Clinical trial NCT00614939: Treatment Effect of Saxagliptin Compared With Placebo in Patients With Type 2 Diabetes and Renal Impairment
Official title: 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.
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Type 2 Diabetes
Keywords: DPP-4 inhibitors
HbA1c
incretins
Renal Impairment
Lead sponsor: AstraZeneca
Sponsor class: INDUSTRY
Collaborators: name: Bristol-Myers Squibb
First posted: 2008-02-13
Enrollment: 572
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 test the efficacy of once daily saxagliptin in renally impaired patients.


Eligibility criteria: Inclusion Criteria:

* 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%

Exclusion Criteria:

* 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.

Primary outcomes:
measure: Absolute Change From Baseline in Glycosylated Haemoglobin A1c (HbA1c) Level to Week 12 Last Observation Carried Forward (LOCF)
timeFrame: Baseline , Week 12 (LOCF)
Secondary outcomes:
measure: Absolute Change From Baseline in Fasting Plasma Glucose (FPG) to Week 12 (LOCF)- Moderate Renal Impairment Subgroup
timeFrame: Baseline, Week 12 (LOCF)
measure: Absolute Change From Baseline in Fasting Plasma Glucose (FPG) to Week 12 (LOCF) - Severe Renal Impairment Subgroup
timeFrame: Baseline, Week 12 (LOCF)
measure: Absolute Change From Baseline in Fasting Plasma Glucose (FPG) to Week 12 (LOCF) - End-Stage Renal Impairment Subgroup
timeFrame: Baseline, Week 12 (LOCF)
measure: Absolute Change From Baseline in Fasting Plasma Glucose (FPG) to Week 12 (LOCF) - Moderate Renal Impairment Subgroup
timeFrame: Baseline, Week 12 (LOCF)
measure: Absolute Change From Baseline in Glycosylated Haemoglobin A1c (HbA1c) Level to Week 52
timeFrame: Baseline , Week 52
measure: Absolute Change From Baseline in Fasting Plasma Glucose (FPG) to Week 52 - Moderate Renal Impairment Subgroup
timeFrame: Baseline, Week 52
measure: Absolute Change From Baseline in Fasting Plasma Glucose (FPG) to Week 52 - Severe Renal Impairment Subgroup
timeFrame: Baseline, Week 52
measure: Absolute Change From Baseline in Fasting Plasma Glucose (FPG) to Week 52 - End-Stage Renal Impairment Subgroup
timeFrame: Baseline, Week 52
measure: Absolute Change From Baseline in Fasting Plasma Glucose (FPG) to Week 52 - Moderate Renal Impairment Subgroup
timeFrame: Baseline, Week 52
Other outcomes:
Locations:
city: Concord
country: United States
facility: Research Site
state: California
city: Sacramento
country: United States
facility: Research Site
state: California
city: Denver
country: United States
facility: Research Site
state: Colorado
city: Topeka
country: United States
facility: Research Site
state: Kansas
city: Baltimore
country: United States
facility: Research Site
state: Maryland
city: Great Falls
country: United States
facility: Research Site
state: Montana
city: Greenville
country: United States
facility: Research Site
state: North Carolina
city: Morehead City
country: United States
facility: Research Site
state: North Carolina
city: Cincinnati
country: United States
facility: Research Site
state: Ohio
city: Corpus Christi
country: United States
facility: Research Site
state: Texas
city: Charleston
country: United States
facility: Research Site
state: West Virginia
city: Brest
country: Belarus
facility: Research Site
city: Gomel
country: Belarus
facility: Research Site
city: Minsk
country: Belarus
facility: Research Site
city: Dimitrovgrad
country: Bulgaria
facility: Research Site
city: Sofia
country: Bulgaria
facility: Research Site
city: Veliko Tarnovo
country: Bulgaria
facility: Research Site
city: Karlovac
country: Croatia
facility: Research Site
city: Osijek
country: Croatia
facility: Research Site
city: Rijeka
country: Croatia
facility: Research Site
city: Split
country: Croatia
facility: Research Site
city: Zagreb
country: Croatia
facility: Research Site
city: Moravsky Krumlov
country: Czech Republic
facility: Research Site
city: Praha 10
country: Czech Republic
facility: Research Site
city: Teplice
country: Czech Republic
facility: Research Site
city: Usti Nad Labem
country: Czech Republic
facility: Research Site
city: Znojmo
country: Czech Republic
facility: Research Site
city: Tallinn
country: Estonia
facility: Research Site
city: Dieburg
country: Germany
facility: Research Site
city: Dusseldorf
country: Germany
facility: Research Site
city: Hannover
country: Germany
facility: Research Site
city: Heidelberg
country: Germany
facility: Research Site
city: Mannheim
country: Germany
facility: Research Site
city: Debrecen
country: Hungary
facility: Research Site
city: Gyor
country: Hungary
facility: Research Site
city: Kalocsa
country: Hungary
facility: Research Site
city: Kecskemet
country: Hungary
facility: Research Site
city: Zalaegerszeg
country: Hungary
facility: Research Site
city: Riga
country: Latvia
facility: Research Site
city: Kaunas
country: Lithuania
facility: Research Site
city: Klaipeda
country: Lithuania
facility: Research Site
city: Panevezys
country: Lithuania
facility: Research Site
city: Vilnius
country: Lithuania
facility: Research Site
city: Lodz
country: Poland
facility: Research Site
state: 90-153
city: Bialystok
country: Poland
facility: Research Site
city: Ciechanow
country: Poland
facility: Research Site
city: Golub Dobrzyn
country: Poland
facility: Research Site
city: Grodzisk Mazowiecki
country: Poland
facility: Research Site
city: Katowice
country: Poland
facility: Research Site
city: Krakow
country: Poland
facility: Research Site
city: Makow Mazowiecki
country: Poland
facility: Research Site
city: Radom
country: Poland
facility: Research Site
city: Szczecin
country: Poland
facility: Research Site
city: Warszawa
country: Poland
facility: Research Site
city: Wroclaw
country: Poland
facility: Research Site
city: Zabrze
country: Poland
facility: Research Site
city: Satu-mare
country: Romania
facility: Research Site
state: Satu Mare
city: Bacau
country: Romania
facility: Research Site
city: Brasov
country: Romania
facility: Research Site
city: Bucharest
country: Romania
facility: Research Site
city: Bucuresti
country: Romania
facility: Research Site
city: Sf Gheorghe
country: Romania
facility: Research Site
city: Chelyabinsk
country: Russian Federation
facility: Research Site
city: Moscow
country: Russian Federation
facility: Research Site
city: Ryazan
country: Russian Federation
facility: Research Site
city: St.petersburg
country: Russian Federation
facility: Research Site
city: Yaroslavl
country: Russian Federation
facility: Research Site
city: Dnipropetrovsk
country: Ukraine
facility: Research Site
city: Ivano-frankivsk
country: Ukraine
facility: Research Site
city: Kharkiv
country: Ukraine
facility: Research Site
city: Kyiv
country: Ukraine
facility: Research Site
city: Mykolayiv
country: Ukraine
facility: Research Site
city: Sumy
country: Ukraine
facility: Research Site
city: Ternopil
country: Ukraine
facility: Research Site
city: Zaporizhzhya
country: Ukraine
facility: Research Site
Study officials:
affiliation: AstraZeneca
name: Peter Ohman, MD, PhD
role: STUDY_DIRECTOR
affiliation: AstraZeneca
name: Deborah Price, MSc
role: STUDY_CHAIR
References:
citation: 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.