Skip Navigation
Skip to contents

Diabetes Metab J : Diabetes & Metabolism Journal

Search
OPEN ACCESS

Search

Page Path
HOME > Search
2 "Pragmatic clinical trial"
Filter
Filter
Article category
Keywords
Publication year
Authors
Funded articles
Original Articles
Drug/Regimen
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
Jae Hyun Bae, Chang Ho Ahn, Ye Seul Yang, Sun Joon Moon, Soo Heon Kwak, Hye Seung Jung, Kyong Soo Park, Young Min Cho
Diabetes Metab J. 2022;46(1):71-80.   Published online June 16, 2021
DOI: https://doi.org/10.4093/dmj.2020.0274
  • 7,861 View
  • 432 Download
  • 1 Web of Science
  • 3 Crossref
Graphical AbstractGraphical Abstract AbstractAbstract PDFSupplementary MaterialPubReader   ePub   
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).

Citations

Citations to this article as recorded by  
  • Basal insulin titration algorithms in patients with type 2 diabetes: the simplest is the best (?)
    V.I. Katerenchuk
    INTERNATIONAL JOURNAL OF ENDOCRINOLOGY (Ukraine).2023; 19(1): 72.     CrossRef
  • Issues of insulin therapy for type 2 diabetes and ways to solve them
    V.I. Katerenchuk, A.V. Katerenchuk
    INTERNATIONAL JOURNAL OF ENDOCRINOLOGY (Ukraine).2023; 19(3): 240.     CrossRef
  • Time for Using Machine Learning for Dose Guidance in Titration of People With Type 2 Diabetes? A Systematic Review of Basal Insulin Dose Guidance
    Camilla Heisel Nyholm Thomsen, Stine Hangaard, Thomas Kronborg, Peter Vestergaard, Ole Hejlesen, Morten Hasselstrøm Jensen
    Journal of Diabetes Science and Technology.2022; : 193229682211459.     CrossRef
Clinical Care/Education
Insulin Initiation in Insulin-Naïve Korean Type 2 Diabetic Patients Inadequately Controlled on Oral Antidiabetic Drugs in Real-World Practice: The Modality of Insulin Treatment Evaluation Study
Sang Soo Kim, In Joo Kim, Yong Ki Kim, Kun Ho Yoon, Ho Young Son, Sung Woo Park, Yeon Ah Sung, Hong Sun Baek
Diabetes Metab J. 2015;39(6):481-488.   Published online November 25, 2015
DOI: https://doi.org/10.4093/dmj.2015.39.6.481
  • 3,948 View
  • 69 Download
  • 9 Web of Science
  • 11 Crossref
AbstractAbstract PDFPubReader   
Background

The Modality of Insulin Treatment Evaluation (MOTIV) study was performed to provide real-world data concerning insulin initiation in Korean type 2 diabetes mellitus (T2DM) patients with inadequate glycemic control with oral hypoglycemic agents (OHAs).

Methods

This multicenter, non-interventional, prospective, observational study enrolled T2DM patients with inadequate glycemic control (glycosylated hemoglobin [HbA1c] ≥7.0%) who had been on OHAs for ≥3 months and were already decided to introduce basal insulin by their physician prior to the start of the study. All treatment decisions were at the physician's discretion to reflect real-world practice.

Results

A total of 9,196 patients were enrolled, and 8,636 patients were included in the analysis (mean duration of diabetes, 8.9 years; mean HbA1c, 9.2%). Basal insulin plus one OHA was the most frequently (51.0%) used regimen. After 6 months of basal insulin treatment, HbA1c decreased to 7.4% and 44.5% of patients reached HbA1c <7%. Body weight increased from 65.2 kg to 65.5 kg, which was not significant. Meanwhile, there was significant increase in the mean daily insulin dose from 16.9 IU at baseline to 24.5 IU at month 6 (P<0.001). Overall, 17.6% of patients experienced at least one hypoglycemic event.

Conclusion

In a real-world setting, the initiation of basal insulin is an effective and well-tolerated treatment option in Korean patients with T2DM who are failing to meet targets with OHA therapy.

Citations

Citations to this article as recorded by  
  • Real-World Outcomes of Individualized Targeted Therapy with Insulin Glargine 300 Units/mL in Insulin-Naïve Korean People with Type 2 Diabetes: TOBE Study
    Eun-Gyoung Hong, Kyung-Wan Min, Jung Soo Lim, Kyu-Jeung Ahn, Chul Woo Ahn, Jae-Myung Yu, Hye Soon Kim, Hyun Jin Kim, Won Kim, Dong Han Kim, Hak Chul Jang
    Advances in Therapy.2024;[Epub]     CrossRef
  • Clinical Evidence and Practice-Based Guidelines on the Utility of Basal Insulin Combined Oral Therapy (Metformin and Glimepiride) in the Current Era
    Abhishek Shrivastava, Jothydev Kesavadev, Viswanathan Mohan, Banshi Saboo, Dina Shrestha, Anuj Maheshwari, Brij Mohan Makkar, Kirtikumar D. Modi, Ashok Kumar Das
    Current Diabetes Reviews.2023;[Epub]     CrossRef
  • Where to Initiate Basal Insulin Therapy: Inpatient or Outpatient Department? Real-World Observation in China
    Minyuan Chen, Puhong Zhang, Yang Zhao, Nadila Duolikun, Linong Ji
    Diabetes, Metabolic Syndrome and Obesity: Targets and Therapy.2022; Volume 15: 3375.     CrossRef
  • Therapeutic Effect of Quadruple Oral Hypoglycemic Agents in Patients with Type 2 Diabetes Mellitus Who Have Insulin Limitations
    Won Sang Yoo, Do Hee Kim, Hee Jin Kim, Hyun Kyung Chung
    The Journal of Korean Diabetes.2019; 20(2): 117.     CrossRef
  • Use of Insulin Glargine 100 U/mL for the Treatment of Type 2 Diabetes Mellitus in East Asians: A Review
    Takahisa Hirose, Ching-Chu Chen, Kyu Jeung Ahn, Jacek Kiljański
    Diabetes Therapy.2019; 10(3): 805.     CrossRef
  • Nationwide Trends in Pancreatitis and Pancreatic Cancer Risk Among Patients With Newly Diagnosed Type 2 Diabetes Receiving Dipeptidyl Peptidase 4 Inhibitors
    Minyoung Lee, Jiyu Sun, Minkyung Han, Yongin Cho, Ji-Yeon Lee, Chung Mo Nam, Eun Seok Kang
    Diabetes Care.2019; 42(11): 2057.     CrossRef
  • Insulin therapy for adult patients with type 2 diabetes mellitus: a position statement of the Korean Diabetes Association, 2017
    Byung-Wan Lee, Jin Hwa Kim, Seung-Hyun Ko, Kyu Yeon Hur, Nan-Hee Kim, Sang Youl Rhee, Hyun Jin Kim, Min Kyong Moon, Seok-O Park, Kyung Mook Choi
    The Korean Journal of Internal Medicine.2017; 32(6): 967.     CrossRef
  • Insulin Therapy for Adult Patients with Type 2 Diabetes Mellitus: A Position Statement of the Korean Diabetes Association, 2017
    Byung-Wan Lee, Jin Hwa Kim, Seung-Hyun Ko, Kyu-Yeon Hur, Nan-Hee Kim, Sang Youl Rhee, Hyun Jin Kim, Min Kyong Moon, Seok-O Park, Kyung Mook Choi
    Diabetes & Metabolism Journal.2017; 41(5): 367.     CrossRef
  • Effectiveness of Vildagliptin in Clinical Practice: Pooled Analysis of Three Korean Observational Studies (the VICTORY Study)
    Sunghwan Suh, Sun Ok Song, Jae Hyeon Kim, Hyungjin Cho, Woo Je Lee, Byung-Wan Lee
    Journal of Diabetes Research.2017; 2017: 1.     CrossRef
  • Comparison of Antidiabetic Regimens in Patients with Type 2 Diabetes Uncontrolled by Combination Therapy of Sulfonylurea and Metformin: Results of the MOHAS Disease Registry in Korea
    Sung Hee Choi, Tae Jung Oh, Hak Chul Jang
    Diabetes & Metabolism Journal.2017; 41(3): 170.     CrossRef
  • Instauration d’une insulinothérapie chez le patient diabétique de type 2 en médecine générale : Comparaison de l’étude belge InsuStar avec quelques études françaises et internationales
    A.-J. Scheen
    Médecine des Maladies Métaboliques.2016; 10(4): 334.     CrossRef

Diabetes Metab J : Diabetes & Metabolism Journal