Clinical trial NCT02471404: Efficacy and Safety of Dapagliflozin and Dapagliflozin Plus Saxagliptin in Combination With Metformin in Type 2 Diabetes Patients Compared With Sulphonylurea
Official title: 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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Type 2 Diabetes Mellitus
Inadequate Glycaemic Control
Keywords: Diabetes Mellitus Type 2,
metformin,
saxagliptin,
dapagliflozin,
glimepiride,
inadequate glycaemic control
Lead sponsor: AstraZeneca
Sponsor class: INDUSTRY
First posted: 2015-06-15
Enrollment: 939
Sex: ALL
Minimum age (years): 18
Maximum age (years): 74
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.


Eligibility criteria: Inclusion Criteria: Main Inclusion Criteria:

1. Is male or female and ≥18 and \<75 years old at time of informed consent.
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.

Main, Exclusion Criteria:

1. 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.
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

Primary outcomes:
measure: Change in Haemoglobin A1c (HbA1c) From Baseline to Week 52
timeFrame: 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:
measure: Patients With at Least One Episode of Confirmed Hypoglycaemia
timeFrame: 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
measure: Change in Total Body Weight From Baseline at Week 52
timeFrame: Baseline, week 52. Values recorded after rescue treatment or collected more than 8 days after the last dose date were excluded from the analysis
measure: Change in Fasting Plasma Glucose (FPG) From Baseline to Week 52
timeFrame: Baseline, week 52. Values recorded after rescue treatment or collected more than 8 days after the last dose date were excluded from the analysis
measure: Time to Rescue
timeFrame: Over the 52 week treatment period
measure: Number of Patients Rescued
timeFrame: Over the 52 week treatment period
Other outcomes:
Locations:
city: Hodonin
country: Czechia
facility: Research Site
city: Hradec Kralove
country: Czechia
facility: Research Site
city: Jilove u Prahy
country: Czechia
facility: Research Site
city: Ostrava - Belsky les
country: Czechia
facility: Research Site
city: Pardubice
country: Czechia
facility: Research Site
city: Plzen - Severni Predmesti
country: Czechia
facility: Research Site
city: Praha - Klanovice
country: Czechia
facility: Research Site
city: Prelouc
country: Czechia
facility: Research Site
city: Uherske Hradiste
country: Czechia
facility: Research Site
city: Zlin
country: Czechia
facility: Research Site
city: Aschaffenburg
country: Germany
facility: Research Site
city: Bad Homburg
country: Germany
facility: Research Site
city: Bad Mergentheim
country: Germany
facility: Research Site
city: Bad Nauheim
country: Germany
facility: Research Site
city: Bad Neuenahr-Ahrweiler
country: Germany
facility: Research Site
city: Bad Oeynhausen
country: Germany
facility: Research Site
city: Bad Reichenhall
country: Germany
facility: Research Site
city: Berlin
country: Germany
facility: Research Site
city: Berlin
country: Germany
facility: Research Site
city: Berlin
country: Germany
facility: Research Site
city: Berlin
country: Germany
facility: Research Site
city: Berlin
country: Germany
facility: Research Site
city: Berlin
country: Germany
facility: Research Site
city: Berlin
country: Germany
facility: Research Site
city: Bochum
country: Germany
facility: Research Site
city: Bochum
country: Germany
facility: Research Site
city: Bonn
country: Germany
facility: Research Site
city: Bünde
country: Germany
facility: Research Site
city: Daaden
country: Germany
facility: Research Site
city: Darmstadt
country: Germany
facility: Research Site
city: Datteln
country: Germany
facility: Research Site
city: Deggingen
country: Germany
facility: Research Site
city: Dippoldiswalde
country: Germany
facility: Research Site
city: Dortmund
country: Germany
facility: Research Site
city: Dresden
country: Germany
facility: Research Site
city: Duisburg
country: Germany
facility: Research Site
city: Erfurt
country: Germany
facility: Research Site
city: Erlangen
country: Germany
facility: Research Site
city: Eschweiler
country: Germany
facility: Research Site
city: Essen
country: Germany
facility: Research Site
city: Essen
country: Germany
facility: Research Site
city: Essen
country: Germany
facility: Research Site
city: Frankfurt am Main
country: Germany
facility: Research Site
city: Frankfurt
country: Germany
facility: Research Site
city: Frankfurt
country: Germany
facility: Research Site
city: Freiburg im Breisgau
country: Germany
facility: Research Site
city: Freiburg
country: Germany
facility: Research Site
city: Freudenstadt
country: Germany
facility: Research Site
city: Gelnhausen
country: Germany
facility: Research Site
city: Giengen
country: Germany
facility: Research Site
city: Goch
country: Germany
facility: Research Site
city: Grevesmühlen
country: Germany
facility: Research Site
city: Grossheirath
country: Germany
facility: Research Site
city: Göttingen
country: Germany
facility: Research Site
city: Hamburg
country: Germany
facility: Research Site
city: Hamburg
country: Germany
facility: Research Site
city: Hamburg
country: Germany
facility: Research Site
city: Hamburg
country: Germany
facility: Research Site
city: Hamburg
country: Germany
facility: Research Site
city: Hamburg
country: Germany
facility: Research Site
city: Hameln
country: Germany
facility: Research Site
city: Hannover
country: Germany
facility: Research Site
city: Heidelberg
country: Germany
facility: Research Site
city: Herne
country: Germany
facility: Research Site
city: Hildesheim
country: Germany
facility: Research Site
city: Hof
country: Germany
facility: Research Site
city: Hohenmölsen
country: Germany
facility: Research Site
city: Höhenkirchen
country: Germany
facility: Research Site
city: Jerichow
country: Germany
facility: Research Site
city: Kallstadt
country: Germany
facility: Research Site
city: Karlsruhe
country: Germany
facility: Research Site
city: Kassel
country: Germany
facility: Research Site
city: Kiel-Kronshagen
country: Germany
facility: Research Site
city: Köln
country: Germany
facility: Research Site
city: Köthen
country: Germany
facility: Research Site
city: Leipzig
country: Germany
facility: Research Site
city: Leipzig
country: Germany
facility: Research Site
city: Lichtenfels
country: Germany
facility: Research Site
city: Lingen
country: Germany
facility: Research Site
city: Ludwigshafen
country: Germany
facility: Research Site
city: Löhne
country: Germany
facility: Research Site
city: Magdeburg
country: Germany
facility: Research Site
city: Mannheim
country: Germany
facility: Research Site
city: Mannheim
country: Germany
facility: Research Site
city: Marburg
country: Germany
facility: Research Site
city: Marl
country: Germany
facility: Research Site
city: Meine
country: Germany
facility: Research Site
city: Meißen
country: Germany
facility: Research Site
city: Mühldorf A. Inn
country: Germany
facility: Research Site
city: München
country: Germany
facility: Research Site
city: München
country: Germany
facility: Research Site
city: München
country: Germany
facility: Research Site
city: Münster
country: Germany
facility: Research Site
city: Münster
country: Germany
facility: Research Site
city: Neumünster
country: Germany
facility: Research Site
city: Neuwied Am Rhein
country: Germany
facility: Research Site
city: Oldenburg
country: Germany
facility: Research Site
city: Papenburg
country: Germany
facility: Research Site
city: Pirna
country: Germany
facility: Research Site
city: Rehburg Loccum
country: Germany
facility: Research Site
city: Rehlingen Siersburg
country: Germany
facility: Research Site
city: Reinfeld
country: Germany
facility: Research Site
city: Remagen
country: Germany
facility: Research Site
city: Rhaunen
country: Germany
facility: Research Site
city: Rodgau-Dudenhofen
country: Germany
facility: Research Site
city: Saarlouis
country: Germany
facility: Research Site
city: Schwabenheim
country: Germany
facility: Research Site
city: Speyer
country: Germany
facility: Research Site
city: Stadtbergen
country: Germany
facility: Research Site
city: Stolberg
country: Germany
facility: Research Site
city: Straubing
country: Germany
facility: Research Site
city: Stuttgart
country: Germany
facility: Research Site
city: Sulzbach
country: Germany
facility: Research Site
city: Trier
country: Germany
facility: Research Site
city: Villingen-Schwenningen
country: Germany
facility: Research Site
city: Wahlstedt
country: Germany
facility: Research Site
city: Wangen
country: Germany
facility: Research Site
city: Weinheim
country: Germany
facility: Research Site
city: Westerkappeln
country: Germany
facility: Research Site
city: Wetzlar
country: Germany
facility: Research Site
city: Witten
country: Germany
facility: Research Site
city: Budapest
country: Hungary
facility: Research Site
city: Budapest
country: Hungary
facility: Research Site
city: Budapest
country: Hungary
facility: Research Site
city: Csongrád
country: Hungary
facility: Research Site
city: Debrecen
country: Hungary
facility: Research Site
city: Esztergom
country: Hungary
facility: Research Site
city: Hatvan
country: Hungary
facility: Research Site
city: Kisvárda
country: Hungary
facility: Research Site
city: Komárom
country: Hungary
facility: Research Site
city: Miskolc
country: Hungary
facility: Research Site
city: Mosonmagyaróvár
country: Hungary
facility: Research Site
city: Nyíregyháza
country: Hungary
facility: Research Site
city: Orosháza-Szentetornya
country: Hungary
facility: Research Site
city: Polgár
country: Hungary
facility: Research Site
city: Pécs
country: Hungary
facility: Research Site
city: Székesfehérvár
country: Hungary
facility: Research Site
city: Ács
country: Hungary
facility: Research Site
city: Bochnia
country: Poland
facility: Research Site
city: Bydgoszcz
country: Poland
facility: Research Site
city: Chrzanow
country: Poland
facility: Research Site
city: Gdańsk
country: Poland
facility: Research Site
city: Koluszki
country: Poland
facility: Research Site
city: Krakow
country: Poland
facility: Research Site
city: Legnica
country: Poland
facility: Research Site
city: Mrągowo
country: Poland
facility: Research Site
city: Ostrowiec Świętokrzyski
country: Poland
facility: Research Site
city: Poznan
country: Poland
facility: Research Site
city: Sobótka
country: Poland
facility: Research Site
city: Wierzchosławice
country: Poland
facility: Research Site
city: Wrocław
country: Poland
facility: Research Site
city: Łódź
country: Poland
facility: Research Site
city: Banska Bystrica
country: Slovakia
facility: Research Site
city: Bratislava
country: Slovakia
facility: Research Site
city: Bratislava
country: Slovakia
facility: Research Site
city: Kosice
country: Slovakia
facility: Research Site
city: Kosice
country: Slovakia
facility: Research Site
city: Kosice
country: Slovakia
facility: Research Site
city: Levice
country: Slovakia
facility: Research Site
city: Levice
country: Slovakia
facility: Research Site
city: Lucenec
country: Slovakia
facility: Research Site
city: Malacky
country: Slovakia
facility: Research Site
city: Namestovo
country: Slovakia
facility: Research Site
city: Nove Zamky
country: Slovakia
facility: Research Site
city: Povazska Bystrica
country: Slovakia
facility: Research Site
city: Povazska Bystrica
country: Slovakia
facility: Research Site
city: Prievidza
country: Slovakia
facility: Research Site
city: Puchov
country: Slovakia
facility: Research Site
city: Rimavska Sobota
country: Slovakia
facility: Research Site
city: Sabinov
country: Slovakia
facility: Research Site
city: Trencin
country: Slovakia
facility: Research Site
city: Trnava
country: Slovakia
facility: Research Site
city: Vrutky
country: Slovakia
facility: Research Site
Study officials:
References:
citation: 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.