Treatment Effect of Saxagliptin Compared With Placebo in Patients With Type 2 Diabetes and Renal Impairment
A Short-term 12-Week, Multi-centre, Randomized, Parallel-group, Double-blind, Placebo-controlled Study to Evaluate the Treatment Effect of Saxagliptin Compared With Placebo in Adult Patients With Type 2 Diabetes and Renal Impairment (Moderate, Severe, and End-Stage) With an Additional 40-week, Randomized, Double-blind, Placebo-controlled Long-term Observational Period.
2 other identifiers
interventional
572
14 countries
74
Brief Summary
Saxagliptin is a new investigational medication being developed for treatment of type 2 diabetes. This study is designed to test the efficacy of once daily saxagliptin in renally impaired patients.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for phase_3 type-2-diabetes
Started Jan 2008
Typical duration for phase_3 type-2-diabetes
74 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
January 1, 2008
CompletedFirst Submitted
Initial submission to the registry
January 31, 2008
CompletedFirst Posted
Study publicly available on registry
February 13, 2008
CompletedPrimary Completion
Last participant's last visit for primary outcome
June 1, 2009
CompletedStudy Completion
Last participant's last visit for all outcomes
March 1, 2010
CompletedResults Posted
Study results publicly available
July 7, 2010
CompletedMay 19, 2011
May 1, 2011
1.4 years
January 31, 2008
June 7, 2010
May 16, 2011
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Absolute Change From Baseline in Glycosylated Haemoglobin A1c (HbA1c) Level to Week 12 Last Observation Carried Forward (LOCF)
Adjusted\* mean change from baseline in HbA1c achieved with saxagliptin 2.5 mg once daily versus placebo at Week 12 (Full Analysis Set). HbA1c is a continuous measure, the change from baseline for each participant is calculated at the Week 12 value minus the baseline value.
Baseline , Week 12 (LOCF)
Secondary Outcomes (9)
Absolute Change From Baseline in Fasting Plasma Glucose (FPG) to Week 12 (LOCF)- Moderate Renal Impairment Subgroup
Baseline, Week 12 (LOCF)
Absolute Change From Baseline in Fasting Plasma Glucose (FPG) to Week 12 (LOCF) - Severe Renal Impairment Subgroup
Baseline, Week 12 (LOCF)
Absolute Change From Baseline in Fasting Plasma Glucose (FPG) to Week 12 (LOCF) - End-Stage Renal Impairment Subgroup
Baseline, Week 12 (LOCF)
Absolute Change From Baseline in Fasting Plasma Glucose (FPG) to Week 12 (LOCF) - Moderate Renal Impairment Subgroup
Baseline, Week 12 (LOCF)
Absolute Change From Baseline in Glycosylated Haemoglobin A1c (HbA1c) Level to Week 52
Baseline , Week 52
- +4 more secondary outcomes
Study Arms (2)
Saxa
EXPERIMENTALSaxagliptin
Placebo
NO INTERVENTIONPlacebo to match
Interventions
Eligibility Criteria
You may qualify if:
- Diagnosed with type 2 diabetes
- Documented history of CrCl \<50 ml/min within the 3 months prior to enrollment
- HbA1c ≥7.0% and ≤11.0%
You may not qualify if:
- Type 1 diabetes, history of diabetic ketoacidosis or hyposmolar non-ketonic coma
- Previous or current treatment with any DPP-IV inhibitor and/or GLP-1 mimetic.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- AstraZenecalead
- Bristol-Myers Squibbcollaborator
Study Sites (74)
Research Site
Concord, California, United States
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Sacramento, California, United States
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Denver, Colorado, United States
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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
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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
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Brest, Belarus
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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
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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
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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
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Sumy, Ukraine
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Ternopil, Ukraine
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Zaporizhzhya, Ukraine
Related Publications (1)
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.
PMID: 21332627DERIVED
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Results Point of Contact
- Title
- Gerard Lynch
- Organization
- AstraZeneca
Study Officials
- STUDY DIRECTOR
Peter Ohman, MD, PhD
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
- TRIPLE
- Who Masked
- PARTICIPANT, CARE PROVIDER, INVESTIGATOR
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
Study Record Dates
First Submitted
January 31, 2008
First Posted
February 13, 2008
Study Start
January 1, 2008
Primary Completion
June 1, 2009
Study Completion
March 1, 2010
Last Updated
May 19, 2011
Results First Posted
July 7, 2010
Record last verified: 2011-05