Treatment Effect of Saxagliptin Compared With Placebo in Patients With Type 2 Diabetes and Renal Impairment
NCT ID: NCT00614939
Last Updated: 2011-05-19
Study Results
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View full resultsBasic Information
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COMPLETED
PHASE3
572 participants
INTERVENTIONAL
2008-01-31
2010-03-31
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
TRIPLE
Study Groups
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Saxa
Saxagliptin
Saxagliptin
2.5 mg once daily oral dose
Placebo
Placebo to match
Placebo
Placebo
Interventions
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Saxagliptin
2.5 mg once daily oral dose
Placebo
Placebo
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* Documented history of CrCl \<50 ml/min within the 3 months prior to enrollment
* HbA1c ≥7.0% and ≤11.0%
Exclusion Criteria
* Previous or current treatment with any DPP-IV inhibitor and/or GLP-1 mimetic.
18 Years
ALL
No
Sponsors
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Bristol-Myers Squibb
INDUSTRY
AstraZeneca
INDUSTRY
Responsible Party
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AstraZeneca
Principal Investigators
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Peter Ohman, MD, PhD
Role: STUDY_DIRECTOR
AstraZeneca
Deborah Price, MSc
Role: STUDY_CHAIR
AstraZeneca
Locations
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Research Site
Concord, California, United States
Research Site
Sacramento, California, United States
Research Site
Denver, Colorado, United States
Research Site
Topeka, Kansas, United States
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Baltimore, Maryland, United States
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Great Falls, Montana, United States
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Greenville, North Carolina, United States
Research Site
Morehead City, North Carolina, United States
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Cincinnati, Ohio, United States
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Corpus Christi, Texas, United States
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Charleston, West Virginia, United States
Research Site
Brest, , Belarus
Research Site
Homyel, , Belarus
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Minsk, , Belarus
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Dimitrovgrad, , Bulgaria
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Sofia, , Bulgaria
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Veliko Tarnovo, , Bulgaria
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Rijeka, Croatia, Croatia
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Karlovac, , Croatia
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Osijek, , Croatia
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Split, , Croatia
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Zagreb, , Croatia
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Moravský Krumlov, , Czechia
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Prague, , Czechia
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Teplice, , Czechia
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Ústí nad Labem, , Czechia
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Znojmo, , Czechia
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Tallinn, , Estonia
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Dieburg, , Germany
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Düsseldorf, , Germany
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Hanover, , Germany
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Heidelberg, , Germany
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Mannheim, , Germany
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Debrecen, , Hungary
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Győr, , Hungary
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Kalocsa, , Hungary
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Kecskemét, , Hungary
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Zalaegerszeg, , Hungary
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Riga, , Latvia
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Kaunas, , Lithuania
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Klaipėda, , Lithuania
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Panevezys, , Lithuania
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Vilnius, , Lithuania
Research Site
Lodz, 90-153, Poland
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Bialystok, , Poland
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Ciechanów, , Poland
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Golub-Dobrzyń, , Poland
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Grodzisk Mazowiecki, , Poland
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Katowice, , Poland
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Krakow, , Poland
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Maków Mazowiecki, , Poland
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Radom, , Poland
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Szczecin, , Poland
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Warsaw, , Poland
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Wroclaw, , Poland
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Zabrze, , Poland
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Bacau, Bacău, Romania
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Brasov, Brașov County, Romania
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Satu Mare, Satu Mare County, Romania
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Bucharest, , Romania
Research Site
Sf Gheorghe, , Romania
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Chelyabinsk, , Russia
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Moscow, , Russia
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Ryazan, , Russia
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Saint Petersburg, , Russia
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Yaroslavl, , Russia
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Dnipropetrovsk, , Ukraine
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Ivano-Frankivsk, , Ukraine
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Kharkiv, , Ukraine
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Kyiv, , Ukraine
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Mykolayiv, , Ukraine
Research Site
Sumy, , Ukraine
Research Site
Ternopil, , Ukraine
Research Site
Zaporizhzhya, , Ukraine
Countries
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References
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Nowicki M, Rychlik I, Haller H, Warren ML, Suchower L, Gause-Nilsson I; D1680C00007 Investigators. Saxagliptin improves glycaemic control and is well tolerated in patients with type 2 diabetes mellitus and renal impairment. Diabetes Obes Metab. 2011 Jun;13(6):523-32. doi: 10.1111/j.1463-1326.2011.01382.x.
Other Identifiers
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EudraCT number 2007-004951-12
Identifier Type: -
Identifier Source: secondary_id
D1680C00007
Identifier Type: -
Identifier Source: org_study_id
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