Clinical trial NCT01006603: Saxagliptin Compared to Glimepiride in Elderly Type 2 Diabetes Patients, With Inadequate Glycemic Control on Metformin
Official title: 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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Type 2 Diabetes Mellitus
Keywords: Type 2 Diabetes Mellitus
elderly patients
saxagliptin
randomised
double-blind
Lead sponsor: AstraZeneca
Sponsor class: INDUSTRY
Collaborators: name: Bristol-Myers Squibb
First posted: 2009-11-03
Enrollment: 957
Sex: ALL
Minimum age (years): 65
Standard ages: OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.


Eligibility criteria: Inclusion Criteria:

* 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%

Exclusion Criteria:

* 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

Primary outcomes:
measure: Proportion of Patients Reaching HbA1c <7% After 52 Weeks of Treatment Without Confirmed or Severe Hypoglycaemia.
timeFrame: From week 0 to week 52.
Secondary outcomes:
measure: Proportion of Patients Having Experienced at Least One Hypoglycaemic Event (Confirmed or Severe) Over the 52-week Double-blind Treatment Period.
timeFrame: From week 0 to week 52.
measure: Change From Baseline to Week 52 in HbA1c.
timeFrame: From week 0 to week 52.
measure: Proportion of Patients Achieving a Therapeutic Glycaemic Response at Week 52 Defined as HbA1c <7.0%
timeFrame: From week 0 to week 52
measure: Change From Baseline to Week 52 in Fasting Plasma Glucose (FPG)
timeFrame: From week 0 to week 52
measure: Change From Baseline to Week 52 in Insulin
timeFrame: From week 0 to week 52
measure: Change From Baseline to Week 52 in β-cell Function (as Measured by Homeostasis Model Assessment-β [HOMA-β]
timeFrame: From week 0 to week 52
Other outcomes:
Locations:
city: Feldbach
country: Austria
facility: Research Site
city: Graz
country: Austria
facility: Research Site
city: Salzburg
country: Austria
facility: Research Site
city: Vienna
country: Austria
facility: Research Site
city: Wien
country: Austria
facility: Research Site
city: Aalborg
country: Denmark
facility: Research Site
city: Ans by
country: Denmark
facility: Research Site
city: Kjellerup
country: Denmark
facility: Research Site
city: Kolding
country: Denmark
facility: Research Site
city: Norresundby
country: Denmark
facility: Research Site
city: Roskilde
country: Denmark
facility: Research Site
city: Roslev
country: Denmark
facility: Research Site
city: Vaerlose
country: Denmark
facility: Research Site
city: Viborg
country: Denmark
facility: Research Site
city: Viby J
country: Denmark
facility: Research Site
city: Harjavalta
country: Finland
facility: Research Site
city: Helsinki
country: Finland
facility: Research Site
city: Kuopio
country: Finland
facility: Research Site
city: Kuusankoski
country: Finland
facility: Research Site
city: Lahti
country: Finland
facility: Research Site
city: Oulu
country: Finland
facility: Research Site
city: Seinajoki
country: Finland
facility: Research Site
city: Sipoo
country: Finland
facility: Research Site
city: Tampere
country: Finland
facility: Research Site
city: Turku
country: Finland
facility: Research Site
city: Vantaa
country: Finland
facility: Research Site
city: Vimpeli
country: Finland
facility: Research Site
city: Chatellerault
country: France
facility: Research Site
city: La Rochelle
country: France
facility: Research Site
city: La Seyne Sur Mer
country: France
facility: Research Site
city: Laval
country: France
facility: Research Site
city: Seysses
country: France
facility: Research Site
city: Strasbourg
country: France
facility: Research Site
city: Tierce
country: France
facility: Research Site
city: Hamburg
country: Germany
facility: Research Site
state: HH
city: Augsburg
country: Germany
facility: Research Site
city: Darmstadt
country: Germany
facility: Research Site
city: Dresden
country: Germany
facility: Research Site
city: Essen
country: Germany
facility: Research Site
city: Gelnhausen
country: Germany
facility: Research Site
city: Hamburg
country: Germany
facility: Research Site
city: Magdeburg
country: Germany
facility: Research Site
city: Mayen
country: Germany
facility: Research Site
city: Munchen
country: Germany
facility: Research Site
city: Neumunster
country: Germany
facility: Research Site
city: Nurnberg
country: Germany
facility: Research Site
city: Pirna
country: Germany
facility: Research Site
city: Ratzeburg
country: Germany
facility: Research Site
city: Reinfeld
country: Germany
facility: Research Site
city: Sulzbach
country: Germany
facility: Research Site
city: Athens
country: Greece
facility: Research Site
city: Nikea
country: Greece
facility: Research Site
city: Thessaloniki
country: Greece
facility: Research Site
city: ACS
country: Hungary
facility: Research Site
city: Balatonfured
country: Hungary
facility: Research Site
city: Budapest
country: Hungary
facility: Research Site
city: ERD
country: Hungary
facility: Research Site
city: Gyongyos
country: Hungary
facility: Research Site
city: Komarom
country: Hungary
facility: Research Site
city: Milano
country: Italy
facility: Research Site
state: MI
city: Palermo
country: Italy
facility: Research Site
state: PA
city: Padova
country: Italy
facility: Research Site
state: PD
city: Pordenone
country: Italy
facility: Research Site
state: PN
city: Reggio Emilia
country: Italy
facility: Research Site
state: RE
city: Chieti
country: Italy
facility: Research Site
city: Napoli
country: Italy
facility: Research Site
city: Roma
country: Italy
facility: Research Site
city: Viterbo
country: Italy
facility: Research Site
city: Guadalajara
country: Mexico
facility: Research Site
state: Jalisco
city: Monterrey
country: Mexico
facility: Research Site
state: Nuevo Leon
city: Durango
country: Mexico
facility: Research Site
city: Aksdal
country: Norway
facility: Research Site
city: Alesund
country: Norway
facility: Research Site
city: Elverum
country: Norway
facility: Research Site
city: Halden
country: Norway
facility: Research Site
city: Hamar
country: Norway
facility: Research Site
city: Kirkenaer
country: Norway
facility: Research Site
city: Kongsvinger
country: Norway
facility: Research Site
city: Larvik
country: Norway
facility: Research Site
city: Lierskogen
country: Norway
facility: Research Site
city: Nord-lenangen
country: Norway
facility: Research Site
city: Oslo
country: Norway
facility: Research Site
city: ROA
country: Norway
facility: Research Site
city: Sandvika
country: Norway
facility: Research Site
city: Skedsmokorset
country: Norway
facility: Research Site
city: Sorumsand
country: Norway
facility: Research Site
city: Svelvik
country: Norway
facility: Research Site
city: Trondheim
country: Norway
facility: Research Site
city: Ulset
country: Norway
facility: Research Site
city: Sevilla
country: Spain
facility: Research Site
state: Andalucia
city: Oviedo
country: Spain
facility: Research Site
state: Asturias
city: Zamora
country: Spain
facility: Research Site
state: Castilla Y Leon
city: Getafe
country: Spain
facility: Research Site
state: Comunidad de Madrid
city: Madrid
country: Spain
facility: Research Site
state: Comunidad de Madrid
city: San Sebastian de Los Reyes
country: Spain
facility: Research Site
state: Comunidad de Madrid
city: Alicante
country: Spain
facility: Research Site
state: Comunidad Valenciana
city: A Coruna
country: Spain
facility: Research Site
state: Galicia
city: Begonte (lugo)
country: Spain
facility: Research Site
state: Galicia
city: Finspang
country: Sweden
facility: Research Site
city: Gavle
country: Sweden
facility: Research Site
city: Goteborg
country: Sweden
facility: Research Site
city: Jarfalla
country: Sweden
facility: Research Site
city: Jonkoping
country: Sweden
facility: Research Site
city: Lessebo
country: Sweden
facility: Research Site
city: Lund
country: Sweden
facility: Research Site
city: Odeshog
country: Sweden
facility: Research Site
city: Pitea
country: Sweden
facility: Research Site
city: Rattvik
country: Sweden
facility: Research Site
city: Stockholm
country: Sweden
facility: Research Site
city: Trollhattan
country: Sweden
facility: Research Site
city: Vastervik
country: Sweden
facility: Research Site
city: Fowey
country: United Kingdom
facility: Research Site
state: Cornwall
city: Nr Penzance
country: United Kingdom
facility: Research Site
state: Cornwall
city: Penzance
country: United Kingdom
facility: Research Site
state: Cornwall
city: Barnstaple
country: United Kingdom
facility: Research Site
state: Devon
city: Plymouth
country: United Kingdom
facility: Research Site
state: Devon
city: Annan
country: United Kingdom
facility: Research Site
state: Dumfries and Galloway
city: Canterbury
country: United Kingdom
facility: Research Site
state: Kent
city: Whitstable
country: United Kingdom
facility: Research Site
state: Kent
city: Frome
country: United Kingdom
facility: Research Site
state: Somerset
city: Bradford-on-avon
country: United Kingdom
facility: Research Site
state: Wiltshire
city: Trowbridge
country: United Kingdom
facility: Research Site
state: Wiltshire
city: Ayrshire
country: United Kingdom
facility: Research Site
city: Bath
country: United Kingdom
facility: Research Site
city: Cumbernauld
country: United Kingdom
facility: Research Site
city: Dundee
country: United Kingdom
facility: Research Site
city: Hamilton
country: United Kingdom
facility: Research Site
city: Middlesex
country: United Kingdom
facility: Research Site
city: Motherwell
country: United Kingdom
facility: Research Site
city: Somerset
country: United Kingdom
facility: Research Site
city: Wellingborough
country: United Kingdom
facility: Research Site
Study officials:
References:
citation: 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.
citation: 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.