Efficacy and Safety of Dapagliflozin and Dapagliflozin Plus Saxagliptin in Combination With Metformin in Type 2 Diabetes Patients Compared With Sulphonylurea
NCT ID: NCT02471404
Last Updated: 2019-03-26
Study Results
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View full resultsBasic Information
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COMPLETED
PHASE4
939 participants
INTERVENTIONAL
2015-09-21
2017-03-13
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
TRIPLE
Study Groups
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Dapagliflozin+metformin
Dapagliflozin + saxagliptin placebo + glimepiride placebo + metformin
Dapagliflozin
10 mg, orally Green, plain, diamond-shaped, film-coated tablet
Placebo for saxagliptin
Does not contain active ingredient, orally Plain, yellow, biconvex, round, film-coated tablet
Placebo for glimepiride
Does not contain active ingredient, orally. Opaque gray capsule
Dapagliflozin+saxagliptin+metformin
Dapagliflozin + saxagliptin + glimepiride placebo+ metformin
Dapagliflozin
10 mg, orally Green, plain, diamond-shaped, film-coated tablet
Saxagliptin
5 mg, orally Plain, yellow, biconvex, round, film-coated tablet
Placebo for glimepiride
Does not contain active ingredient, orally. Opaque gray capsule
Glimepiride+metformin
Glimepiride + dapagliflozin placebo + saxagliptin placebo + metformin
Glimepiride
1, 2, or 4 mg, orally Opaque gray capsule
Placebo for dapagliflozin
Does not contain active ingredient, orally Green, plain, diamond-shaped, film-coated tablet
Placebo for saxagliptin
Does not contain active ingredient, orally Plain, yellow, biconvex, round, film-coated tablet
Interventions
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Dapagliflozin
10 mg, orally Green, plain, diamond-shaped, film-coated tablet
Saxagliptin
5 mg, orally Plain, yellow, biconvex, round, film-coated tablet
Glimepiride
1, 2, or 4 mg, orally Opaque gray capsule
Placebo for dapagliflozin
Does not contain active ingredient, orally Green, plain, diamond-shaped, film-coated tablet
Placebo for saxagliptin
Does not contain active ingredient, orally Plain, yellow, biconvex, round, film-coated tablet
Placebo for glimepiride
Does not contain active ingredient, orally. Opaque gray capsule
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
2. Has a HbA1c of ≥7.5% and ≤10.5% based on central laboratory results from Visit 1, with individual need for therapy escalation.
3. Currently treated with a stable maximum tolarated dose (MTD) (≥1500 mg/day) of metformin therapy for at least 8 weeks prior to Enrolment visit.
4. Has a BMI of ≤45 kg/m2 at Enrolment visit.
5. Has a C-peptide laboratory value of ≥1.0 ng/mL (0.33 nmol/L; 333.3 pmol/L) based on central laboratory results from Visit 1.
Exclusion Criteria
2. Patients who, in the judgment of the Investigator, may be at risk for dehydration or volume depletion that may affect the patient's safety and/or the interpretation of efficacy or safety data.
3. Clinically significant cardiovascular disease or procedure within 3 months prior to Enrolment or expected to require coronary revascularization procedure during the course of the study.
4. Concomitant treatment with loop diuretics
18 Years
74 Years
ALL
No
Sponsors
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AstraZeneca
INDUSTRY
Responsible Party
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Locations
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Research Site
Hodonín, , Czechia
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Hradec Králové, , Czechia
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Jílové u Prahy, , Czechia
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Ostrava - Belsky Les, , Czechia
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Pardubice, , Czechia
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Plzen - Severni Predmesti, , Czechia
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Praha Klanovice, , Czechia
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Přelouč, , Czechia
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Uherské Hradiště, , Czechia
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Zlín, , Czechia
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Aschaffenburg, , Germany
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Bad Homburg, , Germany
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Bad Mergentheim, , Germany
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Bad Nauheim, , Germany
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Bad Neuenahr-Ahrweiler, , Germany
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Bad Oeynhausen, , Germany
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Bad Reichenhall, , Germany
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Berlin, , Germany
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Berlin, , Germany
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Berlin, , Germany
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Berlin, , Germany
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Berlin, , Germany
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Berlin, , Germany
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Berlin, , Germany
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Bochum, , Germany
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Bochum, , Germany
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Bonn, , Germany
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Bünde, , Germany
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Cologne, , Germany
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Daaden, , Germany
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Darmstadt, , Germany
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Datteln, , Germany
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Deggingen, , Germany
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Dippoldiswalde, , Germany
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Dortmund, , Germany
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Dresden, , Germany
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Duisburg, , Germany
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Erfurt, , Germany
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Erlangen, , Germany
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Eschweiler, , Germany
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Essen, , Germany
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Essen, , Germany
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Essen, , Germany
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Frankfurt, , Germany
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Frankfurt, , Germany
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Frankfurt am Main, , Germany
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Freiburg im Breisgau, , Germany
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Freiburg im Breisgau, , Germany
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Freudenstadt, , Germany
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Gelnhausen, , Germany
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Giengen an der Brenz, , Germany
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Goch, , Germany
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Göttingen, , Germany
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Grevesmühlen, , Germany
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Großheirath, , Germany
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Hamburg, , Germany
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Hamburg, , Germany
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Hamburg, , Germany
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Hamburg, , Germany
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Hamburg, , Germany
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Hamburg, , Germany
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Hamelin, , Germany
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Hanover, , Germany
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Heidelberg, , Germany
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Herne, , Germany
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Hildesheim, , Germany
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Hof, , Germany
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Hohenmölsen, , Germany
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Höhenkirchen, , Germany
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Jerichow, , Germany
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Kallstadt, , Germany
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Karlsruhe, , Germany
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Kassel, , Germany
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Kiel-Kronshagen, , Germany
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Köthen, , Germany
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Leipzig, , Germany
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Leipzig, , Germany
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Lichtenfels, , Germany
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Lingen, , Germany
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Löhne, , Germany
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Ludwigshafen, , Germany
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Magdeburg, , Germany
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Mannheim, , Germany
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Mannheim, , Germany
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Marburg, , Germany
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Marl, , Germany
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Meine, , Germany
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Meißen, , Germany
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Mühldorf A. Inn, , Germany
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München, , Germany
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München, , Germany
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München, , Germany
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Münster, , Germany
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Münster, , Germany
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Neumünster, , Germany
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Neuwied Am Rhein, , Germany
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Oldenburg, , Germany
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Papenburg, , Germany
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Pirna, , Germany
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Rehburg-Loccum, , Germany
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Rehlingen-Siersburg, , Germany
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Reinfeld, , Germany
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Remagen, , Germany
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Rhaunen, , Germany
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Rodgau-Dudenhofen, , Germany
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Saarlouis, , Germany
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Schwabenheim, , Germany
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Speyer, , Germany
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Stadtbergen, , Germany
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Stolberg, , Germany
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Straubing, , Germany
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Stuttgart, , Germany
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Sulzbach, , Germany
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Trier, , Germany
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Villingen-Schwenningen, , Germany
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Wahlstedt, , Germany
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Wangen, , Germany
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Weinheim, , Germany
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Westerkappeln, , Germany
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Wetzlar, , Germany
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Witten, , Germany
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Ács, , Hungary
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Budapest, , Hungary
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Budapest, , Hungary
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Budapest, , Hungary
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Csongrád, , Hungary
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Debrecen, , Hungary
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Esztergom, , Hungary
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Hatvan, , Hungary
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Kisvárda, , Hungary
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Komárom, , Hungary
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Miskolc, , Hungary
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Mosonmagyaróvár, , Hungary
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Nyíregyháza, , Hungary
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Orosháza-Szentetornya, , Hungary
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Pécs, , Hungary
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Polgár, , Hungary
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Székesfehérvár, , Hungary
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Bochnia, , Poland
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Bydgoszcz, , Poland
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Chrzanów, , Poland
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Gdansk, , Poland
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Koluszki, , Poland
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Krakow, , Poland
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Legnica, , Poland
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Lodz, , Poland
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Mrągowo, , Poland
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Ostrowiec Świętokrzyski, , Poland
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Poznan, , Poland
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Sobótka, , Poland
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Wierzchosławice, , Poland
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Wroclaw, , Poland
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Banská Bystrica, , Slovakia
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Bratislava, , Slovakia
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Bratislava, , Slovakia
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Košice, , Slovakia
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Košice, , Slovakia
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Košice, , Slovakia
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Levice, , Slovakia
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Levice, , Slovakia
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Lučenec, , Slovakia
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Malacky, , Slovakia
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Námestovo, , Slovakia
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Nové Zámky, , Slovakia
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Považská Bystrica, , Slovakia
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Považská Bystrica, , Slovakia
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Prievidza, , Slovakia
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Púchov, , Slovakia
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Rimavská Sobota, , Slovakia
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Sabinov, , Slovakia
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Trenčín, , Slovakia
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Trnava, , Slovakia
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Vrútky, , Slovakia
Countries
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References
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Muller-Wieland D, Kellerer M, Cypryk K, Skripova D, Rohwedder K, Johnsson E, Garcia-Sanchez R, Kurlyandskaya R, Sjostrom CD, Jacob S, Seufert J, Dronamraju N, Csomos K. Efficacy and safety of dapagliflozin or dapagliflozin plus saxagliptin versus glimepiride as add-on to metformin in patients with type 2 diabetes. Diabetes Obes Metab. 2018 Nov;20(11):2598-2607. doi: 10.1111/dom.13437. Epub 2018 Jul 16.
Provided Documents
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Document Type: Statistical Analysis Plan
Document Type: Study Protocol
Related Links
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Other Identifiers
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D1689C00014
Identifier Type: -
Identifier Source: org_study_id
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