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Research

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REMIT

Official Title

Remission Evaluation of Metabolic Interventions in Type 2 Diabetes

Status

Ongoing

Overview

To determine whether a short-term intensive metabolic intervention comprising lifestyle approaches, oral glucose-lowering agents and long-acting insulin can normalize blood glucose levels in patients with recently diagnosed T2DM

Study Design

Randomized, open label, 3-arm, parallel group design.

Primary Endpoint

There are two primary outcomes in this pilot trial. The first primary outcome is the proportion of participants in the 8-week intervention group and the control group achieving a mean fasting capillary blood glucose ≤ 5.4 mmol/l and a mean 2-hour pc blood glucose ≤ 6.8 mmol/l on two seven-point glucose profiles during the 8th week of treatment. The second primary outcome is the proportion of participants in the 16-week intervention group and the control group achieving a mean fasting capillary blood glucose ≤ 5.4 mmol/l and a mean 2-hour pc blood glucose ≤ 6.8 mmol/l on two seven-point glucose profiles during the 16th week of treatment.

Number of Patients

83

Number of Sites

1

Number of Countries

1

Study Period

2011–2014

Principal Investigator

Natalia Yakubovich, Hertzel Gerstein

Program Manager

Jackie Bosch

Research Coordinator

Stephanie Hall