Remission Evaluation of a Metabolic Intervention for Type 2 Diabetes With IGlarLixi

NCT03130426 · Completed

Last updated 2026-05-28

This clinical trial is testing whether a combination of insulin and a diabetes medication (IGlarLixi) can help people with type 2 diabetes stay in remission without their blood sugar levels rising again.

Status Completed The study has finished.

Phase Phase 3 Confirms effectiveness in a large group before approval.

Type Interventional (clinical trial)

Design Randomized, open-label (no blinding) treatment study

Participants 161 people

Who can join Ages 30–80 · all sexes

Timeline Started 2017-06 · est. completion 2020-09

Where 8 sites · Canada

What this study is testing ClinicalTrials.gov NCT03130426 ↗

Description as written by the study sponsor.

The purpose of the study is to determine whether in patients with early type 2 diabetes, a short-term intensive metabolic intervention comprising iGlarLixi, metformin, and lifestyle approaches will be superior to standard diabetes therapy in achieving sustained diabetes remission.

Treatments tested

iGlarLixi also known as glargine insulin / lixisenatide Drug

Dose is titrated to achieve fasting normoglycemia
Insulin Glargine also known as Lantus Drug

In those who need additional insulin or who cannot tolerate iGlarLixi, insulin glargine will be used. Dose is titrated to achieve fasting normoglycemia.
Metformin Drug

Dose is titrated to 2000 mg daily or maximal tolerated dose
Lifestyle therapy also known as diet and exercise Behavioral

Lifestyle intervention includes individualized dietary and exercise advice and frequent visits for goal reinforcement, behavior modification and problem-solving

Main thing measured	The first occurrence of diabetes relapse
Sponsor	Population Health Research Institute
Conditions studied	Type 2 Diabetes Mellitus
GLP-1 drugs	—

Full protocol, eligibility, and contacts on ClinicalTrials.gov NCT03130426 ↗