The INDORSE Study: Inhibition of Dipeptidyl Peptidase IV: Outcomes on Renal Sodium Excretion
Status:
Completed
Trial end date:
2017-01-01
Target enrollment:
Participant gender:
Summary
Background: Dedicated renal hemodynamic and renal function studies are lacking for DPP-4
inhibitors in patients with Type 2 diabetes; accordingly little is known regarding the
mechanisms mediating the renal effects of DPP-4 inhibitors in humans.
Objectives: To evaluate the effect of DPP-4 inhibition acutely (single dose) and following
short-term therapy (28 days) on renal sodium handling and renal hemodynamics and function in
patients with type 2 diabetes and systolic hypertension.
Design: double-blind, randomized, placebo-controlled trial, Phase IV.
Patient population: 32 patients with Type 2 diabetes, HbA1c (6.5%-9%), with systolic blood
pressure ranging from 120-160 mmHg.
Intervention: subjects will be randomized (1:1) to either sitagliptin (100 mg daily) or to
placebo (1 tablet daily) for 28 days.
Endpoints: Fractional excretion of sodium, renal function, and renal hemodynamics.
Phase:
Phase 4
Details
Lead Sponsor:
University Health Network, Toronto
Collaborator:
Merck Sharp & Dohme Corp.
Treatments:
Dipeptidyl-Peptidase IV Inhibitors Sitagliptin Phosphate