, study schedule, and geographic region as class variables, and Baseline FPG and Baseline metformin dose as covariates., Baseline and Weeks 2, 4, 8, 12, 16, 20, 26, 39, 52, 65, 78, 91, and 104.\|Percentage of Participants With Glycosylated Hemoglobin Less Than or Equal to 6.5%, The percentage of participants with HbA1c less than or equal to 6.5% at Weeks 26, 52, 78, and 104. Participants who did not complete the scheduled Week 104 visit were assessed based on their response at the time of discontinuation., Weeks 26, 52, 78, and 104.\|Percentage of Participants With Glycosylated Hemoglobin Less Than or Equal to 7.0%, Percentage of participants with HbA1c ≤ 7.0% at Weeks 26, 52, 78, and 104. Participants who did not complete the scheduled Week 104 visit were assessed based on their response at the time of discontinuation., Weeks 26, 52, 78, and 104.\|Change From Baseline in Body Weight Over Time, LS Means are from an ANCOVA model with treatment, study schedule and geographic region as class variables, and Baseline weight and Baseline metformin dose as covariates., Baseline and Weeks 12, 26, 39, 52, 65, 78, 91, and 104.
Sponsor/Collaborators:	Sponsor: Takeda
Gender:	ALL
Age:	ADULT, OLDER_ADULT
Phases:	PHASE3
Enrollment:	2639
Study Type:	INTERVENTIONAL
Study Designs:	Allocation: RANDOMIZED\|Intervention Model: PARALLEL\|Masking: DOUBLE (PARTICIPANT, INVESTIGATOR)\|Primary Purpose: TREATMENT
Start Date:	2009-03
Completion Date:	2012-10
Results First Posted:	2013-12-03
Last Update Posted:	2013-12-03
Locations:	Montgomery, Alabama, United States\|Muscle Shoals, Alabama, United States\|Pell City, Alabama, United States\|Mesa, Arizona, United States\|Peoria, Arizona, United States\|Phoenix, Arizona, United States\|Sierra Vista, Arizona, United States\|Tempe, Arizona, United States\|Tucson, Arizona, United States\|Anaheim, California, United States\|Artesia, California, United States\|Chico, California, United States\|Los Alamitos, California, United States\|Mission Viejo, California, United States\|National City, California, United States\|Northridge, California, United States\|Pismo Beach, California, United States\|Riverside, California, United States\|Roseville, California, United States\|Sacramento, California, United States\|San Diego, California, United States\|Santa Monica, California, United States\|Tustin, California, United States\|Arvada, Colorado, United States\|Colorado Springs, Colorado, United States\|Ridgefield, Connecticut, United States\|Waterbury, Connecticut, United States\|Brooksville, Florida, United States\|New Port Richey, Florida, United States\|North Miami Beach, Florida, United States\|Ocala, Florida, United States\|Opa Locka, Florida, United States\|Orlando, Florida, United States\|Augusta, Georgia, United States\|Savannah, Georgia, United States\|Addison, Illinois, United States\|Chicago, Illinois, United States\|Bloomington, Indiana, United States\|Evansville, Indiana, United States\|Indianapolis, Indiana, United States\|Mishawaka, Indiana, United States\|South Bend, Indiana, United States\|Lexington, Kentucky, United States\|Munfordville, Kentucky, United States\|Marrero, Louisiana, United States\|Bangor, Maine, United States\|Elkridge, Maryland, United States\|Oxon Hill, Maryland, United States\|North Dartmouth, Massachusetts, United States\|Ann Arbor, Michigan, United States\|Flint, Michigan, United States\|Picayune, Mississippi, United States\|Springfield, Missouri, United States\|St Peters, Missouri, United States\|St. Louis, Missouri, United States\|Omaha, Nebraska, United States\|Las Vegas, Nevada, United States\|Albuquerque, New Mexico, United States\|New Windsor, New York, United States\|New York, New York, United States\|Rochester, New York, United States\|Fargo, North Dakota, United States\|Beachwood, Ohio, United States\|Cincinnati, Ohio, United States\|Dayton, Ohio, United States\|Willoughby Hills, Ohio, United States\|Zanesville, Ohio, United States\|Norman, Oklahoma, United States\|Oklahoma City, Oklahoma, United States\|Medford, Oregon, United States\|Havertown, Pennsylvania, United States\|Norristown, Pennsylvania, United States\|Philadelphia, Pennsylvania, United States\|Pittsburgh, Pennsylvania, United States\|Tipton, Pennsylvania, United States\|Anderson, South Carolina, United States\|Charleston, South Carolina, United States\|Greer, South Carolina, United States\|Rapid City, South Dakota, United States\|New Tazewell, Tennessee, United States\|Arlington, Texas, United States\|Carrollton, Texas, United States\|Dallas, Texas, United States\|Fort Worth, Texas, United States\|Houston, Texas, United States\|Hurst, Texas, United States\|Katy, Texas, United States\|San Antonio, Texas, United States\|Spring, Texas, United States\|Temple, Texas, United States\|Midvale, Utah, United States\|Hampton, Virginia, United States\|Lewisburg, West Virginia, United States\|Milwaukee, Wisconsin, United States\|Mar del Plata, Argentina\|Garran, Australian Capital Territory, Australia\|Wollongong, New South Wales, Australia\|Herston, Queensland, Australia\|Nedlands, Western Australia, Australia\|Graz, Austria\|Salzburg, Austria\|Recife, Pernambuco, Brazil\|Brasília - DF, Planalto Central, Brazil\|Mogi das Cruzes, São Paulo, Brazil\|Fortaleza, Brazil\|São Paulo, Brazil\|St. John's, Newfoundland and Labrador, Canada\|Brampton, Ontario, Canada\|Collingwood, Ontario, Canada\|Corunna, Ontario, Canada\|Etobichoke, Ontario, Canada\|Etobicoke, Ontario, Canada\|Mississauga, Ontario, Canada\|Smith Falls, Ontario, Canada\|Smiths Falls, Ontario, Canada\|Toronto, Ontario, Canada\|Granby, Quebec, Canada\|Montreal, Quebec, Canada\|Providencia, Santiago, Chile\|Santiago, Chile\|Potsdam, Brandenburg, Germany\|Kelkheim, Hesse, Germany\|Offenbach, Hesse, Germany\|Münster, North Rhine-Westphalia, Germany\|Mainz, Rhineland-Palatinate, Germany\|Neuwied, Rhineland-Palatinate, Germany\|Rhaunen, Rhineland-Palatinate, Germany\|Guatemala City, Guatemala\|Wong Tai Sin, Kowloon, Hong Kong\|Pok Fu Lam, Southern District, Hong Kong\|Kowloon, Hong Kong\|Pécs, Baranya, Hungary\|Miskolc, Borsod-Abaúj-Zemplén, Hungary\|Kalocsa, Bács-Kiskun, Hungary\|Gyula, Békés, Hungary\|Makó, Csongrád, Hungary\|Szentes, Csongrád, Hungary\|Nyíregyháza, Szabolcs-Szatmár-Bereg, Hungary\|Zalaegerszeg, Zala, Hungary\|Budapest, Hungary\|Hyderabad, Andhra Pradesh, India\|Patna, Bihar, India\|Karnal, Haryana, India\|Bangalore, Karnataka, India\|Belgaum, Karnataka, India\|Bhopal, Madhya Pradesh, India\|Mumbai, Maharashtra, India\|Trichy, Tamil Nadu, India\|Kfar-Saba, Center District, Israel\|Kfar Saba, Central District, Israel\|Matan, Central District, Israel\|Petach Tikva, Central District, Israel\|Hadera, Haifa District, Israel\|Haifa, Haifa District, Israel\|Nahariya, Northern District, Israel\|Safed, Northern District, Israel\|Ashkelon, Southern District, Israel\|Be'er Sheva, Southern District, Israel\|Holon, Tel Aviv, Israel\|Tel- Aviv, Tel Aviv, Israel\|Jerusalem, Israel\|Zefat, Israel\|Milano, Milan, Italy\|Perugia, Italy\|Pistoia, Italy\|Gwangju, Honam, Korea, Republic of\|Daejeon, Hoseo, Korea, Republic of\|Daegu, Yeongnam, Korea, Republic of\|Daugavpils, Latvia\|Liepaja, Latvia\|Limbazi, Latvia\|Ogre, Latvia\|Riga, Latvia\|Talsi, Latvia\|Tukums, Latvia\|Valmiera, Latvia\|Alytus, Lithuania\|Kaunas, Lithuania\|Kedainiai, Lithuania\|Klaipeda, Lithuania\|Palanga, Lithuania\|Panevezys, Lithuania\|Vilnius, Lithuania\|Ipoh, Malaysia\|Kajang, Malaysia\|Kota Bahru, Malaysia\|Kota Bharu, Malaysia\|Kuala Terengganu, Malaysia\|Kuantan, Malaysia\|Melaka, Malaysia\|Taiping, Malaysia\|Mexico, Distrito Federal, Mexico\|Tlalnepantla, Edo de Mexico, Mexico\|Guadalajara, Jalisco, Mexico\|Monterrey, Nuevo Leon, Mexico\|Huixquilucan Edo. de Mexico, Mexico\|Mexico City, Mexico\|Auckland, New Zealand\|Christchurch, New Zealand\|Hamilton, New Zealand\|Otahuhu, New Zealand\|Palmerston North, New Zealand\|Takapuna, New Zealand\|Tauranga, New Zealand\|Wellington, New Zealand\|Chiclayo, Lambayeque, Peru\|Lima, San Juan de Miraflores, Peru\|Ica, Peru\|Manila, Philippines\|Bytom, Poland\|Gniewkowo, Poland\|Krakow, Poland\|Radom, Poland\|Rzeszow, Poland\|Tychy, Poland\|Warszawa, Poland\|Ponce, Puerto Rico\|San Juan, Puerto Rico\|Bacau, Romania\|Bucharest, Romania\|Galati, Romania\|Oradea, Romania\|Sibiu, Romania\|Targu Mures, Romania\|Arkhangelsk, Russian Federation\|Irkutsk, Russian Federation\|Moscow, Russian Federation\|Samara, Russian Federation\|Smolensk, Russian Federation\|St Petersburg, Russian Federation\|Yaroslavl, Russian Federation\|Singapore, Singapore\|Port Elizabeth, Eastern Cape, South Africa\|Johannesburg, Gauteng, South Africa\|Pretoria, Gauteng, South Africa\|Durban, Kwazulu-Natal, South Africa\|Tongaat, Kwazulu-Natal, South Africa\|Cape Town, Western Cape, South Africa\|Barcelona, Cataluña, Spain\|Santiago de Compostela, Galicia, Spain\|Alicante, Spain\|Amphure Muang, Thailand\|Bangkok, Thailand\|Chiangmai, Thailand\|Khon Kaen, Thailand\|Dnepropertovsk, Ukraine\|Dnipropetrovsk, Ukraine\|Donetsk, Ukraine\|Kharkiv, Ukraine\|Kyiv, Ukraine\|Lviv, Ukraine\|Vinnytsa, Ukraine\|Vinnytsya, Ukraine\|Zaporizhye, Ukraine\|Zaporizhzhya, Ukraine\|Aintree-Liverpool, United Kingdom\|Bath, United Kingdom\|Bournemouth, United Kingdom\|Dundee, United Kingdom\|London, United Kingdom\|Stevenage, United Kingdom\|Swansea, United Kingdom
URL:	https://clinicaltrials.gov/show/NCT00856284

Knowledge Graph
Associated Data

Drug ID	Drug Name	Type	DrugBank ID	Targets	Category	Latest Progress
D089	Metformin	small molecule	DB00331				Details
D317	Glipizide	small molecule	DB01067				Details

Clinical Trial Details

Summary

Knowledge Graph

Associated Data

Associated NAFLD Drugs (2)