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INDORSE: Sitagliptin renal effects in T2D

NCT02406443Phase 4

Key facts

Status: Completed
Start: Mar 2015
Primary completion: Jun 2016
Countries: 1
Sponsor: University Health Network
Modality: Small Molecules

Drugs: sitagliptin
Conditions: type 2 diabetes mellitus (T2DM)

Overview

Phase 4, randomised, double-blind trial in type 2 diabetes mellitus (T2DM) comparing Sitagliptin with Placebo (2 arms). Primary endpoint: Percent Change in Fractional Excretion of Sodium. Started Mar 2015; status: completed.

Design

2 arms

Study design: RandomizedDouble-blind

Sitagliptin
Sitagliptin 100 mg daily
Placebo
Placebo daily

Who it enrols

Patients with Type 2 Diabetes, HbA1c 6.5-9%, and systolic blood pressure 120-160 mmHg. Excludes Type 1 Diabetes, eGFR <50, significant cardiac/pulmonary/liver disease, and secondary hypertension.

Endpoints

Primary

Percent Change in Fractional Excretion of Sodium3 hours post-dose (Day 28)

Secondary

Change in Glomerular Filtration Rate3 hours post-dose (Day 28)
Change in Fractional Excretion of Lithium3 hours post-dose (Day 28)
Change From Baseline in SDF-1alpha^1-67 (Intact)3 hours post-dose (Day 1)
Change From Baseline in SDF-1alpha^3-67 (Truncated)3 hours post-dose (Day 1)
Change in Systolic Blood Pressure3 hours post-dose (Day 28)
Change in Effective Renal Plasma Flow3 hours post-dose (Day 28)

Results

Primary endpoints met

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