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The Korean TITRATION Study: Comparison of the Self-titration Methods for Glargine-300

NCT03406663 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 130

Last updated 2020-10-22

No results posted yet for this study

Summary

The aim of this study is to demonstrate efficacy and safety of self-titration algorithm with Gla-300 using the INSIGHT algorithm (once daily by 1 unit) and the EDITION algorithm (once weekly by 3 units) in Korean patients with T2D.

Conditions

Interventions

BEHAVIORAL

Group 1

Patients will be instructed to daily adjust their dose of Gla-300 based on fasting SMPG values. Fasting SMPG will be measured daily by the patient before breakfast and any intake of antihyperglycemic agents. Fasting SMPG in the range of ≥ 5.6 mmol/L, increase 1 unit of Gla-300 dose, \> 4.4 and ≤ 5.6 mmol/L, no change, \< 4.4 mmol/L, reduce 1 unit of Gla-300 dose

BEHAVIORAL

Group 2

Fasting SMPG (median of the last 3 days including current day) in the range of * 7.8 mmol/L, increase 6 units of Gla-300 dose, \> 5.6 and \< 7.8 mmol/L, increase 3 units of Gla-300 dose, \> 4.4 and ≤ 5.6 mmol/L, no change, * 3.3 and \< 4.4 mmol/L, reduce 3 units of Gla-300 dose, \< 3.3 mmol/L or occurrence of ≥ 2 symptomatic or 1 severe hypoglycemic episode in the preceding week, reduce 3 units of Gla-300 dose or at the discretion of the investigator

Sponsors & Collaborators

  • Sanofi

    collaborator INDUSTRY

  • Seoul National University Hospital

    lead OTHER

Principal Investigators

  • Young Min Cho, MD, PhD · Seoul National University Hospital

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
19 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2017-10-01
Primary Completion
2020-01-17
Completion
2020-07-14

Countries

  • South Korea

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 NCT03406663 on ClinicalTrials.gov