Clinical trial NCT00575588: 52-week add-on to Metformin Comparison of Saxagliptin and Sulphonylurea, With a 52-week Extension Period
Official title: A 52-Week International, Multi-centre, Randomized, Parallel-group, Double-blind, Active-controlled, Phase III Study With a 52-Week Extension Period to Evaluate the Safety and Efficacy of Saxagliptin in Combination With Metformin Compared With Sulphonylurea in Combination With Metformin in Adult Patients With Type 2 Diabetes Who Have Inadequate Glycaemic Control on Metformin Therapy Alone.
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Type 2 Diabetes
Keywords: DPP-4 Inhibitors
HbA1c
incretins
Lead sponsor: AstraZeneca
Sponsor class: INDUSTRY
Collaborators: name: Bristol-Myers Squibb
First posted: 2007-12-18
Enrollment: 891
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: Saxagliptin is a new investigational medication being developed for treatment of type 2 diabetes. This study is designed to assess the efficacy and tolerability of saxagliptin in addition to metformin and compare to sulphonylurea in addition with metformin.


Eligibility criteria: Inclusion Criteria:

* Diagnosed with type 2 diabetes,
* Treatment with metformin alone on stable doses of 1500 mg or higher per day for at least 8 weeks prior to Visit 1,
* HbA1c \>6.5% and ≤10.0%

Exclusion Criteria:

* Type 1 diabetes,
* history of diabetic ketoacidosis or hyperosmolar non-ketonic coma,
* Insulin therapy within one year of enrolment (with the exception of insulin therapy during a hospitalization or use in gestational diabetes)

Primary outcomes:
measure: Hemoglobin A1c (HbA1c) Change From Baseline to Week 52
timeFrame: Baseline to 52 Weeks
Secondary outcomes:
measure: Proportion of Participants Reporting at Least One Episode of Any Hypoglycaemic Event Over 52 Weeks
timeFrame: From Baseline to Week 52
measure: Body Weight Change From Baseline to Week 52
timeFrame: Baseline, Week 52 (Last Observation Carried Forward)
measure: Mean Slope of the Regressions of Change From Week 24 to Week 52 in HbA1c
timeFrame: Week 24 to Week 52
Other outcomes:
measure: Hemoglobin A1c (HbA1c) Change From Baseline to Week 104
timeFrame: Baseline, Week 104
measure: Proportion of Participants Reporting at Least One Episode of Any Hypoglycaemic Event Over 104 Weeks
timeFrame: Baseline, Week 104
measure: Body Weight Change From Baseline to Week 104
timeFrame: Baseline, Week 104
measure: Mean Slope of the Regressions of Change From Week 24 to Week 104 in HbA1c
timeFrame: Week 24 to Week 104
Locations:
city: Hanko
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: Mikkeli
country: Finland
facility: Research Site
city: Oulu
country: Finland
facility: Research Site
city: Tampere
country: Finland
facility: Research Site
city: Aschaffenburg
country: Germany
facility: Research Site
city: Berlin
country: Germany
facility: Research Site
city: Dortmund
country: Germany
facility: Research Site
city: Frankfurt
country: Germany
facility: Research Site
city: Hamburg
country: Germany
facility: Research Site
city: Hannover
country: Germany
facility: Research Site
city: Mainz
country: Germany
facility: Research Site
city: Mannheim
country: Germany
facility: Research Site
city: Mulheim
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: Rhaunen
country: Germany
facility: Research Site
city: Schmiedeberg
country: Germany
facility: Research Site
city: Tubingen
country: Germany
facility: Research Site
city: Wahlstedt
country: Germany
facility: Research Site
city: Weinheim
country: Germany
facility: Research Site
city: Balatonfured
country: Hungary
facility: Research Site
city: Bekescsaba
country: Hungary
facility: Research Site
city: Budapest
country: Hungary
facility: Research Site
city: Debrecen
country: Hungary
facility: Research Site
city: Gyula
country: Hungary
facility: Research Site
city: Kalocsa
country: Hungary
facility: Research Site
city: Kaposvar
country: Hungary
facility: Research Site
city: Kecskemet
country: Hungary
facility: Research Site
city: Miskolc
country: Hungary
facility: Research Site
city: Mosonmagyarovar
country: Hungary
facility: Research Site
city: Nyiregyhaza
country: Hungary
facility: Research Site
city: Szekesfehervar
country: Hungary
facility: Research Site
city: Bangalore
country: India
facility: Research Site
state: Karnataka
city: Indore
country: India
facility: Research Site
state: Madhya Pradesh
city: Mumbai
country: India
facility: Research Site
state: Mashatra
city: Jaipur
country: India
facility: Research Site
state: Rajasthan
city: Guri
country: Korea, Republic of
facility: Research Site
state: Gyeonggi-do
city: Seongnam
country: Korea, Republic of
facility: Research Site
state: Gyeonggi-do
city: Wonju
country: Korea, Republic of
facility: Research Site
state: Kangwon-do
city: Incheon
country: Korea, Republic of
facility: Research Site
city: Seoul
country: Korea, Republic of
facility: Research Site
city: Uijeongbu-si
country: Korea, Republic of
facility: Research Site
city: Beek En Donk
country: Netherlands
facility: Research Site
city: Den Bosch
country: Netherlands
facility: Research Site
city: Den Haag
country: Netherlands
facility: Research Site
city: Deurne
country: Netherlands
facility: Research Site
city: Dordrecht
country: Netherlands
facility: Research Site
city: Losser
country: Netherlands
facility: Research Site
city: Nijverdal
country: Netherlands
facility: Research Site
city: Rijswijk
country: Netherlands
facility: Research Site
city: Roelofarendsveen
country: Netherlands
facility: Research Site
city: Rotterdam
country: Netherlands
facility: Research Site
city: Volendam
country: Netherlands
facility: Research Site
city: Bergen
country: Norway
facility: Research Site
city: Elverum
country: Norway
facility: Research Site
city: Flatasen
country: Norway
facility: Research Site
city: Hamar
country: Norway
facility: Research Site
city: Honefoss
country: Norway
facility: Research Site
city: Inderoy
country: Norway
facility: Research Site
city: Oslo
country: Norway
facility: Research Site
city: Radal
country: Norway
facility: Research Site
city: Skedsmokorset
country: Norway
facility: Research Site
city: Sogndal
country: Norway
facility: Research Site
city: Spikkestad
country: Norway
facility: Research Site
city: Trollasen
country: Norway
facility: Research Site
city: Kazan
country: Russian Federation
facility: Research Site
city: Moscow
country: Russian Federation
facility: Research Site
city: Nizhnii Novgorod
country: Russian Federation
facility: Research Site
city: St. Petersburg
country: Russian Federation
facility: Research Site
city: Yaroslavl
country: Russian Federation
facility: Research Site
city: Dolny Kubin
country: Slovakia
facility: Research Site
city: Kosice - Tahanovce
country: Slovakia
facility: Research Site
city: Moldava Nad Bodvou
country: Slovakia
facility: Research Site
city: Ruzomberok
country: Slovakia
facility: Research Site
city: Trnava
country: Slovakia
facility: Research Site
city: Zilina
country: Slovakia
facility: Research Site
city: Annan
country: United Kingdom
facility: Research Site
state: Dumfries and Galloway
city: Whitstable
country: United Kingdom
facility: Research Site
state: Kent
city: Hamilton
country: United Kingdom
facility: Research Site
state: Lanarkshire
city: Salford
country: United Kingdom
facility: Research Site
state: Manchester
city: Crawley
country: United Kingdom
facility: Research Site
state: West Sussex
city: Bradford-on-avon
country: United Kingdom
facility: Research Site
state: Wiltshire
city: Blackpool
country: United Kingdom
facility: Research Site
city: Coatbridge
country: United Kingdom
facility: Research Site
city: Coventry
country: United Kingdom
facility: Research Site
city: Glasgow
country: United Kingdom
facility: Research Site
city: Motherwell
country: United Kingdom
facility: Research Site
city: Newcastle
country: United Kingdom
facility: Research Site
city: Sheffield
country: United Kingdom
facility: Research Site
city: Ho Chi Minh City
country: Vietnam
facility: Research Site
city: Ho Chi Minh
country: Vietnam
facility: Research Site
Study officials:
affiliation: University of Munich, Germany
name: Burkhard Goke
role: PRINCIPAL_INVESTIGATOR
affiliation: AstraZeneca
name: Peter Ohman, MD
role: STUDY_DIRECTOR
affiliation: AstraZeneca
name: Deborah Price, MSc
role: STUDY_CHAIR
References:
citation: Cook W, Minervini G, Bryzinski B, Hirshberg B. Saxagliptin efficacy and safety in patients with type 2 diabetes mellitus stratified by cardiovascular disease history and cardiovascular risk factors: analysis of 3 clinical trials. Postgrad Med. 2014 Oct;126(6):19-32. doi: 10.3810/pgm.2014.10.2818.
citation: Mintz ML, Minervini G. Saxagliptin versus glipizide as add-on therapy to metformin: assessment of hypoglycemia. Curr Med Res Opin. 2014 May;30(5):761-70. doi: 10.1185/03007995.2014.880674. Epub 2014 Jan 30.
citation: Goke B, Gallwitz B, Eriksson JG, Hellqvist A, Gause-Nilsson I. Saxagliptin vs. glipizide as add-on therapy in patients with type 2 diabetes mellitus inadequately controlled on metformin alone: long-term (52-week) extension of a 52-week randomised controlled trial. Int J Clin Pract. 2013 Apr;67(4):307-16. doi: 10.1111/ijcp.12119.