Diabetes Metab J. 2022;46(1):71-80.

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.

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제1저자 배재현 · 교신저자 조영민

PMID 34130445 PMC8831820 DOI 10.4093/dmj.2020.0274 IF 8.2 내분비대사내과

소속 (5)

Department of Internal Medicine, Seoul National University Hospital, Seoul National University College of Medicine, Seoul, Korea.
Department of Internal Medicine, Korea University Anam Hospital, Korea University College of Medicine, Seoul, Korea.
Department of Internal Medicine, Seoul National University Bundang Hospital, Seoul National University College of Medicine, Seongnam, Korea.
Department of Internal Medicine, Uijeongbu St. Mary's Hospital, College of Medicine, The Catholic University of Korea, Uijeongbu, Korea.
Department of Internal Medicine, Kangbuk Samsung Hospital, Sungkyunkwan University School of Medicine, Seoul, Korea.

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).

Keywords

AlgorithmsBlood glucose self-monitoringDiabetes mellitus, type 2HypoglycemiaInsulin glarginePatient satisfactionPragmatic clinical trial

Figures

**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.

**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.

**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.

**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.

그림 출처: PubMed Central 공개 논문 (PMC8831820)

Conflict of interest statement

CONFLICTS OF INTEREST . No potential conflict of interest relevant to this article was reported.

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