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Clinical Trial Details

Trial ID: L2136
Source ID: NCT02917031
Associated Drug: Saxagliptin
Title: Mechanistic Evaluation of Glucose-lowering Strategies in Patients With Heart Failure
Acronym: MEASURE-HF
Status: COMPLETED
Study Results: YES
Results: https://ClinicalTrials.gov/show/NCT02917031/results
Conditions: Type 2 Diabetes Mellitus|Heart Failure
Interventions: DRUG: Saxagliptin|DRUG: Sitagliptin|DRUG: Placebo to match saxagliptin|DRUG: Placebo to match sitagliptin
Outcome Measures: Primary: Change From Baseline in Left Ventricular End Diastolic Volume (LVEDV) Index Measured by Magnetic Resonance Imaging (MRI) at 24 Weeks, MRI was performed to evaluate LVEDV at baseline and Visit 10 (Week 24). Evaluated to exclude an increase in left ventricular end diastolic volume (LVEDV) index of greater than 10% of the overall baseline value (noninferiority margin) in patients with T2DM and HF treated with saxagliptin for 24 weeks, compared to placebo. Baseline is last assessment on or before the date of first dose., Baseline to 24 weeks | Secondary: Change From Baseline in Left Ventricular End Systolic Volume (LVESV) Index, Measured by MRI at 24 Weeks., Evaluation of the effects of saxagliptin compared to placebo on left ventricular end systolic volume (LVESV) index, after 24 weeks in patients with T2DM and HF., Baseline to week 24|Change From Baseline in Left Ventricular Ejection Fraction (LVEF) Measured by MRI at 24 Weeks., Evaluation the effects of saxagliptin compared to placebo on left ventricular end systolic volume (LVESV) index, left ventricular ejection fraction (LVEF), and left ventricular mass (LVM) after 24 weeks in patients with T2DM and HF., Baseline to week 24|Change From Baseline in Left Ventricular Mass (LVM) Measured by MRI at 24 Weeks., Evaluation of the effects of saxagliptin compared to placebo on left ventricular mass (LVM) after 24 weeks in patients with T2DM and HF., At 24 week|Change From Baseline in NT-proBNP After 24 Weeks of Treatment, Evaluation of the effects of saxagliptin compared to placebo on N-terminal prohormone of brain natriuretic peptide (NT-proBNP) after 24 weeks of treatment., Baseline to Week 28 (End of Study visit [EoS])|Number of Participants With Adverse Events, Assessment of safety and tolerability of saxagliptin and sitagliptin treatment in patients with T2DM and HF, From screening (Days -28 to -1) until Week 28 (follow-up visit)
Sponsor/Collaborators: Sponsor: AstraZeneca
Gender: ALL
Age: ADULT, OLDER_ADULT
Phases: PHASE4
Enrollment: 348
Study Type: INTERVENTIONAL
Study Designs: Allocation: RANDOMIZED|Intervention Model: PARALLEL|Masking: TRIPLE (PARTICIPANT, CARE_PROVIDER, INVESTIGATOR)|Primary Purpose: TREATMENT
Start Date: 2017-01-10
Completion Date: 2019-08-23
Results First Posted: 2021-06-18
Last Update Posted: 2021-11-08
Locations: Research Site, Torrance, California, 90502, United States|Research Site, Upland, California, 91786, United States|Research Site, Miami, Florida, 33133, United States|Research Site, Ormond Beach, Florida, 32174, United States|Research Site, Chicago, Illinois, 60610, United States|Research Site, Bronx, New York, 10455, United States|Research Site, Bronx, New York, 10459, United States|Research Site, Sayre, Pennsylvania, 18840, United States|Research Site, Spartanburg, South Carolina, 29302, United States|Research Site, Houston, Texas, 77089, United States|Research Site, Milwaukee, Wisconsin, 64111, United States|Research Site, Sofia, 1142, Bulgaria|Research Site, Sofia, 1431, Bulgaria|Research Site, Sofia, 1606, Bulgaria|Research Site, Sofia, 1618, Bulgaria|Research Site, Sofia, 1784, Bulgaria|Research Site, Chicoutimi, Quebec, G7H 7K9, Canada|Research Site, Santiago, 8207257, Chile|Research Site, Santiago, 8360160, Chile|Research Site, Santiago, 8380453, Chile|Research Site, Santiago, 8910259, Chile|Research Site, Talcahuano, 4270918, Chile|Research Site, Viña del Mar, 2520997, Chile|Research Site, Balatonfüred, 8230, Hungary|Research Site, Budapest, 1122, Hungary|Research Site, Budapest, 1134, Hungary|Research Site, Budapest, 1171, Hungary|Research Site, Debrecen, 4032, Hungary|Research Site, Hajdúszoboszló, 4200, Hungary|Research Site, Kecskemét, 6000, Hungary|Research Site, Kisvárda, 4600, Hungary|Research Site, Nyíregyháza, 4400, Hungary|Research Site, Orosháza, 5900, Hungary|Research Site, Pécs, 7623, Hungary|Research Site, Székesfehérvár, 8000, Hungary|Research Site, Busan, 49241, Korea, Republic of|Research Site, Daejeon, 35015, Korea, Republic of|Research Site, Gwangju, 61469, Korea, Republic of|Research Site, Hwaseong-si, 18450, Korea, Republic of|Research Site, Seongnam-si, 13620, Korea, Republic of|Research Site, Seoul, 02841, Korea, Republic of|Research Site, Seoul, 03080, Korea, Republic of|Research Site, Seoul, 03722, Korea, Republic of|Research Site, Wonju-si, 26426, Korea, Republic of|Research Site, Brasov, 500365, Romania|Research Site, Iasi, 700304, Romania|Research Site, Iasi, 700515, Romania|Research Site, Izhevsk, 426035, Russian Federation|Research Site, Kemerovo, 650002, Russian Federation|Research Site, Moscow, 109263, Russian Federation|Research Site, Moscow, 115516, Russian Federation|Research Site, Moscow, 121551, Russian Federation|Research Site, Nizhnii Novgorod, 603018, Russian Federation|Research Site, Novosibirsk, 630055, Russian Federation|Research Site, Novosibirsk, 630087, Russian Federation|Research Site, Novosibirsk, 630089, Russian Federation|Research Site, Saint-Petersburg, 194354, Russian Federation|Research Site, Saint-Petersburg, 199226, Russian Federation|Research Site, St Petersburg, 197341, Russian Federation|Research Site, Tomsk, 634012, Russian Federation|Research Site, Tomsk, 634050, Russian Federation|Research Site, Yaroslavl, 150062, Russian Federation|Research Site, Bangkoknoi, 10700, Thailand|Research Site, Bangkok, 10330, Thailand|Research Site, Bangkok, 10400, Thailand|Research Site, Chiang Mai, 50200, Thailand|Research Site, Khon Kaen, 40002, Thailand|Research Site, Ivano-Frankivsk, 76005, Ukraine|Research Site, Ivano-Frankivsk, 76018, Ukraine|Research Site, Kyiv, 02091, Ukraine|Research Site, Kyiv, 02660, Ukraine|Research Site, Kyiv, 03680, Ukraine|Research Site, Lviv, 79015, Ukraine|Research Site, Rivne, 33007, Ukraine
URL: https://clinicaltrials.gov/show/NCT02917031

Drug ID Drug Name Type DrugBank ID Targets Category Latest Progress
D447 Saxagliptin small molecule DB06335 Details