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Remission Evaluation of a Metabolic Intervention in Type 2 Diabetes With Sitagliptin (REMIT-Sita)

NCT02623998 · Status: COMPLETED · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 102

Last updated 2022-03-25

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 of sitagliptin, 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

sitagliptin/metformin

Dose is titrated to 50/1000 mg bid 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

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
2016-07-09
Primary Completion
2018-09-01
Completion
2019-11-30

Countries

  • Canada

Study Locations

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Entities

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 NCT02623998 on ClinicalTrials.gov