CI

At a glance

ClinicalIndex Comparison Record
Phase 4Completed· 154 enrolled
Drug / intervention
insulin glargine +3 moredrug
Likely dose
metformin 1 gfrom record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT02561130
NCT02561130Phase 4Completed
CompareCT.gov

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

Population Health Research Institute·interventional·Posted Sep 25, 2015·Updated Nov 24, 2020

In Brief

A Phase 4 clinical trial evaluating insulin glargine, metformin, and 2 other interventions for Type 2 Diabetes Mellitus. Completed, enrolled 154 participants across 7 sites.

Detailed 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.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsType 2 Diabetes Mellitus
CountriesCanada
CollaboratorsAstraZeneca

Timeline

Phase 4CompletedFinished
20162017201820192020202120222023202420252026
First PostedSep 25, 2015
Enrollment StartDec 1, 2015
Primary CompletionJul 1, 2017
Study CompletionDec 31, 2018
TodayJul 2, 2026
Enrollment to primary: 1.6 yearsPosted 10.8 years ago

Interventions

insulin glarginedrug

Dose is titrated to achieve fasting normoglycemia

metformindrug

Dose is titrated to 1 g bid or maximal tolerated dose

Forxigadrug

Dose is titrated to 10 mg po daily or maximal tolerated dose

Lifestyle therapybehavioral

Lifestyle intervention includes individualized dietary and exercise advice and frequent visits for goal reinforcement, behavior modification and problem-solving