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

NACompletedINTERVENTIONAL
Enrollment

130

Participants

Timeline

Start Date

October 1, 2017

Primary Completion Date

January 17, 2020

Study Completion Date

July 14, 2020

Conditions
Type 2 Diabetes Mellitus
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"

Trial Locations (1)

110-744

Seoul National University Hospital, Seoul

Sponsors

Collaborators (1)

All Listed Sponsors
collaborator

Sanofi

INDUSTRY

lead

Seoul National University Hospital

OTHER

NCT03406663 - The Korean TITRATION Study: Comparison of the Self-titration Methods for Glargine-300 | Biotech Hunter | Biotech Hunter