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
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Jae Hyun Bae, Chang Ho Ahn, Ye Seul Yang, Sun Joon Moon, Soo Heon Kwak, Hye Seung Jung, Kyong Soo Park, Young Min Cho
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Diabetes Metab J. 2022;46(1):71-80. Published online June 16, 2021
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DOI: https://doi.org/10.4093/dmj.2020.0274
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Graphical Abstract
Abstract
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- 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).
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Citations
Citations to this article as recorded by
- 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.2024; 18(5): 1185. CrossRef - Comparative efficacy and safety of weekly tirzepatide versus weekly insulin in type 2 diabetes: A network meta‐analysis of randomized clinical trials
Hazem Ayesh, Sajida Suhail, Suhail Ayesh, Kevin Niswender
Diabetes, Obesity and Metabolism.2024; 26(9): 3801. CrossRef - 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
- Clinical Diabetes & Therapeutics
- Effectiveness and Safety of Adding Basal Insulin Glargine in Patients with Type 2 Diabetes Mellitus Exhibiting Inadequate Response to Metformin and DPP-4 Inhibitors with or without Sulfonylurea
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Yu Mi Kang, Chang Hee Jung, Seung-Hwan Lee, Sang-Wook Kim, Kee-Ho Song, Sin Gon Kim, Jae Hyeon Kim, Young Min Cho, Tae Sun Park, Bon Jeong Ku, Gwanpyo Koh, Dol Mi Kim, Byung-Wan Lee, Joong-Yeol Park
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Diabetes Metab J. 2019;43(4):432-446. Published online June 19, 2019
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DOI: https://doi.org/10.4093/dmj.2018.0092
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6,431
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Abstract
PDFSupplementary MaterialPubReader
- Background
We aimed to investigate the effectiveness and safety of adding basal insulin to initiating dipeptidyl peptidase-4 (DPP-4) inhibitor and metformin and/or sulfonylurea (SU) in achieving the target glycosylated hemoglobin (HbA1c) in patients with type 2 diabetes mellitus (T2DM).
MethodsThis was a single-arm, multicenter, 24-week, open-label, phase 4 study in patients with inadequately controlled (HbA1c ≥7.5%) T2DM despite the use of DPP-4 inhibitor and metformin. A total of 108 patients received insulin glargine while continuing oral antidiabetic drugs (OADs). The primary efficacy endpoint was the percentage of subjects achieving HbA1c ≤7.0%. Other glycemic profiles were also evaluated, and the safety endpoints were adverse events (AEs) and hypoglycemia.
ResultsThe median HbA1c at baseline (8.9%; range, 7.5% to 11.1%) decreased to 7.6% (5.5% to 11.7%) at 24 weeks. Overall, 31.7% subjects (n=33) achieved the target HbA1c level of ≤7.0%. The mean differences in body weight and fasting plasma glucose were 1.2±3.4 kg and 56.0±49.8 mg/dL, respectively. Hypoglycemia was reported in 36 subjects (33.3%, 112 episodes), all of which were fully recovered. There was no serious AE attributed to insulin glargine. Body weight change was significantly different between SU users and nonusers (1.5±2.5 kg vs. −0.9±6.0 kg, P=0.011).
ConclusionThe combination add-on therapy of insulin glargine, on metformin and DPP-4 inhibitors with or without SU was safe and efficient in reducing HbA1c levels and thus, is a preferable option in managing T2DM patients exhibiting dysglycemia despite the use of OADs.
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Citations
Citations to this article as recorded by
- Glycaemic control with add‐on thiazolidinedione or a sodium‐glucose co‐transporter‐2 inhibitor in patients with type 2 diabetes after the failure of an oral triple antidiabetic regimen: A 24‐week, randomized controlled trial
Jaehyun Bae, Ji Hye Huh, Minyoung Lee, Yong‐Ho Lee, Byung‐Wan Lee
Diabetes, Obesity and Metabolism.2021; 23(2): 609. CrossRef - Beneficial effect of anti-diabetic drugs for nonalcoholic fatty liver disease
Kyung-Soo Kim, Byung-Wan Lee
Clinical and Molecular Hepatology.2020; 26(4): 430. CrossRef
- Clinical Care/Education
- Practical Focus on American Diabetes Association/European Association for the Study of Diabetes Consensus Algorithm in Patients with Type 2 Diabetes Mellitus: Timely Insulin Initiation and Titration (Iran-AFECT)
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Mohammad Ebrahim Khamseh, Gholamreza Yousefzadeh, Zahra Banazadeh, Sahar Ghareh
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Diabetes Metab J. 2017;41(1):31-37. Published online October 25, 2016
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DOI: https://doi.org/10.4093/dmj.2017.41.1.31
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Abstract
PDFPubReader
- Background
The aim of this study was to evaluate the safety and effectiveness of insulin glargine in a large population from a variety of clinical care in Iranian people with type 2 diabetes mellitus (T2DM) and to measure the percentage of patients achieving glycosylated hemoglobin (HbA1c) <7% by the end of 24 weeks of treatment in routine clinical practice.
Methods This study was a 24 week, observational study of patients with T2DM, for whom the physician had decided to initiate or to switch to insulin glargine. The safety and efficacy of glargine were assessed at baseline and at week 24.
ResultsSeven hundred and twenty-five people with T2DM (63% female) including both insulin naïve and prior insulin users were recruited in this study. The mean age of the participants was 54.2±11.2 years, and the mean HbA1c level was 8.88%±0.93% at baseline. By the end of the study, 27% of the entire participants reached to HbA1c target of less than 7% and 52% had HbA1c ≤7.5%. No serious adverse event was reported in this study. Furthermore, overall hypoglycemia did not increase in prior insulin users and the entire cohort. In addition, body weight did not change in participants while lipid profile improved significantly.
ConclusionTreatment with insulin glargine could improve glycemic control without increasing the risk of hypoglycemic events in people with T2DM. In addition, a significant clinical improvement was observed in lipid profile.
- Therapeutic Efficacy of Combined Therapy with Once Daily Insulin Glargine and Once Daily Glimepiride in Korean Type 2 Diabetic Patients.
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Ji Young Park, Hyo Jeong Kim, Bo Kyung Koo, Hyun Jin Kim, Gang Seo Pak, Kyung Ah Han, Kyung Wan Min, Eung Jin Kim
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Korean Diabetes J. 2007;31(5):391-401. Published online September 1, 2007
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DOI: https://doi.org/10.4093/jkda.2007.31.5.391
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Abstract
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- BACKGROUND
Once daily injection and 24 hour lasting glucose lowering effect of insulin glargine had recently changed a perception about the early insulin treatment of type 2 diabetic patients. This study was performed to investigate therapeutic efficacy of combined therapy with insulin glargine and glimepiride in Korean type 2 diabetic patients, who had received oral hypoglycemic agents (OHA) or conventional insulin therapy. METHODS: Total of 192 patients who needed to change the previous therapy because of uncontrolled diabetes or hypoglycemia were included and followed for about 6 months. Two groups of prior treatment modality were analyzed; OHA group (n = 54, 28.1%), conventional insulin therapy group in combination with or without OHA group (n = 138, 71.9%). The primary end point was changes in HbA1c according to baseline characteristics such as prior treatment modality, HbA1C, c-peptide, duration of diabetes mellitus, body mass index and prior used conventional insulin doses. Secondary end point was the dose conversion ratio of insulin glargine to prior used insulin in patients who had one or two insulin therapy. We also evaluated the level of the patients' satisfaction on the glucose lowering effects and the convenience for use of device. RESULTS: The differences of HbA1c according to prior treatment groups were -0.78 +/- 1.76 % in OHA group and 0.07 +/- 1.44 % in conventional insulin group with or without OHA group. The HbA1c improved better when baseline HbA1c was higher than 9%, c-peptide was higher than 0.6 ng/mL, duration of diabetes was shorter than 15 years, BMI was lower than 30 kg/m2 and prior conventional insulin dose was less than 30 IU. However, those effects were attenuated in subjects having duration of diabetes longer than 16 years, BMI higher than 30 kg/m2 and prior insulin dose more than 40 IU. Dose conversion ratio of the insulin glargine to prior insulin was 0.78 +/- 0.30 and showed a tendency to increase in patients who have prior insulin dose more than 40 IU. The scores of the patients' subjective satisfaction on insulin glargine were all high, irrespective of the changes of HbA1c. CONCLUSIONS: Once daily injection of insulin glargine and oral ingestion of glimepiride can be recommended as one of starting insulin regimen for patients who are not adequately controlled by OHA alone or as once daily regimen for whom treated with one or two conventional insulin therapy.
Randomized Controlled Trial
- Short-term Therapeutic Efficacy of Different Oral Hypoglycemic Agents Combined with Once Daily Insulin Glargine in Type 2 Diabetic Subjects with Failure of Sulfonylurea and Metformin Combination.
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Seong Il Hong, Hyeong Jin Kim, Jong Myon Bae, Sun Ok Song, Kyung Suk Park, Byung Soo Jeon, Seun Duk Hwang, Jin Yi Choi, Jeong Hun Kim, Hyuk Jin Kwon, Ja Sung Choi, Myoung Lyeol Woo, Ji Hoon Cho, Young Jun Won
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Korean Diabetes J. 2007;31(4):336-342. Published online July 1, 2007
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DOI: https://doi.org/10.4093/jkda.2007.31.4.336
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Abstract
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- Backgroud: Although the extended duration of action of insulin glargine supports a convenient once daily injection, the combination with other short acting insulins or oral hypoglycemic agents is required to control postprandial hyperglycemia in type 2 diabetes. The present study was designed to compare the short-term therapeutic efficacy of oral hypoglycemic agents with once daily insulin glargine, switching from a multiple daily injection regimen. METHODS: After control with the intensive regimen (daily lispro insulin and glargine) during 5~7 days, 80 in-patients with type 2 diabetes were randomized and treated with four oral hypoglycemic agents (glimepiride 4 mg qd, metformin 500 mg bid, nateglinide 90 mg tid, or acarbose 100 mg tid) plus once daily insulin glargine during 5 days. Blood glucose concentration was recorded by seven daily estimations (before each meal, 2 hours after each meal, and bedtime). Blood glucose concentrations and area under the curves (AUCs) of blood glucose were compared among four groups. RESULTS: The area under the curve of blood glucose of metformin, glimepiride, nateglinide, and acarbose groups were 165.5 +/- 46.0, 178.5 +/- 36.5, 209.9 +/- 55.1, and 224.9 +/- 55.8 mmol/L/hr respectively. Blood glucose concentrations and area under the curves of blood glucose of glimepiride and metformin groups were significantly lower than those of acarbose group. Also, those of metformin group were significantly lower than those of nateglinide group. Conclusions: Metformin or glimepiride are more effective oral hypoglycemic agent than nateglinide or acarbose in the combination with insulin glargine in type 2 diabetic subjects with failure of sulfonylurea and metformin combination.