An interventional study of Group 1 and Group 2 in Type 2 Diabetes Mellitus, sponsored by Seoul National University Hospital. Completed at 1 site in Korea, Republic of. Open to participants aged 19 Years and older. Per ClinicalTrials.gov, last updated 2020-10-22.
Sponsored by Seoul National University Hospital · Not applicable, Interventional, and Treatment
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.
The primary objective of this study is to obtain efficacy and safety descriptive data on two different titration algorithms: the INSIGHT titration algorithm (self-titration of 1 unit/day) and the EDITION trial algorithm with insulin glargine 300 units/mL (GLA-300) when given as basal insulin in uncontrolled T2DM patients on basal insulin with or without non-insulin anti-hyperglycemic agent (NIAHA) or in insulin naïve patients.
In a Korean, single-center, type 2 diabetes patients with basal insulin therapy will be enrolled. They will be randomly assigned to either titration algorithm for GLA-300. After 12 weeks, the glycemic control, patients' satisfaction to the titration methods and healthcare providers' satisfaction to titration methods will be assessed.
Exclusion Criteria:
In group 1, the dose of Gla-300 will be titrated by the patients by 1 unit per day until achieving a fasting SMPG in the target range of 4.4 to 5.6 mmol/L (INSIGHT algorithm). Titration algorithms: 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 1. ≥ 5.6 mmol/L, increase 1 unit of Gla-300 dose 2. \> 4.4 and ≤ 5.6 mmol/L, no change 3. \< 4.4 mmol/L, reduce 1 unit of Gla-300 dose
Behavioral: Group 1
In group 2, the dose of Gla-300 will be titrated by the patients based on the SMPG values of the last 3 days at least weekly, but no more often than every 3 days to achieve a fasting SMPG in the target range of 4.4 to 5.6 mmol/L (EDITION algorithm). Fasting SMPG (median of the last 3 days including current day) in the range of 1. ≥ 7.8 mmol/L, increase 6 units of Gla-300 dose 2. \> 5.6 and \< 7.8 mmol/L, increase 3 units of Gla-300 dose 3. \> 4.4 and ≤ 5.6 mmol/L, no change 4. ≥ 3.3 and \< 4.4 mmol/L, reduce 3 units of Gla-300 dose 5. \< 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
Behavioral: Group 2
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
Also known as: INSIGHT algorithm
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
Also known as: EDITION algorithm
Proportion of patients achieving fasting SMPG ≤ 5.6 mmol/L without hypoglycemia at 12 weeks
Time frame: up to 12 weeks
Changes in HbA1c (%)
Time frame: up to 12 weeks
Fasting plasma glucose (mmol/L)
Time frame: up to 12 weeks
Fasting SMPG (mmol/L)
Time frame: up to 12 weeks
7-point SMPG (mmol/L)
Time frame: up to 12 weeks
Proportion of patients at HbA1c ≤ 7%
Time frame: up to 12 weeks
Change in insulin dose (IU)
Time frame: up to 12 weeks
Change in body weight (kilogram)
Time frame: up to 12 weeks
Hypoglycemia (number of patients)
Time frame: up to 12 weeks
Adverse events
Time frame: up to 12 weeks
Patient satisfaction to the insulin titration method (evaluated by prespecified questionnaire: DTSQs)
Time frame: up to 12 weeks
Health care professionals' satisfaction to the insulin titration methods (evaluated by prespecirfied questionnaire: health care provider treatment satisfaction questionnaire)
Time frame: up to 12 weeks
This study is completed, as verified in Oct 2020. You cannot join it, but the record below documents what was studied.
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Seoul National University Hospital