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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.
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 who experience hyperglycemia relapse after stopping drugs will receive standard glycemic management as informed by the current Canadian Diabetes Association clinical practice guidelines.
Age
30 - 80 years
Sex
ALL
Healthy Volunteers
No
University of Calgary
Calgary, Alberta, Canada
Health Science Centre
Winnipeg, Manitoba, Canada
McMaster University
Hamilton, Ontario, Canada
St. Joseph's Hospital
London, Ontario, Canada
Western University
London, Ontario, Canada
LMC
Toronto, Ontario, Canada
St. Michaels's Hospital
Toronto, Ontario, Canada
Start Date
December 1, 2015
Primary Completion Date
July 1, 2017
Completion Date
December 31, 2018
Last Updated
November 24, 2020
154
ACTUAL participants
insulin glargine
DRUG
metformin
DRUG
Forxiga
DRUG
Lifestyle therapy
BEHAVIORAL
Lead Sponsor
Population Health Research Institute
Collaborators
Data Source & Attribution
This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.
Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.
Neither the United States Government nor Clareo Health make any warranties regarding the data. Check ClinicalTrials.gov frequently for updates.
View ClinicalTrials.gov Terms and ConditionsNCT04943861