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REMIT-iDegLira

Official Title

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

Status

Ongoing

Overview

Participants who have been recently-diagnosed with T2DM will be randomized to two treatment groups: (a) a 16-week period of lifestyle coaching support, metformin and a once-daily injection of IDegLira, and (b) standard diabetes therapy, and followed for a total of 68 weeks (1 year and 4 months). In all participants with HbA1C<7.3% at the 16 week visit, glucose-lowering medications will be discontinued and participants will be encouraged to continue with lifestyle modifications and regular glucose monitoring. Participants with HbA1C ≥ 7.3% at this visit or whose HbA1C is ≥ 7.0% at or after the 28 week visit will receive standard glycemic management. The primary outcome is drug-free diabetes remission defined as a HbA1c <6.5% without use of glucose-lowering agents for at least 12 weeks.

Study Design

Multicentre, open-label, randomized controlled trial

Number of Patients

160

Number of Sites

10

Number of Countries

1

Study Period

2019-2021

Principal Investigator

Hertzel Gerstein, Zubin Punthakee

Program Manager

Tara McCready

Research Coordinator

Stephanie Hall