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

NCT02561130 · Status: COMPLETED · Phase: PHASE4 · Type: INTERVENTIONAL · Enrollment: 154

Last updated 2020-11-24

Study results available
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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.

Conditions

Interventions

DRUG

insulin glargine

Dose is titrated to achieve fasting normoglycemia

DRUG

metformin

Dose is titrated to 1 g bid or maximal tolerated dose

DRUG

Forxiga

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

BEHAVIORAL

Lifestyle therapy

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

Sponsors & Collaborators

  • AstraZeneca

    collaborator INDUSTRY

  • Population Health Research Institute

    lead OTHER

Principal Investigators

  • Natalia McInnes, MD · McMaster University

  • Hertzel C Gerstein, MD · Hamilton Health Sciences Corporation

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
30 Years
Max Age
80 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2015-12-31
Primary Completion
2017-07-31
Completion
2018-12-31

Countries

  • Canada

Study Locations

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Entities

Drugs
Diseases
Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT02561130 on ClinicalTrials.gov