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Remission Evaluation of a Metabolic Intervention in Type 2 Diabetes With Forxiga

2015-09-29 07:58:39 | BioPortfolio

Summary

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

Description

This is a multicentre, open-label, randomized controlled trial in 152 patients with recently-diagnosed T2DM. Participants will be randomized to 2 treatment groups: (a) a 12-week course of treatment with Forxiga, metformin, insulin glargine and lifestyle therapy, and (b) standard diabetes therapy, and followed for a total of 64 weeks (1 year and 3 months). In all participants with HbA1C<7.3% at the 12 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 24 week visit will receive standard glycemic management as informed by the 2013 Canadian Diabetes Association clinical practice guidelines.

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Conditions

Type 2 Diabetes Mellitus

Intervention

insulin glargine, Metformin, Forxiga, Lifestyle therapy

Status

Not yet recruiting

Source

Population Health Research Institute

Results (where available)

View Results

Links

Published on BioPortfolio: 2015-09-29T07:58:39-0400

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