Saxagliptin Compared to Glimepiride in Elderly Type 2 Diabetes Patients, With Inadequate Glycemic Control on Metformin
GENERATION
A 52-Week, Randomised, Double Blind, Active-Controlled, Multi-Centre Phase IIIb/IV Study to Evaluate the Efficacy and Tolerability of Saxagliptin Compared to Glimepiride in Elderly Patients With Type 2 Diabetes Mellitus Who Have Inadequate Glycaemic Control on Metformin Monotherapy
1 other identifier
interventional
957
13 countries
131
Brief Summary
This study will evaluate the efficacy and tolerability of saxagliptin compared to glimepiride in elderly patients with type 2 diabetes mellitus who have inadequate glycaemic control on metformin monotherapy.
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 Oct 2009
Typical duration for phase_4 type-2-diabetes-mellitus
131 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
Study Start
First participant enrolled
October 1, 2009
CompletedFirst Submitted
Initial submission to the registry
October 31, 2009
CompletedFirst Posted
Study publicly available on registry
November 3, 2009
CompletedPrimary Completion
Last participant's last visit for primary outcome
June 1, 2012
CompletedStudy Completion
Last participant's last visit for all outcomes
June 1, 2012
CompletedResults Posted
Study results publicly available
November 28, 2013
CompletedNovember 28, 2013
September 1, 2013
2.7 years
October 31, 2009
June 12, 2013
September 27, 2013
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Proportion of Patients Reaching HbA1c <7% After 52 Weeks of Treatment Without Confirmed or Severe Hypoglycaemia.
Defined as obtained on or before the 8th day after the last dosing day, as determined by central laboratory. Safety analysis set. Confirmed hypoglycaemia defined as: any event defined as either a symptomatic event with blood glucose level \<3 mmol/L (\<54 mg/dL) and no need for external assistance, or an asymptomatic blood glucose measurement \<3 mmol/L (\<54 mg/dL). Major (or severe) hypoglycaemia defined as: symptomatic events requiring external assistance due to severe impairment in consciousness or behaviour, with or without blood glucose level \<3 mmol/L (\<54 mg/dL), but with prompt recovery after glucose or glucagon administration. These events may be associated with sufficient neuroglycopenia to induce seizure or coma. Plasma glucose measurements may not be available during such an event, but neurological recovery, attributable to the restoration of plasma glucose to normal, was considered sufficient evidence that the event was induced by a low plasma glucose concentration.
From week 0 to week 52.
Secondary Outcomes (6)
Proportion of Patients Having Experienced at Least One Hypoglycaemic Event (Confirmed or Severe) Over the 52-week Double-blind Treatment Period.
From week 0 to week 52.
Change From Baseline to Week 52 in HbA1c.
From week 0 to week 52.
Proportion of Patients Achieving a Therapeutic Glycaemic Response at Week 52 Defined as HbA1c <7.0%
From week 0 to week 52
Change From Baseline to Week 52 in Fasting Plasma Glucose (FPG)
From week 0 to week 52
Change From Baseline to Week 52 in Insulin
From week 0 to week 52
- +1 more secondary outcomes
Study Arms (2)
1
EXPERIMENTALSaxagliptin 5 mg
2
ACTIVE COMPARATORGlimepiride 1 - 6 mg
Interventions
Eligibility Criteria
You may qualify if:
- Provision of informed consent prior to any study specific procedures
- 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%
You may not qualify if:
- Type 1 diabetes, history of diabetic ketoacidosis or hyperosmolar non-ketonic coma. Current use of any injectable or oral antihyperglycemic agent excluding metformin.
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- AstraZenecalead
- Bristol-Myers Squibbcollaborator
Study Sites (131)
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, 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
Related Publications (2)
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.
PMID: 27823868DERIVEDSchernthaner 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.
PMID: 25761977DERIVED
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Results Point of Contact
- Title
- Boaz Hirshberg , MSD
- Organization
- AstraZeneca
Publication Agreements
- PI is Sponsor Employee
- No
- Restriction Type
- OTHER
- Restrictive Agreement
- Yes
Study Design
- Study Type
- interventional
- Phase
- phase 4
- Allocation
- RANDOMIZED
- Masking
- DOUBLE
- Who Masked
- PARTICIPANT, INVESTIGATOR
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
October 31, 2009
First Posted
November 3, 2009
Study Start
October 1, 2009
Primary Completion
June 1, 2012
Study Completion
June 1, 2012
Last Updated
November 28, 2013
Results First Posted
November 28, 2013
Record last verified: 2013-09