Trial intelligence / Profile preview

Effect of Liraglutide on Angiogenesis in Type 2 Diabetes

NCT02686177Phase 4

Key facts

Status: Completed
Start: May 2016
Primary completion: Aug 2017
Countries: 1
Sponsor: Assistance publique - Hôpitaux de Paris
Modality: Peptides

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

Overview

Phase 4, randomised, open-label trial of liraglutide in type 2 diabetes mellitus (T2DM) (2 arms), sponsored by Assistance publique - Hôpitaux de Paris. Primary endpoint: Difference of Angiopoietin-like 4 concentration at 4 weeks. Started May 2016; status: completed.

Design

2 arms

Study design: RandomizedOpen-label

Liraglutide
Liraglutide 1.2 mg daily + Background
Control
Metformin or Sulfonylurea (Standard Care)

Who it enrols

Adult patients with Type 2 Diabetes, BMI >= 25, and HbA1c > 6.5% on Metformin and/or secretagogues. Excludes patients with recent incretin use, severe renal failure, recent CV events, pancreatitis history, or untreated cancer.

Endpoints

Primary

Difference of Angiopoietin-like 4 concentration4 weeks

Secondary

Difference of Angiopoietin-2 concentration4 weeks
Difference of endothelial circulating progenitor cells concentration4 weeks
Difference of AngiomiR-126 expression4 weeks
Difference of Circulating soluble adhesion molecules4 weeks

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