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

NCT03130426 · Status: COMPLETED · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 161

Last updated 2020-11-13

No results posted yet for this study

Summary

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.

Conditions

Interventions

DRUG

iGlarLixi

Dose is titrated to achieve fasting normoglycemia

DRUG

Insulin Glargine

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

DRUG

Metformin

Dose is titrated to 2000 mg daily or maximal tolerated dose

BEHAVIORAL

Lifestyle therapy

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

Sponsors & Collaborators

  • Sanofi

    collaborator INDUSTRY

  • Population Health Research Institute

    lead OTHER

Principal Investigators

  • Natalia McInnes, MD · McMaster University

  • Hertzel Gerstein, MD · McMaster University

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
30 Years
Max Age
80 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2017-06-27
Primary Completion
2019-06-30
Completion
2020-09-30

Countries

  • Canada

Study Locations

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Entities

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT03130426 on ClinicalTrials.gov