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

NCT03862716 · Status: COMPLETED · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 159

Last updated 2023-10-25

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 IDegLira, metformin, and lifestyle approaches will be superior to standard diabetes therapy in achieving sustained diabetes remission.

Conditions

Interventions

DRUG

IDegLira

Dose is titrated to achieve fasting normoglycemia

DRUG

insulin degludec

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

DRUG

Metformin

Dose is titrated to 2000 mg per day or maximal tolerated dose

BEHAVIORAL

Lifestyle Therapy

Lifestyle intervention includes individualized dietary and exercise advice targeting at least 5% weight loss with frequent visits and coaching for goal reinforcement, behavior modification and problem-solving

Sponsors & Collaborators

  • Novo Nordisk A/S

    collaborator INDUSTRY

  • Population Health Research Institute

    lead OTHER

Principal Investigators

  • Zubin Punthakee, 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
2019-04-23
Primary Completion
2022-06-15
Completion
2023-07-31

Countries

  • Canada

Study Locations

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Entities

Drugs
Diseases
Companies

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 NCT03862716 on ClinicalTrials.gov