Overview

The INDORSE Study: Inhibition of Dipeptidyl Peptidase IV: Outcomes on Renal Sodium Excretion

Status:
Completed
Trial end date:
2017-01-01
Target enrollment:
0
Participant gender:
All
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
Accepts Healthy Volunteers?
No
Details
Lead Sponsor:
University Health Network, Toronto
Collaborator:
Merck Sharp & Dohme Corp.
Treatments:
Dipeptidyl-Peptidase IV Inhibitors
Sitagliptin Phosphate
Criteria
Inclusion Criteria:

- Individuals of 18-70 years of age,

- with Type 2 Diabetes,

- with an HbA1c (6.5%-9%),

- and with a systolic blood pressure (120-160 mmHg).

Exclusion Criteria:

- Individuals with:

1. Type 1 Diabetes,

2. eGFR <50mL/min/1.73m,

3. pregnancy or breast feeding,

4. significant cardiac, pulmonary or liver disease,

5. prior history of pancreatitis, medullary thyroid cancer, multiple endocrine
neoplasia syndromes,

6. SBP >161 mmHg, 7) DBP >100 mmHg,

7. alcohol or substance abuse,

8. states of secondary hypertension.