Diabetes Metab J.  2022 Jan;46(1):71-80. 10.4093/dmj.2020.0274.

Efficacy and Safety of Self-Titration Algorithms of Insulin Glargine 300 units/mL in Individuals with Uncontrolled Type 2 Diabetes Mellitus (The Korean TITRATION Study): A Randomized Controlled Trial

• Bae JH
• Ahn CH
• Yang YS
• Moon SJ
• Kwak SH
• Jung HS
• Park KS
• Cho YM

• KMID: 2525127
• DOI: http://doi.org/10.4093/dmj.2020.0274

Abstract

Background
To compare the efficacy and safety of two insulin self-titration algorithms, Implementing New Strategies with Insulin Glargine for Hyperglycemia Treatment (INSIGHT) and EDITION, for insulin glargine 300 units/mL (Gla-300) in Korean individuals with uncontrolled type 2 diabetes mellitus (T2DM).
Methods
In a 12-week, randomized, open-label trial, individuals with uncontrolled T2DM requiring basal insulin were randomized to either the INSIGHT (adjusted by 1 unit/day) or EDITION (adjusted by 3 units/week) algorithm to achieve a fasting self-monitoring of blood glucose (SMBG) in the range of 4.4 to 5.6 mmol/L. The primary outcome was the proportion of individuals achieving a fasting SMBG ≤5.6 mmol/L without noct urnal hypoglycemia at week 12.
Results
Of 129 individuals (age, 64.1±9.5 years; 66 [51.2%] women), 65 and 64 were randomized to the INSIGHT and EDITION algorithms, respectively. The primary outcome of achievement was comparable between the two groups (24.6% vs. 23.4%, P=0.876). Compared with the EDITION group, the INSIGHT group had a greater reduction in 7-point SMBG but a similar decrease in fasting plasma glucose and glycosylated hemoglobin. The increment of total daily insulin dose was significantly higher in the INSIGHT group than in the EDITION group (between-group difference: 5.8±2.7 units/day, P=0.033). However, body weight was significantly increased only in the EDITION group (0.6±2.4 kg, P=0.038). There was no difference in the occurrence of hypoglycemia between the two groups. Patient satisfaction was significantly increased in the INSIGHT group (P=0.014).
Conclusion
The self-titration of Gla-300 using the INSIGHT algorithm was effective and safe compared with that using the EDITION algorithm in Korean individuals with uncontrolled T2DM (ClinicalTrials.gov number: NCT03406663).

Keyword

Algorithms; Blood glucose self-monitoring; Diabetes mellitus, type 2; Hypoglycemia; Insulin glargine; Patient satisfaction; Pragmatic clinical trial; Randomized controlled trial

Figure

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  Fig. 1. Study design. The participants were randomly assigned to either the Implementing New Strategies with Insulin Glargine for Hyperglycemia Treatment (INSIGHT) or EDITION group and self-titrated the dose of insulin glargine 300 units/mL according to each algorithm for 12 weeks. NIAHA, noninsulin antihyperglycemic agents; NPH, neutral protamine Hagedorn; SMBG, self-monitoring of blood glucose. aIn group 2, one individual was excluded owing to the withdrawal of informed consent.

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  Fig. 2. The proportion of individuals with type 2 diabetes mellitus achieving a fasting self-monitoring of blood glucose value ≤5.6 mmol/L without hypoglycemia at week 12. Data are presented as proportion (%). The analysis was performed according to the intention-to-treat principle (n=129). P values <0.05 were regarded as statistically significant. INSIGHT, Implementing New Strategies with Insulin Glargine for Hyperglycemia Treatment.

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  Fig. 3. Changes in (A) 7-point self-monitoring of blood glucose (SMBG) values and (B) the area under the curve (AUC) from week 0 to week 12. Data are presented as mean and standard error of the mean. The analysis was performed according to the intention-to-treat principle (n=129). P values <0.05 were regarded as statistically significant. INSIGHT, Implementing New Strategies with Insulin Glargine for Hyperglycemia Treatment. There was a significant decrease in SMBG levels from week 0 to week 12 in athe abovementioned groups and the bINSIGHT group.

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  Fig. 4. Changes in (A) total daily insulin dose (TDD) and (B) body weight from week 0 to week 12. Data are presented as mean and standard error of the mean. The analysis was performed according to the intention-to-treat principle (n=129). P values <0.05 were regarded as statistically significant. INSIGHT, Implementing New Strategies with Insulin Glargine for Hyperglycemia Treatment.

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