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.