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Clinical Trial Details

Trial ID: L3730
Source ID: NCT02471404
Associated Drug: Dapagliflozin
Title: Efficacy and Safety of Dapagliflozin and Dapagliflozin Plus Saxagliptin in Combination With Metformin in Type 2 Diabetes Patients Compared With Sulphonylurea
Acronym:
Status: COMPLETED
Study Results: YES
Results: https://ClinicalTrials.gov/show/NCT02471404/results
Conditions: Type 2 Diabetes Mellitus|Inadequate Glycaemic Control
Interventions: DRUG: Dapagliflozin|DRUG: Saxagliptin|DRUG: Glimepiride|DRUG: Placebo for dapagliflozin|DRUG: Placebo for saxagliptin|DRUG: Placebo for glimepiride
Outcome Measures: Primary: Change in Haemoglobin A1c (HbA1c) From Baseline to Week 52, Change in HbA1c from baseline (week 0) to week 52., Baseline, week 52. Values recorded after rescue treatment or collected more than 8 days after the last dose date were excluded from the analysis | Secondary: Patients With at Least One Episode of Confirmed Hypoglycaemia, Percentage of patients reporting at least 1 episode of hypoglycaemia (symptomatic + blood glucose \<=50 mg/dL) during the double-blind treatment period, Up to Week 52. Values recorded after rescue treatment or collected more than 8 days after the last dose date were excluded from the analysis|Change in Total Body Weight From Baseline at Week 52, Change in body weight from baseline (week 0) to week 52, Baseline, week 52. Values recorded after rescue treatment or collected more than 8 days after the last dose date were excluded from the analysis|Change in Fasting Plasma Glucose (FPG) From Baseline to Week 52, Change in FPG from baseline (week 0) to week 52, Baseline, week 52. Values recorded after rescue treatment or collected more than 8 days after the last dose date were excluded from the analysis|Time to Rescue, The time to rescue (from first dose date after randomisation to start of rescue medication or discontinuation due to lack of glycaemic control) during the 52 week double blind treatment period, Over the 52 week treatment period|Number of Patients Rescued, Number (%) of patients rescued., Over the 52 week treatment period
Sponsor/Collaborators: Sponsor: AstraZeneca
Gender: ALL
Age: ADULT, OLDER_ADULT
Phases: PHASE4
Enrollment: 939
Study Type: INTERVENTIONAL
Study Designs: Allocation: RANDOMIZED|Intervention Model: PARALLEL|Masking: TRIPLE (PARTICIPANT, CARE_PROVIDER, INVESTIGATOR)|Primary Purpose: TREATMENT
Start Date: 2015-09-21
Completion Date: 2017-03-13
Results First Posted: 2019-03-26
Last Update Posted: 2019-03-26
Locations: Research Site, Hodonin, 695 01, Czechia|Research Site, Hradec Kralove, 500 05, Czechia|Research Site, Jilove u Prahy, 254 01, Czechia|Research Site, Ostrava - Belsky les, 700 30, Czechia|Research Site, Pardubice, 530 02, Czechia|Research Site, Plzen - Severni Predmesti, 301 00, Czechia|Research Site, Praha - Klanovice, 190 14, Czechia|Research Site, Prelouc, 535 01, Czechia|Research Site, Uherske Hradiste, 686 01, Czechia|Research Site, Zlin, 760 01, Czechia|Research Site, Aschaffenburg, 63739, Germany|Research Site, Bad Homburg, 61348, Germany|Research Site, Bad Mergentheim, 97980, Germany|Research Site, Bad Nauheim, 61231, Germany|Research Site, Bad Neuenahr-Ahrweiler, 53474, Germany|Research Site, Bad Oeynhausen, 32545, Germany|Research Site, Bad Reichenhall, 83435, Germany|Research Site, Berlin, 10115, Germany|Research Site, Berlin, 10409, Germany|Research Site, Berlin, 10629, Germany|Research Site, Berlin, 10787, Germany|Research Site, Berlin, 12627, Germany|Research Site, Berlin, 13125, Germany|Research Site, Berlin, 13597, Germany|Research Site, Bochum, 44787, Germany|Research Site, Bochum, 44869, Germany|Research Site, Bonn, 53179, Germany|Research Site, Bünde, 32257, Germany|Research Site, Daaden, 57567, Germany|Research Site, Darmstadt, 64295, Germany|Research Site, Datteln, 45711, Germany|Research Site, Deggingen, 73326, Germany|Research Site, Dippoldiswalde, 01744, Germany|Research Site, Dortmund, 44137, Germany|Research Site, Dresden, 01309, Germany|Research Site, Duisburg, 47179, Germany|Research Site, Erfurt, 99085, Germany|Research Site, Erlangen, 91052, Germany|Research Site, Eschweiler, 52249, Germany|Research Site, Essen, 45136, Germany|Research Site, Essen, 45355, Germany|Research Site, Essen, 45359, Germany|Research Site, Frankfurt am Main, 60594, Germany|Research Site, Frankfurt, 60594, Germany|Research Site, Frankfurt, 60596, Germany|Research Site, Freiburg im Breisgau, 79106, Germany|Research Site, Freiburg, 79110, Germany|Research Site, Freudenstadt, 72250, Germany|Research Site, Gelnhausen, 63571, Germany|Research Site, Giengen, 89537, Germany|Research Site, Goch, 47574, Germany|Research Site, Grevesmühlen, 23936, Germany|Research Site, Grossheirath, 96269, Germany|Research Site, Göttingen, 37073, Germany|Research Site, Hamburg, 20246, Germany|Research Site, Hamburg, 21073, Germany|Research Site, Hamburg, 21109, Germany|Research Site, Hamburg, 22041, Germany|Research Site, Hamburg, 22391, Germany|Research Site, Hamburg, 22607, Germany|Research Site, Hameln, 31785, Germany|Research Site, Hannover, 30625, Germany|Research Site, Heidelberg, 69115, Germany|Research Site, Herne, 44653, Germany|Research Site, Hildesheim, 31139, Germany|Research Site, Hof, 95030, Germany|Research Site, Hohenmölsen, 06679, Germany|Research Site, Höhenkirchen, 85635, Germany|Research Site, Jerichow, 39319, Germany|Research Site, Kallstadt, 67169, Germany|Research Site, Karlsruhe, 76199, Germany|Research Site, Kassel, 34117, Germany|Research Site, Kiel-Kronshagen, 24119, Germany|Research Site, Köln, 51069, Germany|Research Site, Köthen, 06366, Germany|Research Site, Leipzig, 04103, Germany|Research Site, Leipzig, 04109, Germany|Research Site, Lichtenfels, 96215, Germany|Research Site, Lingen, 49808, Germany|Research Site, Ludwigshafen, 67059, Germany|Research Site, Löhne, 32584, Germany|Research Site, Magdeburg, 39120, Germany|Research Site, Mannheim, 68161, Germany|Research Site, Mannheim, 68163, Germany|Research Site, Marburg, 35037, Germany|Research Site, Marl, 45770, Germany|Research Site, Meine, 38527, Germany|Research Site, Meißen, 01662, Germany|Research Site, Mühldorf A. Inn, 84453, Germany|Research Site, München, 80339, Germany|Research Site, München, 80809, Germany|Research Site, München, 81477, Germany|Research Site, Münster, 48143, Germany|Research Site, Münster, 48153, Germany|Research Site, Neumünster, 24534, Germany|Research Site, Neuwied Am Rhein, 56564, Germany|Research Site, Oldenburg, 23758, Germany|Research Site, Papenburg, 26871, Germany|Research Site, Pirna, 01796, Germany|Research Site, Rehburg Loccum, 31547, Germany|Research Site, Rehlingen Siersburg, 66780, Germany|Research Site, Reinfeld, 23858, Germany|Research Site, Remagen, 53424, Germany|Research Site, Rhaunen, 55624, Germany|Research Site, Rodgau-Dudenhofen, 63110, Germany|Research Site, Saarlouis, 66740, Germany|Research Site, Schwabenheim, 55270, Germany|Research Site, Speyer, 67346, Germany|Research Site, Stadtbergen, 86391, Germany|Research Site, Stolberg, 52222, Germany|Research Site, Straubing, 94315, Germany|Research Site, Stuttgart, 70199, Germany|Research Site, Sulzbach, 92237, Germany|Research Site, Trier, 54290, Germany|Research Site, Villingen-Schwenningen, 78048, Germany|Research Site, Wahlstedt, 23812, Germany|Research Site, Wangen, 88239, Germany|Research Site, Weinheim, 69469, Germany|Research Site, Westerkappeln, 49492, Germany|Research Site, Wetzlar, 35584, Germany|Research Site, Witten, 58455, Germany|Research Site, Budapest, 1106, Hungary|Research Site, Budapest, 1171, Hungary|Research Site, Budapest, 1213, Hungary|Research Site, Csongrád, 6640, Hungary|Research Site, Debrecen, 4025, Hungary|Research Site, Esztergom, 2500, Hungary|Research Site, Hatvan, 3000, Hungary|Research Site, Kisvárda, 4600, Hungary|Research Site, Komárom, 2921, Hungary|Research Site, Miskolc, 3529, Hungary|Research Site, Mosonmagyaróvár, 9200, Hungary|Research Site, Nyíregyháza, 4405, Hungary|Research Site, Orosháza-Szentetornya, 5900, Hungary|Research Site, Polgár, 4090, Hungary|Research Site, Pécs, 7623, Hungary|Research Site, Székesfehérvár, 8000, Hungary|Research Site, Ács, 2941, Hungary|Research Site, Bochnia, 32-700, Poland|Research Site, Bydgoszcz, 85-231, Poland|Research Site, Chrzanow, 32-500, Poland|Research Site, Gdańsk, 80-286, Poland|Research Site, Koluszki, 95-040, Poland|Research Site, Krakow, 31-567, Poland|Research Site, Legnica, 59-220, Poland|Research Site, Mrągowo, 11-700, Poland|Research Site, Ostrowiec Świętokrzyski, 27-400, Poland|Research Site, Poznan, 61655, Poland|Research Site, Sobótka, 55-050, Poland|Research Site, Wierzchosławice, 33-122, Poland|Research Site, Wrocław, 54-144, Poland|Research Site, Łódź, 90-132, Poland|Research Site, Banska Bystrica, 974 01, Slovakia|Research Site, Bratislava, 81108, Slovakia|Research Site, Bratislava, 833 01, Slovakia|Research Site, Kosice, 040 01, Slovakia|Research Site, Kosice, 04011, Slovakia|Research Site, Kosice, Slovakia|Research Site, Levice, 934 01, Slovakia|Research Site, Levice, 934 05, Slovakia|Research Site, Lucenec, 984 01, Slovakia|Research Site, Malacky, 901 01, Slovakia|Research Site, Namestovo, 029 01, Slovakia|Research Site, Nove Zamky, 94001, Slovakia|Research Site, Povazska Bystrica, 017 01, Slovakia|Research Site, Povazska Bystrica, 017 26, Slovakia|Research Site, Prievidza, 971 01, Slovakia|Research Site, Puchov, 020 01, Slovakia|Research Site, Rimavska Sobota, 979 01, Slovakia|Research Site, Sabinov, 083 01, Slovakia|Research Site, Trencin, 911 01, Slovakia|Research Site, Trnava, 917 01, Slovakia|Research Site, Vrutky, 038 61, Slovakia
URL: https://clinicaltrials.gov/show/NCT02471404

Drug ID Drug Name Type DrugBank ID Targets Category Latest Progress
D445 Dapagliflozin small molecule DB06292 Details
D184 Simvastatin small molecule DB00641 Details
D447 Saxagliptin small molecule DB06335 Details