Phase 4 N=36 Randomized Triple-blind Other

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

Type 2 Diabetes

Bottom Line

View on ClinicalTrials.gov: NCT02406443 ↗

Enrolled (actual)

Serious AEs

8.6%

Results posted

Apr 2018

Primary outcome: Primary: Percent Change in Fractional Excretion of Sodium (FENA) — 41; -5.0 percentage of change — p==0.012

Study Design & Population

Study type: Interventional
Phase: Phase 4
Interventions: Sitaglitpin (Drug); Placebo (Other)
Age: Adult, Older Adult · 18+ yrs
Sex: All
Sponsor: University Health Network, Toronto
Primary completion: Jun 2016

Outcome Measures

Outcome	Result	p-value
PRIMARY Percent Change in Fractional Excretion of Sodium (FENA)	41; -5.0	=0.012 sig
SECONDARY Change in Glomerular Filtration Rate (GFR)	3.9; -1.8	0.40
SECONDARY Change in Fractional Excretion of Lithium (FELi)	29; 7	0.15
SECONDARY Change From Baseline in SDF-1alpha^1-67 (Intact) Measured by Immunoaffinity and Tandem Mass Spectrometry	0.5; 0	<0.001 sig
SECONDARY Change From Baseline in SDF-1alpha^3-67 (Truncated) Measured by Tandem Mass Spectrometry With Antibody-based Affinity Enrichment	-2.0; 0.4	<0.001 sig
SECONDARY Change in Systolic Blood Pressure (SBP), Non-invasive Cardiac Output Monitoring	5.7; 0.0	0.42
SECONDARY Change in Effective Renal Plasma Flow (ERPF)	31.1; -24.7	—

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.

Eligibility 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:
Type 1 Diabetes,
eGFR 161 mmHg, 7) DBP >100 mmHg,
alcohol or substance abuse,
states of secondary hypertension.

View full record on ClinicalTrials.gov →

Data sourced from ClinicalTrials.gov (NCT02406443). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.