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Clinical Trial Details

Trial ID: L4958
Source ID: NCT02406443
Associated Drug: Sitaglitpin
Title: The INDORSE Study: Inhibition of Dipeptidyl Peptidase IV: Outcomes on Renal Sodium Excretion
Acronym: INDORSE
Status: COMPLETED
Study Results: YES
Results: https://ClinicalTrials.gov/show/NCT02406443/results
Conditions: Type 2 Diabetes
Interventions: DRUG: Sitaglitpin|OTHER: Placebo
Outcome Measures: Primary: Percent Change in Fractional Excretion of Sodium (FENA), FENA at 3Hrs post-study drug administration after 1 month compared to FENA at 3Hrs post-study drug administration after 1 dose expressed as percent change, sitagliptin vs. placebo, 3 Hrs post-administration after 1 month and after 1 dose | Secondary: Change in Glomerular Filtration Rate (GFR), Measured GFR (Inulin Clearance) at 3Hrs post study-drug after 1 month compared to Measured GFR at 3Hrs post-study drug after 1 dose, sitagliptin vs. placebo, 3 Hrs post-administration after 1 month and after 1 dose|Change in Fractional Excretion of Lithium (FELi), FELi at 3 Hr post-study drug administration after 1 month compared to FELI at 3hrs post-study drug administration after 1 dose, sitagliptin vs. placebo, 3 Hrs post-administration after 1 month and after 1 dose|Change From Baseline in SDF-1alpha^1-67 (Intact) Measured by Immunoaffinity and Tandem Mass Spectrometry, Plasma concentration of SDF-1alpha\^1-67 (intact) measured by quantitative mass spectrometry methods after antibody-based affinity enrichment, sitagliptin vs. placebo, 3 Hr vs. baseline after 1 dose|Change From Baseline in SDF-1alpha^3-67 (Truncated) Measured by Tandem Mass Spectrometry With Antibody-based Affinity Enrichment, Plasma concentration of SDF-1alpha\^3-67 (intact) measured by quantitative mass spectrometry methods after antibody-based affinity enrichment, sitagliptin vs. placebo, 3Hrs vs baseline after 1 dose|Change in Systolic Blood Pressure (SBP), Non-invasive Cardiac Output Monitoring, SBP by Non-Invasive cardiac output monitoring at 3Hrs post- study drug administration after 1 month compared to SBP by Non-invasive cardiac output monitoring at 3Hrs after 1 dose, sitagliptin vs placebo, 3 Hrs post-administration after 1 month and after 1 dose|Change in Effective Renal Plasma Flow (ERPF), ERPF (para-aminohippurate clearance) 3Hrs post-study drug administration after 1 month compared to ERPF at 3Hhrs post-study drug administration after 1 dose, sitagliptin vs placebo, 3 Hrs post-administration after 1 month and after 1 dose
Sponsor/Collaborators: Sponsor: University Health Network, Toronto | Collaborators: Merck Sharp & Dohme LLC
Gender: ALL
Age: ADULT, OLDER_ADULT
Phases: PHASE4
Enrollment: 36
Study Type: INTERVENTIONAL
Study Designs: Allocation: RANDOMIZED|Intervention Model: PARALLEL|Masking: TRIPLE (PARTICIPANT, INVESTIGATOR, OUTCOMES_ASSESSOR)|Primary Purpose: OTHER
Start Date: 2015-03
Completion Date: 2017-01
Results First Posted: 2018-04-05
Last Update Posted: 2018-04-05
Locations: University Health Network - Division of Nephrology, Toronto, Ontario, M5G 2N2, Canada
URL: https://clinicaltrials.gov/show/NCT02406443