Trial intelligence / Profile preview

Saxagliptin on Retinal Endothelial Function (ESENDI)

NCT01319357Phase 3

Key facts

Status
Completed
Start
Oct 2010
Primary completion
Apr 2013
Countries
1
Sponsor
FAU Erlangen-Nürnberg Medical Faculty
Conditions
type 2 diabetes mellitus (T2DM)
01

Overview

Phase 3, randomised, double-blind trial of saxagliptin in type 2 diabetes mellitus (T2DM), sponsored by FAU Erlangen-Nürnberg Medical Faculty. Started Oct 2010; status: completed.

02

Design

Study design
RandomizedDouble-blind
03

Who it enrols

Adults with type 2 diabetes mellitus (HbA1c 6.5-11%) without diabetic retinopathy or recent cardiovascular events.

04

Registry description

Diabetes mellitus is a metabolic disease with a growing prevalence worldwide. Currently available therapies for type 2 diabetes have various limitations and are associated with increased risk of hypoglycemia, weight gain, gastrointestinal side effects or edema and heart failure.

A new and promising class of drugs are the gliptins. Several efficacy studies demonstrated a significant improvement of HbA1c with gliptins. In addition, gliptins improved fasting as well as prandial glucose levels and did not induce weight gain. Due to these positive metabolic effects in combination with a very…

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