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Research

Photo for REMIT-iGlarLixi

REMIT-iGlarLixi

Official Title

Remission Evaluation of a Metabolic Intervention in Type 2 Diabetes with IGlarLixi (REMIT IGlarLixi)

Status

Ongoing

Overview

To determine if in patients with recently-diagnosed T2DM, a 12-week course of iGlarLixi (combined basal insulin glargine and lixisenatide), metformin, and lifestyle approaches will achieve drug-free diabetes remission in a higher proportion of patients than standard diabetes therapy at 24 weeks (3 months after the drugs are stopped). Participants will be randomized to 2 treatment groups: (a) a 12-week course of treatment with iGLarLixi, metformin, and lifestyle therapy, and (b) standard diabetes therapy, and followed for a total of 64 weeks.

Study Design

This is a multicentre, open-label, randomized controlled trial in patients with recently-diagnosed T2DM.

Primary Endpoint

The primary outcome in this trial will be diabetes remission evaluated at 24 weeks after randomization.

Number of Patients

160

Number of Sites

8

Number of Countries

1

Study Period

2017-2020

Principal Investigator

Natalia McInnes, Hertzel Gerstein

Program Manager

Tara McCready

Research Coordinator

Stephanie Hall

Collaborators

Sanofi

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