The Durability of Basal Insulin Affects Day-to-Day Glycemic Variability Assessed by Continuous Glucose Monitoring in Type 2 Diabetes Patients: A Randomized Crossover Trial

Iuchi, Hiroyuki; Sakamoto, Masaya; Matsutani, Daisuke; Suzuki, Hirofumi; Horiuchi, Ryô; Utsunomiya, Kazunori

doi:10.1089/dia.2017.0028

Cited by 11 publications

(9 citation statements)

References 23 publications

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“…It is assumed that 3 to 4 days are needed to achieve steady state conditions for insulin glargine U300 . Iuchi et al showed reduced glycaemic variability when comparing insulin glargine U300 and insulin glargine U100 after a 4‐week titration period (CV, 26.8% vs 25.3%) . In our study, CV was 36.1% on Day 1 compared to 31.4% on Day 4 and 28.9% on Day 7 of titration, thus showing comparable glycaemic variability for insulin glargine U300 even early in the titration phase.…”

Section: Discussionsupporting

confidence: 60%

GlucoTab‐guided insulin therapy using insulin glargine U300 enables glycaemic control with low risk of hypoglycaemia in hospitalized patients with type 2 diabetes

Aberer

Lichtenegger

Smajic

et al. 2018

Diabetes Obesity Metabolism

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Aims To investigate efficacy, safety and usability of the GlucoTab system for glycaemic management using insulin glargine U300 in non‐critically ill hospitalized patients with type 2 diabetes (T2D). Materials and Methods In this open, non‐controlled single‐arm pilot study, glycaemic control at the general ward of a tertiary care hospital was guided by a mobile decision support system (GlucoTab) for basal‐bolus insulin dosing using the novel basal insulin analogue insulin glargine U300 for the first time. Glycaemic control was surveilled with capillary glucose measurements and continuous glucose monitoring (CGM). The primary endpoint was efficacy of glycaemic management, defined as the percentage of blood glucose measurements within the target range of 3.9 to 7.8 mmol/L. Results A total of 30 patients with T2D (12 female; age, 67 ± 11 years; HbA1c, 70 ± 26 mmol/mol; BMI, 31.8 ± 5.6 kg/m 2 ; length of study, 8.5 ± 4.5 days) were included. In total, 894 capillary glucose values and 49 846 data points of CGM were available, of which 56.1% of all measured capillary glucose values and 54.3% of CGM values were within the target area (3.9‐7.8 mmol/L). Overall capillary mean glucose was 8.5 ± 1.2 and 8.4 ± 1.2 mmol/L assessed by CGM. Time within glucose target improved continuously during the course of treatment, while time within hypoglycaemia (<3.9 mmol/L) decreased substantially. The GlucoTab‐suggested total daily dose was accepted by staff in 97.3% of situations. Conclusions Treatment with GlucoTab using insulin glargine U300 in hospitalized patients with T2D is effective and safe.

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Section: Discussionsupporting

confidence: 60%

GlucoTab‐guided insulin therapy using insulin glargine U300 enables glycaemic control with low risk of hypoglycaemia in hospitalized patients with type 2 diabetes

Aberer

Lichtenegger

Smajic

et al. 2018

Diabetes Obesity Metabolism

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“…In addition, we have also routinely observed intermediate-term GV caused by differences in the duration of drug actions due to differences in half-life and other factors. We also reported such differences in our clinical trials using insulin [ 36 ]. Intermediate-term GV is also useful in determining the effects of the duration of action of medications and other factors.…”

Section: Intermediate-term Glycemic Variabilitymentioning

confidence: 82%

Type 2 Diabetes and Glycemic Variability: Various Parameters in Clinical Practice

Sakamoto

2018

J Clin Med Res

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It has become possible to measure blood glucose levels continuously from 24 h to approximately 2 weeks due to the recent development of relevant devices such as continuous glucose monitoring and flash glucose monitoring systems. This has enabled not only medical professionals but also patients to monitor details of glycemic variability (GV) which was not possible in the past. Details of GV for both short and intermediate periods can now be obtained, and it is important in patient care to appropriately evaluate the data obtained. Types of GV in terms of time frame vary from short-term to long-term. Several studies reported that long-term GV was related to micro- and macro-angiopathies in patients with type 2 diabetes mellitus (T2DM). However, there are still unknown aspects regarding the relationships of various durations of GV with prognosis. Further clinical trials are required to examine the mechanism of GV and to evaluate whether GV can be a valuable therapeutic target in treatment of patients with T2DM.

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“…It has been reported that IGlar U300 is as effective for glycemic control as IGlar U100 and superior in reducing hypoglycemia according to phase 3 clinical trials performed as multi-center, open-label, and parallel-group studies [ 3–13 ]. The daily blood glucose variability assessed using continuous glucose monitoring (CGM) system was also improved by IGlar 300 treatment compared with IGlar 100 in patients with types 1 [ 17 ] and 2 diabetes [ 18 ]. Because IGlar biosimilar has an identical amino acid sequence and the same pharmaceutical form as IGlar [ 1 ], both IGlar biosimilar and IGlar U100 demonstrated similar glucose control with similar safety profiles in patients with types 1 and 2 diabetes [ 19–21 ].…”

Section: Discussionmentioning

confidence: 99%

A comparison of the clinical courses of type 2 diabetic patients whose basal insulin preparation was replaced from insulin glargine 100 units/mL to insulin glargine biosimilar or 300 units/mL: a propensity score-matched observation study

Itoh

Tsugami

Ando

et al. 2018

Journal of Drug Assessment

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Objective: We compared the clinical course of type 2 diabetic patients whose basal insulin preparations were replaced from insulin glargine (IGlar) 100 units/mL (U100) to IGlar biosimilar or IGlar 300 units/mL (U300).Methods: After propensity score matching, 34 patients whose basal insulin preparation was switched from IGlar U100 to IGlar biosimilar and 102 switched to IGlar U300 were observed for 6 months.Results: The HbA1c level and body weight did not change significantly after the replacement in the IGlar biosimilar or IGlar U300 groups. In the IGlar biosimilar group, the frequency of subjects who experienced hypoglycemia after the replacement (12%) was not different from before (12%). However, the frequency was significantly lower after the replacement (2%) than before (13%) in the IGlar U300 group. The change in the HbA1c level after the replacement showed a significant association with the HbA1c level at the baseline but not with the kind of IGlar. Hypoglycemia was frequently observed in subjects who had experienced hypoglycemia before the replacement.Conclusions: IGlar biosimilar and IGlar U300 induced similar HbA1c and body weight changes among type 2 diabetic patients. IGlar biosimilar is a suitable option for patients with a low risk for hypoglycemia.

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The Durability of Basal Insulin Affects Day-to-Day Glycemic Variability Assessed by Continuous Glucose Monitoring in Type 2 Diabetes Patients: A Randomized Crossover Trial

Abstract: Compared with glargine U100 treatment, glargine U300 treatment improved the MODD as assessed by CGM in type 2 diabetes patients. These findings suggest that the durability of basal insulin may be associated with day-to-day glycemic variability in type 2 diabetes patients.

Cited by 11 publications

References 23 publications

GlucoTab‐guided insulin therapy using insulin glargine U300 enables glycaemic control with low risk of hypoglycaemia in hospitalized patients with type 2 diabetes

GlucoTab‐guided insulin therapy using insulin glargine U300 enables glycaemic control with low risk of hypoglycaemia in hospitalized patients with type 2 diabetes

Type 2 Diabetes and Glycemic Variability: Various Parameters in Clinical Practice

A comparison of the clinical courses of type 2 diabetic patients whose basal insulin preparation was replaced from insulin glargine 100 units/mL to insulin glargine biosimilar or 300 units/mL: a propensity score-matched observation study

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