52-week add-on to Metformin Comparison of Saxagliptin and Sulphonylurea, With a 52-week Extension Period
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.
2 other identifiers
interventional
891
11 countries
94
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for phase_3 type-2-diabetes
Started Dec 2007
Typical duration for phase_3 type-2-diabetes
94 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
December 1, 2007
CompletedFirst Submitted
Initial submission to the registry
December 14, 2007
CompletedFirst Posted
Study publicly available on registry
December 18, 2007
CompletedPrimary Completion
Last participant's last visit for primary outcome
August 1, 2009
CompletedStudy Completion
Last participant's last visit for all outcomes
August 1, 2010
CompletedResults Posted
Study results publicly available
September 6, 2010
CompletedMarch 21, 2012
March 1, 2012
1.7 years
December 14, 2007
August 10, 2010
March 20, 2012
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Hemoglobin A1c (HbA1c) Change From Baseline to Week 52
Adjusted mean change from baseline in HbA1c achieved with saxagliptin added on to metformin versus glipizide added on to metformin at Week 52 (Per Protocol Analysis Set). HbA1c is a continuous measure, the change from baseline for each participant is calculated as the Week 52 value minus the baseline value.
Baseline to 52 Weeks
Secondary Outcomes (3)
Proportion of Participants Reporting at Least One Episode of Any Hypoglycaemic Event Over 52 Weeks
From Baseline to Week 52
Body Weight Change From Baseline to Week 52
Baseline, Week 52 (Last Observation Carried Forward)
Mean Slope of the Regressions of Change From Week 24 to Week 52 in HbA1c
Week 24 to Week 52
Other Outcomes (4)
Hemoglobin A1c (HbA1c) Change From Baseline to Week 104
Baseline, Week 104
Proportion of Participants Reporting at Least One Episode of Any Hypoglycaemic Event Over 104 Weeks
Baseline, Week 104
Body Weight Change From Baseline to Week 104
Baseline, Week 104
- +1 more other outcomes
Study Arms (2)
Saxagliptin
EXPERIMENTALGlipizide
EXPERIMENTALInterventions
Glipizide 5-20 mg capsules (titrated to optimal effect or highest tolerable dose during 18 weeks)
Eligibility Criteria
You may qualify if:
- 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%
You may not qualify if:
- 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)
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- AstraZenecalead
- Bristol-Myers Squibbcollaborator
Study Sites (94)
Research Site
Hanko, Finland
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Helsinki, Finland
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Kuopio, Finland
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Kuusankoski, Finland
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Mikkeli, Finland
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Oulu, Finland
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Tampere, Finland
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Aschaffenburg, Germany
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Berlin, Germany
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Dortmund, Germany
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Frankfurt, Germany
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Hamburg, Germany
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Hanover, Germany
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Mainz, Germany
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Mannheim, Germany
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Mülheim, Germany
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Pirna, Germany
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Ratzeburg, Germany
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Reinfeld, Germany
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Rhaunen, Germany
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Schmiedeberg, Germany
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Tübingen, Germany
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Wahlstedt, Germany
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Weinheim, Germany
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Balatonfüred, Hungary
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Békéscsaba, Hungary
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Budapest, Hungary
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Debrecen, Hungary
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Gyula, Hungary
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Kalocsa, Hungary
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Kaposvár, Hungary
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Kecskemét, Hungary
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Miskolc, Hungary
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Mosonmagyaróvár, Hungary
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Nyíregyháza, Hungary
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Székesfehérvár, Hungary
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Bangalore, Karnataka, India
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Indore, Madhya Pradesh, India
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Mumbai, Mashatra, India
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Jaipur, Rajasthan, India
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's-Hertogenbosch, Netherlands
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Beek en Donk, Netherlands
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Deurne, Netherlands
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Dordrecht, Netherlands
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Losser, Netherlands
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Nijverdal, Netherlands
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Rijswijk, Netherlands
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Roelofarendsveen, Netherlands
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Rotterdam, Netherlands
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The Hague, Netherlands
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Volendam, Netherlands
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Bergen, Norway
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Elverum, Norway
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Flatåsen, Norway
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Hamar, Norway
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Hønefoss, Norway
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Inderoy, Norway
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Oslo, Norway
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Rådal, Norway
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Skedsmokorset, Norway
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Sogndal, Norway
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Spikkestad, Norway
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Trollåsen, Norway
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Kazan', Russia
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Moscow, Russia
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Nizhny Novgorod, Russia
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Saint Petersburg, Russia
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Yaroslavl, Russia
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Dolný Kubín, Slovakia
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Kosice - Tahanovce, Slovakia
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Moldava nad Bodvou, Slovakia
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Ružomberok, Slovakia
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Trnava, Slovakia
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Žilina, Slovakia
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Wŏnju, Gangwon-do, South Korea
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Guri-si, Gyeonggi-do, South Korea
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Seongnam-si, Gyeonggi-do, South Korea
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Incheon, South Korea
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Seoul, South Korea
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Uijeongbu-si, South Korea
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Annan, Dumfries and Galloway, United Kingdom
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Whitstable, Kent, United Kingdom
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Hamilton, Lanarkshire, United Kingdom
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Salford, Manchester, United Kingdom
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Crawley, West Sussex, United Kingdom
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Bradford-on-Avon, Wiltshire, United Kingdom
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Blackpool, United Kingdom
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Coatbridge, United Kingdom
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Coventry, United Kingdom
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Glasgow, United Kingdom
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Motherwell, United Kingdom
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Newcastle, United Kingdom
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Sheffield, United Kingdom
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Ho Chi Minh City, Vietnam
Related Publications (3)
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.
PMID: 25414932DERIVEDMintz 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.
PMID: 24397584DERIVEDGoke 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.
PMID: 23638466DERIVED
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Results Point of Contact
- Title
- Gerard Lynch
- Organization
- AstraZeneca
Study Officials
- PRINCIPAL INVESTIGATOR
Burkhard Goke
University of Munich, Germany
- STUDY DIRECTOR
Peter Ohman, MD
AstraZeneca
- STUDY CHAIR
Deborah Price, MSc
AstraZeneca
Publication Agreements
- PI is Sponsor Employee
- No
- Restrictive Agreement
- No
Study Design
- Study Type
- interventional
- Phase
- phase 3
- Allocation
- RANDOMIZED
- Masking
- QUADRUPLE
- Who Masked
- PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
December 14, 2007
First Posted
December 18, 2007
Study Start
December 1, 2007
Primary Completion
August 1, 2009
Study Completion
August 1, 2010
Last Updated
March 21, 2012
Results First Posted
September 6, 2010
Record last verified: 2012-03