Saxagliptin Compared to Glimepiride in Elderly Type 2 Diabetes Patients, With Inadequate Glycemic Control on Metformin
NCT ID: NCT01006603
Last Updated: 2013-11-28
Study Results
Outcome measurements, participant flow, baseline characteristics, and adverse events have been published for this study.
View full resultsBasic Information
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COMPLETED
PHASE4
957 participants
INTERVENTIONAL
2009-10-31
2012-06-30
Brief Summary
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Detailed Description
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Conditions
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Keywords
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
DOUBLE
Study Groups
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1
Saxagliptin 5 mg
Saxagliptin
5 mg, oral tablet, once daily
2
Glimepiride 1 - 6 mg
Glimepiride
1, 2, 3, 4 or 6 mg, oral encapsulated tablet, once daily
Interventions
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Saxagliptin
5 mg, oral tablet, once daily
Glimepiride
1, 2, 3, 4 or 6 mg, oral encapsulated tablet, once daily
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* Established clinical diagnosis of type 2 diabetes. Treatment with a stable metformin monotherapy, for at least 8 weeks prior to Visit 1
* HbA1c ≥7.0% and ≤9.0%
Exclusion Criteria
* Renal impairment as defined by a creatinine clearance \<60 mL/min
* Individuals who, in the opinion of the investigator, in which participation in this study may pose a significant risk to the patient and could render the patient unable to successfully complete the study
65 Years
ALL
No
Sponsors
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Bristol-Myers Squibb
INDUSTRY
AstraZeneca
INDUSTRY
Responsible Party
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Locations
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Research Site
Feldbach, , Austria
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Graz, , Austria
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Salzburg, , Austria
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Vienna, , Austria
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Aalborg, , Denmark
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Ans, , Denmark
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Kjellerup, , Denmark
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Kolding, , Denmark
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Nørresundby, , Denmark
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Roskilde, , Denmark
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Roslev, , Denmark
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Viborg, , Denmark
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Viby J, , Denmark
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Værløse, , Denmark
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Lahti, Finland, Finland
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Vantaa, Finland, Finland
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Harjavalta, , Finland
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Helsinki, , Finland
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Kuopio, , Finland
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Kuusankoski, , Finland
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Oulu, , Finland
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Seinäjoki, , Finland
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Sipoo, , Finland
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Tampere, , Finland
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Turku, , Finland
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Vimpeli, , Finland
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Châtellerault, , France
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La Rochelle, , France
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La Seyne-sur-Mer, , France
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Laval, , France
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Seysses, , France
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Strasbourg, , France
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Tiercé, , France
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Hamburg, City state of Hamburg, Germany
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Augsburg, , Germany
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Darmstadt, , Germany
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Dresden, , Germany
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Essen, , Germany
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Gelnhausen, , Germany
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Hamburg, , Germany
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Magdeburg, , Germany
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Mayen, , Germany
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München, , Germany
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Neumünster, , Germany
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Nuremberg, , Germany
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Pirna, , Germany
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Ratzeburg, , Germany
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Reinfeld, , Germany
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Sulzbach, , Germany
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Athens, Greece, Greece
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Athens, , Greece
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Nikaia, , Greece
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Thessaloniki, , Greece
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Ács, , Hungary
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Balatonfüred, , Hungary
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Budapest, , Hungary
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Érd, , Hungary
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Gyöngyös, , Hungary
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Komárom, , Hungary
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Milan, MI, Italy
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Palermo, PA, Italy
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Padua, PD, Italy
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Pordenone, PN, Italy
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Reggio Emilia, RE, Italy
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Chieti, , Italy
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Napoli, , Italy
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Roma, , Italy
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Viterbo, , Italy
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Durango, Durango, Mexico
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Guadalajara, Jalisco, Mexico
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Monterrey, Nuevo León, Mexico
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Aksdal, , Norway
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Ålesund, , Norway
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Elverum, , Norway
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Halden, , Norway
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Hamar, , Norway
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Kirkenær, , Norway
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Kongsvinger, , Norway
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Larvik, , Norway
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Lierskogen, , Norway
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Nordlenangen, , Norway
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Oslo, , Norway
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Røa, , Norway
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Sandvika, , Norway
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Skedsmokorset, , Norway
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Svelvik, , Norway
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Sørumsand, , Norway
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Trondheim, , Norway
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Ulset, , Norway
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Seville, Andalusia, Spain
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Zamora, Castille and León, Spain
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A Coruña, Galicia, Spain
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Begonte (lugo), Galicia, Spain
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Getafe, Madrid, Spain
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Madrid, Madrid, Spain
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San Sebastián de los Reyes, Madrid, Spain
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Oviedo, Principality of Asturias, Spain
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Alicante, Valencia, Spain
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Jönköping, Sweden, Sweden
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Finspång, , Sweden
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Gävle, , Sweden
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Gothenburg, , Sweden
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Jarfalla, , Sweden
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Lessebo, , Sweden
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Lund, , Sweden
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Ödeshög, , Sweden
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Piteå, , Sweden
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Rättvik, , Sweden
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Stockholm, , Sweden
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Trollhättan, , Sweden
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Västervik, , Sweden
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Fowey, Cornwall, United Kingdom
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Nr Penzance, Cornwall, United Kingdom
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Penzance, Cornwall, United Kingdom
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Barnstaple, Devon, United Kingdom
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Plymouth, Devon, United Kingdom
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Annan, Dumfries and Galloway, United Kingdom
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Canterbury, Kent, United Kingdom
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Whitstable, Kent, United Kingdom
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Frome, Somerset, United Kingdom
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Bradford-on-Avon, Wiltshire, United Kingdom
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Trowbridge, Wiltshire, United Kingdom
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Ayrshire, , United Kingdom
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Bath, , United Kingdom
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Cumbernauld, , United Kingdom
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Dundee, , United Kingdom
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Hamilton, , United Kingdom
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Middlesex, , United Kingdom
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Motherwell, , United Kingdom
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Somerset, , United Kingdom
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Wellingborough, , United Kingdom
Countries
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References
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Perl S, Cook W, Wei C, Ohman P, Hirshberg B. Effects of Glimepiride versus Saxagliptin on beta-Cell Function and Hypoglycemia: A Post Hoc Analysis in Older Patients with Type 2 Diabetes Inadequately Controlled with Metformin. Clin Ther. 2016 Dec;38(12):2578-2588. doi: 10.1016/j.clinthera.2016.10.006. Epub 2016 Nov 4.
Schernthaner G, Duran-Garcia S, Hanefeld M, Langslet G, Niskanen L, Ostgren CJ, Malvolti E, Hardy E. Efficacy and tolerability of saxagliptin compared with glimepiride in elderly patients with type 2 diabetes: a randomized, controlled study (GENERATION). Diabetes Obes Metab. 2015 Jul;17(7):630-8. doi: 10.1111/dom.12461. Epub 2015 Apr 7.
Other Identifiers
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D1680L00002
Identifier Type: -
Identifier Source: org_study_id