Efficacy and Safety of Dapagliflozin and Dapagliflozin Plus Saxagliptin in Combination With Metformin in Type 2 Diabetes Patients Compared With Sulphonylurea
A 52-Week, Multi-Centre, Randomised, Parallel-Group, Double-Blind, Active Controlled, Phase IV Study to Evaluate the Safety and Efficacy of Dapagliflozin or Dapagliflozin Plus Saxagliptin Compared With Sulphonylurea All Given as Add-on Therapy to Metformin in Adult Patients With Type 2 Diabetes Who Have Inadequate Glycaemic Control on Metformin Monotherapy
1 other identifier
interventional
939
5 countries
173
Brief Summary
This study is being carried out to see if dapagliflozin and dapagliflozin plus saxagliptin as an addition to metformin is effective and safe in treating patients with type 2 diabetes when compared to glimepiride (sulphonylurea) as an addition to metformin treatment.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for phase_4 type-2-diabetes-mellitus
Started Sep 2015
173 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
First Submitted
Initial submission to the registry
June 11, 2015
CompletedFirst Posted
Study publicly available on registry
June 15, 2015
CompletedStudy Start
First participant enrolled
September 21, 2015
CompletedPrimary Completion
Last participant's last visit for primary outcome
March 13, 2017
CompletedStudy Completion
Last participant's last visit for all outcomes
March 13, 2017
CompletedResults Posted
Study results publicly available
March 26, 2019
CompletedMarch 26, 2019
March 1, 2019
1.5 years
June 11, 2015
March 13, 2018
March 22, 2019
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
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 Outcomes (5)
Patients With at Least One Episode of Confirmed Hypoglycaemia
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
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
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
Over the 52 week treatment period
Number of Patients Rescued
Over the 52 week treatment period
Study Arms (3)
Dapagliflozin+metformin
ACTIVE COMPARATORDapagliflozin + saxagliptin placebo + glimepiride placebo + metformin
Dapagliflozin+saxagliptin+metformin
ACTIVE COMPARATORDapagliflozin + saxagliptin + glimepiride placebo+ metformin
Glimepiride+metformin
ACTIVE COMPARATORGlimepiride + dapagliflozin placebo + saxagliptin placebo + metformin
Interventions
10 mg, orally Green, plain, diamond-shaped, film-coated tablet
5 mg, orally Plain, yellow, biconvex, round, film-coated tablet
Does not contain active ingredient, orally Green, plain, diamond-shaped, film-coated tablet
Does not contain active ingredient, orally Plain, yellow, biconvex, round, film-coated tablet
Does not contain active ingredient, orally. Opaque gray capsule
Eligibility Criteria
You may qualify if:
- Is male or female and ≥18 and \<75 years old at time of informed consent.
- Has a HbA1c of ≥7.5% and ≤10.5% based on central laboratory results from Visit 1, with individual need for therapy escalation.
- Currently treated with a stable maximum tolarated dose (MTD) (≥1500 mg/day) of metformin therapy for at least 8 weeks prior to Enrolment visit.
- Has a BMI of ≤45 kg/m2 at Enrolment visit.
- 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.
You may not qualify if:
- Clinically diagnosed with Type I diabetes, known diagnosis of maturity onset diabetes of the young (MODY), or secondary diabetes mellitus or known presence of glutamate decarboxylase 65 (GAD65) antibodies.
- 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.
- 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.
- Concomitant treatment with loop diuretics
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- AstraZenecalead
Study Sites (173)
Research Site
Hodonín, 695 01, Czechia
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Hradec Králové, 500 05, Czechia
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Jílové u Prahy, 254 01, Czechia
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Ostrava - Belsky Les, 700 30, Czechia
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Pardubice, 530 02, Czechia
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Plzen - Severni Predmesti, 301 00, Czechia
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Praha Klanovice, 190 14, Czechia
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Přelouč, 535 01, Czechia
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Uherské Hradiště, 686 01, Czechia
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Zlín, 760 01, Czechia
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Aschaffenburg, 63739, Germany
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Bad Homburg, 61348, Germany
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Bad Mergentheim, 97980, Germany
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Bad Nauheim, 61231, Germany
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Bad Neuenahr-Ahrweiler, 53474, Germany
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Bad Oeynhausen, 32545, Germany
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Bad Reichenhall, 83435, Germany
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Berlin, 10115, Germany
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Berlin, 10409, Germany
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Berlin, 10629, Germany
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Berlin, 10787, Germany
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Berlin, 12627, Germany
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Berlin, 13125, Germany
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Berlin, 13597, Germany
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Bochum, 44787, Germany
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Bochum, 44869, Germany
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Bonn, 53179, Germany
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Bünde, 32257, Germany
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Cologne, 51069, Germany
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Daaden, 57567, Germany
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Darmstadt, 64295, Germany
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Datteln, 45711, Germany
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Deggingen, 73326, Germany
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Dippoldiswalde, 01744, Germany
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Dortmund, 44137, Germany
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Dresden, 01309, Germany
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Duisburg, 47179, Germany
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Erfurt, 99085, Germany
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Erlangen, 91052, Germany
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Eschweiler, 52249, Germany
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Essen, 45136, Germany
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Essen, 45355, Germany
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Essen, 45359, Germany
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Frankfurt, 60594, Germany
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Frankfurt, 60596, Germany
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Frankfurt am Main, 60594, Germany
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Freiburg im Breisgau, 79106, Germany
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Freiburg im Breisgau, 79110, Germany
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Freudenstadt, 72250, Germany
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Gelnhausen, 63571, Germany
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Giengen an der Brenz, 89537, Germany
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Goch, 47574, Germany
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Göttingen, 37073, Germany
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Grevesmühlen, 23936, Germany
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Großheirath, 96269, Germany
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Hamburg, 20246, Germany
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Hamburg, 21073, Germany
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Hamburg, 21109, Germany
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Hamburg, 22041, Germany
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Hamburg, 22391, Germany
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Hamburg, 22607, Germany
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Hamelin, 31785, Germany
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Hanover, 30625, Germany
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Heidelberg, 69115, Germany
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Herne, 44653, Germany
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Hildesheim, 31139, Germany
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Hof, 95030, Germany
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Hohenmölsen, 06679, Germany
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Höhenkirchen, 85635, Germany
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Jerichow, 39319, Germany
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Kallstadt, 67169, Germany
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Karlsruhe, 76199, Germany
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Kassel, 34117, Germany
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Kiel-Kronshagen, 24119, Germany
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Köthen, 06366, Germany
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Leipzig, 04103, Germany
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Leipzig, 04109, Germany
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Lichtenfels, 96215, Germany
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Lingen, 49808, Germany
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Löhne, 32584, Germany
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Ludwigshafen, 67059, Germany
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Magdeburg, 39120, Germany
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Mannheim, 68161, Germany
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Mannheim, 68163, Germany
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Marburg, 35037, Germany
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Marl, 45770, Germany
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Meine, 38527, Germany
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Meißen, 01662, Germany
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Mühldorf A. Inn, 84453, Germany
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München, 80339, Germany
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München, 80809, Germany
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München, 81477, Germany
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Münster, 48143, Germany
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Münster, 48153, Germany
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Neumünster, 24534, Germany
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Neuwied Am Rhein, 56564, Germany
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Oldenburg, 23758, Germany
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Papenburg, 26871, Germany
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Pirna, 01796, Germany
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Rehburg-Loccum, 31547, Germany
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Rehlingen-Siersburg, 66780, Germany
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Reinfeld, 23858, Germany
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Remagen, 53424, Germany
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Rhaunen, 55624, Germany
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Rodgau-Dudenhofen, 63110, Germany
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Saarlouis, 66740, Germany
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Schwabenheim, 55270, Germany
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Speyer, 67346, Germany
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Stadtbergen, 86391, Germany
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Stolberg, 52222, Germany
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Straubing, 94315, Germany
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Stuttgart, 70199, Germany
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Sulzbach, 92237, Germany
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Trier, 54290, Germany
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Villingen-Schwenningen, 78048, Germany
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Wahlstedt, 23812, Germany
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Wangen, 88239, Germany
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Weinheim, 69469, Germany
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Westerkappeln, 49492, Germany
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Wetzlar, 35584, Germany
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Witten, 58455, Germany
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Ács, 2941, Hungary
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Budapest, 1106, Hungary
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Budapest, 1171, Hungary
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Budapest, 1213, Hungary
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Csongrád, 6640, Hungary
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Debrecen, 4025, Hungary
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Esztergom, 2500, Hungary
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Hatvan, 3000, Hungary
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Kisvárda, 4600, Hungary
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Komárom, 2921, Hungary
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Miskolc, 3529, Hungary
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Mosonmagyaróvár, 9200, Hungary
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Nyíregyháza, 4405, Hungary
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Orosháza-Szentetornya, 5900, Hungary
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Pécs, 7623, Hungary
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Polgár, 4090, Hungary
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Székesfehérvár, 8000, Hungary
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Bochnia, 32-700, Poland
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Bydgoszcz, 85-231, Poland
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Chrzanów, 32-500, Poland
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Gdansk, 80-286, Poland
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Koluszki, 95-040, Poland
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Krakow, 31-567, Poland
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Legnica, 59-220, Poland
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Lodz, 90-132, Poland
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Mrągowo, 11-700, Poland
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Ostrowiec Świętokrzyski, 27-400, Poland
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Poznan, 61655, Poland
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Sobótka, 55-050, Poland
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Wierzchosławice, 33-122, Poland
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Wroclaw, 54-144, Poland
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Banská Bystrica, 974 01, Slovakia
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Bratislava, 81108, Slovakia
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Bratislava, 833 01, Slovakia
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Košice, 040 01, Slovakia
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Košice, 04011, Slovakia
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Košice, Slovakia
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Levice, 934 01, Slovakia
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Levice, 934 05, Slovakia
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Lučenec, 984 01, Slovakia
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Malacky, 901 01, Slovakia
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Námestovo, 029 01, Slovakia
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Nové Zámky, 94001, Slovakia
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Považská Bystrica, 017 01, Slovakia
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Považská Bystrica, 017 26, Slovakia
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Prievidza, 971 01, Slovakia
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Púchov, 020 01, Slovakia
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Rimavská Sobota, 979 01, Slovakia
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Sabinov, 083 01, Slovakia
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Trenčín, 911 01, Slovakia
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Trnava, 917 01, Slovakia
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Vrútky, 038 61, Slovakia
Related Publications (1)
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.
PMID: 29947099DERIVED
Related Links
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Results Point of Contact
- Title
- Eva Johnsson, MD, PhD
- Organization
- AstraZeneca
Publication Agreements
- PI is Sponsor Employee
- No
- Restrictive Agreement
- No
Study Design
- Study Type
- interventional
- Phase
- phase 4
- Allocation
- RANDOMIZED
- Masking
- TRIPLE
- Who Masked
- PARTICIPANT, CARE PROVIDER, INVESTIGATOR
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
June 11, 2015
First Posted
June 15, 2015
Study Start
September 21, 2015
Primary Completion
March 13, 2017
Study Completion
March 13, 2017
Last Updated
March 26, 2019
Results First Posted
March 26, 2019
Record last verified: 2019-03