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Clinical Trial Details

Trial ID: L3214
Source ID: NCT00614939
Associated Drug: Saxagliptin
Title: Treatment Effect of Saxagliptin Compared With Placebo in Patients With Type 2 Diabetes and Renal Impairment
Acronym:
Status: COMPLETED
Study Results: YES
Results: https://ClinicalTrials.gov/show/NCT00614939/results
Conditions: Type 2 Diabetes
Interventions: DRUG: Saxagliptin|DRUG: Placebo
Outcome Measures: Primary: 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: Absolute Change From Baseline in Fasting Plasma Glucose (FPG) to Week 12 (LOCF)- Moderate Renal Impairment Subgroup, Adjusted\* mean change from baseline in fasting plasma glucose (FPG) achieved with saxagliptin 2.5 mg once daily versus placebo at Week 12 (Full Analysis Set) for the moderate renal impairment subgroup. FPG 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)|Absolute Change From Baseline in Fasting Plasma Glucose (FPG) to Week 12 (LOCF) - Severe Renal Impairment Subgroup, Adjusted\* mean change from baseline in fasting plasma glucose (FPG) achieved with saxagliptin 2.5 mg once daily versus placebo at Week 12 (Full Analysis Set) for the severe renal impairment subgroup. FPG 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)|Absolute Change From Baseline in Fasting Plasma Glucose (FPG) to Week 12 (LOCF) - End-Stage Renal Impairment Subgroup, Adjusted\* mean change from baseline in fasting plasma glucose (FPG) achieved with saxagliptin 2.5 mg once daily versus placebo at Week 12 (Full Analysis Set) for the end-stage renal impairment subgroup. FPG 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)|Absolute Change From Baseline in Fasting Plasma Glucose (FPG) to Week 12 (LOCF) - Moderate Renal Impairment Subgroup, Adjusted\* mean change from baseline in fasting plasma glucose (FPG) achieved with saxagliptin 2.5 mg once daily versus placebo at Week 12 (Full Analysis Set) for the moderate renal impairment subgroup. FPG 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)|Absolute Change From Baseline in Glycosylated Haemoglobin A1c (HbA1c) Level to Week 52, Adjusted\* mean change from baseline in HbA1c achieved with saxagliptin 2.5 mg once daily versus placebo at Week 52 (Full Analysis Set). HbA1c is a continuous measure, the change from baseline for each participant is calculated at the Week 52 value minus the baseline value., Baseline , Week 52|Absolute Change From Baseline in Fasting Plasma Glucose (FPG) to Week 52 - Moderate Renal Impairment Subgroup, Adjusted\* mean change from baseline in fasting plasma glucose (FPG) achieved with saxagliptin 2.5 mg once daily versus placebo at Week 52 (Full Analysis Set) for the moderate renal impairment subgroup. FPG is a continuous measure, the change from baseline for each participant is calculated at the Week 52 value minus the baseline value., Baseline, Week 52|Absolute Change From Baseline in Fasting Plasma Glucose (FPG) to Week 52 - Severe Renal Impairment Subgroup, Adjusted\* mean change from baseline in fasting plasma glucose (FPG) achieved with saxagliptin 2.5 mg once daily versus placebo at Week 52 (Full Analysis Set) for the severe renal impairment subgroup. FPG is a continuous measure, the change from baseline for each participant is calculated at the Week 52 value minus the baseline value., Baseline, Week 52|Absolute Change From Baseline in Fasting Plasma Glucose (FPG) to Week 52 - End-Stage Renal Impairment Subgroup, Adjusted\* mean change from baseline in fasting plasma glucose (FPG) achieved with saxagliptin 2.5 mg once daily versus placebo at Week 52 (Full Analysis Set) for the end-stage renal impairment subgroup. FPG is a continuous measure, the change from baseline for each participant is calculated at the Week 52 value minus the baseline value., Baseline, Week 52|Absolute Change From Baseline in Fasting Plasma Glucose (FPG) to Week 52 - Moderate Renal Impairment Subgroup, Adjusted\* mean change from baseline in fasting plasma glucose (FPG) achieved with saxagliptin 2.5 mg once daily versus placebo at Week 52 (Full Analysis Set) for the moderate renal impairment subgroup. FPG is a continuous measure, the change from baseline for each participant is calculated at the Week 52 value minus the baseline value, Baseline, Week 52
Sponsor/Collaborators: Sponsor: AstraZeneca | Collaborators: Bristol-Myers Squibb
Gender: ALL
Age: ADULT, OLDER_ADULT
Phases: PHASE3
Enrollment: 572
Study Type: INTERVENTIONAL
Study Designs: Allocation: RANDOMIZED|Intervention Model: PARALLEL|Masking: TRIPLE (PARTICIPANT, CARE_PROVIDER, INVESTIGATOR)|Primary Purpose: TREATMENT
Start Date: 2008-01
Completion Date: 2010-03
Results First Posted: 2010-07-07
Last Update Posted: 2011-05-19
Locations: Research Site, Concord, California, United States|Research Site, Sacramento, California, United States|Research Site, Denver, Colorado, United States|Research Site, Topeka, Kansas, United States|Research Site, Baltimore, Maryland, United States|Research Site, Great Falls, Montana, United States|Research Site, Greenville, North Carolina, United States|Research Site, Morehead City, North Carolina, United States|Research Site, Cincinnati, Ohio, United States|Research Site, Corpus Christi, Texas, United States|Research Site, Charleston, West Virginia, United States|Research Site, Brest, Belarus|Research Site, Gomel, Belarus|Research Site, Minsk, Belarus|Research Site, Dimitrovgrad, Bulgaria|Research Site, Sofia, Bulgaria|Research Site, Veliko Tarnovo, Bulgaria|Research Site, Karlovac, Croatia|Research Site, Osijek, Croatia|Research Site, Rijeka, Croatia|Research Site, Split, Croatia|Research Site, Zagreb, Croatia|Research Site, Moravsky Krumlov, Czech Republic|Research Site, Praha 10, Czech Republic|Research Site, Teplice, Czech Republic|Research Site, Usti Nad Labem, Czech Republic|Research Site, Znojmo, Czech Republic|Research Site, Tallinn, Estonia|Research Site, Dieburg, Germany|Research Site, Dusseldorf, Germany|Research Site, Hannover, Germany|Research Site, Heidelberg, Germany|Research Site, Mannheim, Germany|Research Site, Debrecen, Hungary|Research Site, Gyor, Hungary|Research Site, Kalocsa, Hungary|Research Site, Kecskemet, Hungary|Research Site, Zalaegerszeg, Hungary|Research Site, Riga, Latvia|Research Site, Kaunas, Lithuania|Research Site, Klaipeda, Lithuania|Research Site, Panevezys, Lithuania|Research Site, Vilnius, Lithuania|Research Site, Lodz, 90-153, Poland|Research Site, Bialystok, Poland|Research Site, Ciechanow, Poland|Research Site, Golub Dobrzyn, Poland|Research Site, Grodzisk Mazowiecki, Poland|Research Site, Katowice, Poland|Research Site, Krakow, Poland|Research Site, Makow Mazowiecki, Poland|Research Site, Radom, Poland|Research Site, Szczecin, Poland|Research Site, Warszawa, Poland|Research Site, Wroclaw, Poland|Research Site, Zabrze, Poland|Research Site, Satu-mare, Satu Mare, Romania|Research Site, Bacau, Romania|Research Site, Brasov, Romania|Research Site, Bucharest, Romania|Research Site, Bucuresti, Romania|Research Site, Sf Gheorghe, Romania|Research Site, Chelyabinsk, Russian Federation|Research Site, Moscow, Russian Federation|Research Site, Ryazan, Russian Federation|Research Site, St.petersburg, Russian Federation|Research Site, Yaroslavl, Russian Federation|Research Site, Dnipropetrovsk, Ukraine|Research Site, Ivano-frankivsk, Ukraine|Research Site, Kharkiv, Ukraine|Research Site, Kyiv, Ukraine|Research Site, Mykolayiv, Ukraine|Research Site, Sumy, Ukraine|Research Site, Ternopil, Ukraine|Research Site, Zaporizhzhya, Ukraine
URL: https://clinicaltrials.gov/show/NCT00614939