52-week add-on to Metformin Comparison of Saxagliptin and Sulphonylurea, With a 52-week Extension Period
NCT ID: NCT00575588
Last Updated: 2012-03-21
Study Results
Outcome measurements, participant flow, baseline characteristics, and adverse events have been published for this study.
View full resultsBasic Information
Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.
COMPLETED
PHASE3
891 participants
INTERVENTIONAL
2007-12-31
2010-08-31
Brief Summary
Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.
Related Clinical Trials
Explore similar clinical trials based on study characteristics and research focus.
Safety and Efficacy of Saxagliptin Plus Insulin With or Without Metformin
NCT00757588
18-week add-on to Metformin Comparison of Saxagliptin and Sitagliptin in Adult Patients With Type 2 Diabetes (T2D)
NCT00666458
Study to Evaluate the Efficacy and Safety of Saxagliptin Co-administered With Dapagliflozin in Combination With Metformin Compared to Sitagliptin in Combination With Metformin in Adult Patients With Type 2 Diabetes Who Have Inadequate Glycemic Control on Metformin Therapy Alone
NCT02284893
Evaluate Efficacy and Safety of Saxagliptin in Combination With Metformin in Adult Patients With Type 2 Diabetes
NCT00661362
Efficacy and Safety Study of Saxagliptin + Metformin Immediate Release (IR) Versus Metformin IR Alone in Type 2 Diabetes Mellitus
NCT00885378
Detailed Description
Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.
Conditions
See the medical conditions and disease areas that this research is targeting or investigating.
Study Design
Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.
RANDOMIZED
PARALLEL
TREATMENT
QUADRUPLE
Study Groups
Review each arm or cohort in the study, along with the interventions and objectives associated with them.
Saxagliptin
Metformin
open-label metformin
Saxagliptin
Saxagliptin 5 mg tablets
Glipizide
Metformin
open-label metformin
Sulphonylurea
Glipizide 5-20 mg capsules (titrated to optimal effect or highest tolerable dose during 18 weeks)
Interventions
Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.
Metformin
open-label metformin
Sulphonylurea
Glipizide 5-20 mg capsules (titrated to optimal effect or highest tolerable dose during 18 weeks)
Saxagliptin
Saxagliptin 5 mg tablets
Other Intervention Names
Discover alternative or legacy names that may be used to describe the listed interventions across different sources.
Eligibility Criteria
Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.
Inclusion Criteria
* 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
* 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)
18 Years
ALL
No
Sponsors
Meet the organizations funding or collaborating on the study and learn about their roles.
Bristol-Myers Squibb
INDUSTRY
AstraZeneca
INDUSTRY
Responsible Party
Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.
Principal Investigators
Learn about the lead researchers overseeing the trial and their institutional affiliations.
Burkhard Goke
Role: PRINCIPAL_INVESTIGATOR
University of Munich, Germany
Peter Ohman, MD
Role: STUDY_DIRECTOR
AstraZeneca
Deborah Price, MSc
Role: STUDY_CHAIR
AstraZeneca
Locations
Explore where the study is taking place and check the recruitment status at each participating site.
Research Site
Hanko, , Finland
Research Site
Helsinki, , Finland
Research Site
Kuopio, , Finland
Research Site
Kuusankoski, , Finland
Research Site
Mikkeli, , Finland
Research Site
Oulu, , Finland
Research Site
Tampere, , Finland
Research Site
Aschaffenburg, , Germany
Research Site
Berlin, , Germany
Research Site
Dortmund, , Germany
Research Site
Frankfurt, , Germany
Research Site
Hamburg, , Germany
Research Site
Hanover, , Germany
Research Site
Mainz, , Germany
Research Site
Mannheim, , Germany
Research Site
Mülheim, , Germany
Research Site
Pirna, , Germany
Research Site
Ratzeburg, , Germany
Research Site
Reinfeld, , Germany
Research Site
Rhaunen, , Germany
Research Site
Schmiedeberg, , Germany
Research Site
Tübingen, , Germany
Research Site
Wahlstedt, , Germany
Research Site
Weinheim, , Germany
Research Site
Balatonfüred, , Hungary
Research Site
Békéscsaba, , Hungary
Research Site
Budapest, , Hungary
Research Site
Debrecen, , Hungary
Research Site
Gyula, , Hungary
Research Site
Kalocsa, , Hungary
Research Site
Kaposvár, , Hungary
Research Site
Kecskemét, , Hungary
Research Site
Miskolc, , Hungary
Research Site
Mosonmagyaróvár, , Hungary
Research Site
Nyíregyháza, , Hungary
Research Site
Székesfehérvár, , Hungary
Research Site
Bangalore, Karnataka, India
Research Site
Indore, Madhya Pradesh, India
Research Site
Mumbai, Mashatra, India
Research Site
Jaipur, Rajasthan, India
Research Site
's-Hertogenbosch, , Netherlands
Research Site
Beek en Donk, , Netherlands
Research Site
Deurne, , Netherlands
Research Site
Dordrecht, , Netherlands
Research Site
Losser, , Netherlands
Research Site
Nijverdal, , Netherlands
Research Site
Rijswijk, , Netherlands
Research Site
Roelofarendsveen, , Netherlands
Research Site
Rotterdam, , Netherlands
Research Site
The Hague, , Netherlands
Research Site
Volendam, , Netherlands
Research Site
Bergen, , Norway
Research Site
Elverum, , Norway
Research Site
Flatåsen, , Norway
Research Site
Hamar, , Norway
Research Site
Hønefoss, , Norway
Research Site
Inderoy, , Norway
Research Site
Oslo, , Norway
Research Site
Rådal, , Norway
Research Site
Skedsmokorset, , Norway
Research Site
Sogndal, , Norway
Research Site
Spikkestad, , Norway
Research Site
Trollåsen, , Norway
Research Site
Kazan', , Russia
Research Site
Moscow, , Russia
Research Site
Nizhny Novgorod, , Russia
Research Site
Saint Petersburg, , Russia
Research Site
Yaroslavl, , Russia
Research Site
Dolný Kubín, , Slovakia
Research Site
Kosice - Tahanovce, , Slovakia
Research Site
Moldava nad Bodvou, , Slovakia
Research Site
Ružomberok, , Slovakia
Research Site
Trnava, , Slovakia
Research Site
Žilina, , Slovakia
Research Site
Wŏnju, Gangwon-do, South Korea
Research Site
Guri-si, Gyeonggi-do, South Korea
Research Site
Seongnam-si, Gyeonggi-do, South Korea
Research Site
Incheon, , South Korea
Research Site
Seoul, , South Korea
Research Site
Uijeongbu-si, , South Korea
Research Site
Annan, Dumfries and Galloway, United Kingdom
Research Site
Whitstable, Kent, United Kingdom
Research Site
Hamilton, Lanarkshire, United Kingdom
Research Site
Salford, Manchester, United Kingdom
Research Site
Crawley, West Sussex, United Kingdom
Research Site
Bradford-on-Avon, Wiltshire, United Kingdom
Research Site
Blackpool, , United Kingdom
Research Site
Coatbridge, , United Kingdom
Research Site
Coventry, , United Kingdom
Research Site
Glasgow, , United Kingdom
Research Site
Motherwell, , United Kingdom
Research Site
Newcastle, , United Kingdom
Research Site
Sheffield, , United Kingdom
Research Site
Ho Chi Minh City, , Vietnam
Countries
Review the countries where the study has at least one active or historical site.
References
Explore related publications, articles, or registry entries linked to this study.
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.
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.
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.
Other Identifiers
Review additional registry numbers or institutional identifiers associated with this trial.
EudraCT number 2007-003998-55
Identifier Type: -
Identifier Source: secondary_id
D1680C00001
Identifier Type: -
Identifier Source: org_study_id
More Related Trials
Additional clinical trials that may be relevant based on similarity analysis.