Cross-sectional survey in patients with type 1 and type 2 diabetes to understand mealtime insulin unmet needs in Japan: The MINUTES-J study

Ishii, Hitoshi; Suzuki, Shuichi; Williams, Paul; Demiya, S.; Aranishi, Toshihiko; Treuer, Tamás

doi:10.1016/j.diabres.2020.108076

Cited by 6 publications

(11 citation statements)

References 25 publications

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“…This finding reflects the fast onset and short duration of action observed in URLi clinical pharmacology studies [26,27]. As described LS least squares, N number of subjects in the population with baseline and post-baseline value at the specified timepoint, n number of subjects with hypoglycemia, SE standard error, URLi ultra-rapid lispro * p \ 0.05 for comparison of mealtime URLi to lispro earlier, many patients inject mealtime insulin after the start of a meal as a result of various inevitable reasons [22]. In addition, injecting URLi 15 min after a meal led to lower PPG excursions compared to injecting lispro 15 min after a meal [28].…”

Section: Discussionmentioning

confidence: 99%

“…This finding reflects the fast onset and short duration of action observed in URLi clinical pharmacology studies [ 26 , 27 ]. As described earlier, many patients inject mealtime insulin after the start of a meal as a result of various inevitable reasons [ 22 ]. In addition, injecting URLi 15 min after a meal led to lower PPG excursions compared to injecting lispro 15 min after a meal [ 28 ].…”

Section: Discussionmentioning

confidence: 99%

“…This pivotal study demonstrated that URLi was non-inferior to lispro for change in HbA1c following 26 weeks of treatment [21]. In a recent survey, Japanese patients with diabetes reported moderate to severe burden in multiple aspects of their lives associated with current mealtime insulin timing [22]. Specifically, 8.9% of patients reported that their normal mealtime insulin injection timing was after the start of a meal in the past month.…”

Section: Introductionmentioning

confidence: 98%

“…Specifically, 8.9% of patients reported that their normal mealtime insulin injection timing was after the start of a meal in the past month. Also, the average percentage of time that patients inject after the start of a meal in the past month was 11.0% [22]. The main reasons for dosing during or after a meal were lifestyle-related, such as eating or working outside of home, or not being able to find a suitable place to inject [22,23].…”

Section: Introductionmentioning

confidence: 99%

“…Also, the average percentage of time that patients inject after the start of a meal in the past month was 11.0% [22]. The main reasons for dosing during or after a meal were lifestyle-related, such as eating or working outside of home, or not being able to find a suitable place to inject [22,23]. Unlike the USA and Europe, there are limited rapid-acting insulins approved for postmeal administration in Japan, and none were approved at the time this study commenced.…”

Section: Introductionmentioning

confidence: 99%

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Ultra-Rapid Lispro Efficacy and Safety Compared to Humalog® in Japanese Patients with Type 1 Diabetes: PRONTO-T1D Subpopulation Analysis

et al. 2020

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Introduction: We evaluated the efficacy and safety of ultra-rapid lispro (URLi) in comparison to lispro in a subgroup analysis of Japanese adults with type 1 diabetes mellitus from the phase 3 PRONTO-T1D trial. Methods: After an 8-week lead-in to optimize basal insulin treatment, patients were randomized to 52-week double-blind mealtime URLi or lispro, or 26-week open-label postmeal URLi. The primary endpoint was change in hemoglobin A1c (HbA1c) from baseline (week 0) to week 26 between mealtime URLi and lispro. The multiplicity adjusted objectives were 1-and 2-h postprandial glucose (PPG) excursions after a meal test between mealtime URLi and lispro, and change in HbA1c from baseline to week 26 between postmeal URLi and mealtime lispro. Results: This manuscript presents pre-specified exploratory analyses of 26-week data from Japanese patients randomized to double-blind URLi (n = 62) or lispro (n = 59), or open-label URLi (n = 46). Mean baseline HbA1c levels were 7.52% for mealtime URLi, 7.44% for lispro, and 7.51% for postmeal URLi at randomization. At week 26, the least squares mean (LSM) difference compared to lispro was 0.04% (95% confidence interval [CI]-0.14 to 0.22) for mealtime URLi, and 0.16% (95% CI-0.04 to 0.35) for postmeal URLi. In comparison to lispro, mealtime URLi resulted in statistically significantly lower 1-and 2-h PPG excursions during the mixed-meal tolerance test. LSM differences were-40.5 mg/dL, 95% CI-59.5 to 21.4 (-2.25 mmol/L, 95% CI-3.3 to-1.2) for 1-h PPG excursions and-51.7 mg/dL, 95% CI-81.7 to-21.8 (-2.87 mmol/L, 95% CI-4.5 to-1.2) for 2-h PPG excursions at week 26. There were no significant treatment differences in rates of severe/ overall hypoglycemia, or incidence of treatment-emergent adverse events. Conclusions: Mealtime and postmeal URLi provide effective and comparable glycemic control in Japanese patients. Mealtime URLi demonstrated more effective PPG control compared to lispro. Trial Registration: ClinicalTrials.gov, NCT032 14367.

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Section: Discussionmentioning

confidence: 99%

Section: Discussionmentioning

confidence: 99%

Section: Introductionmentioning

confidence: 98%

Section: Introductionmentioning

confidence: 99%

Section: Introductionmentioning

confidence: 99%

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Ultra-Rapid Lispro Efficacy and Safety Compared to Humalog® in Japanese Patients with Type 1 Diabetes: PRONTO-T1D Subpopulation Analysis

et al. 2020

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Long-term Efficacy and Safety of Ultra Rapid Lispro in Japanese Patients With Type 1 Diabetes: Subpopulation Analysis of the 52-Week PRONTO-T1D Study

2021

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Introduction The PRONTO-T1D study evaluated the efficacy and safety of ultra rapid lispro (URLi) versus lispro in adults with type 1 diabetes mellitus. After 26 weeks of treatment, mealtime and postmeal URLi provided effective and comparable glycemic control in a prespecified subpopulation analysis of Japanese patients from PRONTO-T1D. We present the results of a 52-week study which evaluated the long-term efficacy and safety of URLi in Japanese patients. Methods After an 8-week lead-in period to optimize basal insulin treatment, Japanese patients were randomized to one of three treatment groups: the 52-week double-blind mealtime URLi ( n = 62) or mealtime lispro ( n = 59) group, respectively, or the 52-week open-label postmeal URLi ( n = 46) group. Results At week 52, there were no statistically significant differences in change from baseline in hemoglobin A1c (HbA1c) between Japanese patients on URLi and those on lispro; the least-squares mean (LSM) treatment difference was 0.04% (95% confidence interval [CI] − 0.18, 0.25) between mealtime URLi and lispro, and 0.04% (95% CI − 0.19, 0.28) between postmeal URLi and mealtime lispro. No significant between-group differences were observed in the number of patients achieving the HbA1c target of < 7.0% (20.0, 30.5 and 16.3% of those on mealtime URLi, mealtime lispro and postmeal URLi, respectively). Daily average blood glucose levels in the 10-point self-monitored blood glucose profiles at week 52 were similar between treatments. However, compared with lispro, lower blood glucose levels were observed for the mealtime URLi group at the morning 1- and 2-h postmeal time points with LSM differences of − 32.7 mg/dL (− 1.82 mmol/L) ( p = 0.005) and − 23.2 mg/dL (− 1.29 mmol/L) ( p = 0.029), respectively. There were no significant treatment differences in the incidences of treatment-emergent adverse events, documented hypoglycemia and severe hypoglycemia; however, the rate of documented hypoglycemia was lower in the mealtime URLi arm compared with the lispro arm. Conclusions Overall glycemic control and improved postprandial glucose via self-monitoring was maintained in Japanese patients following 52 weeks of treatment with URLi versus lispro, including postmeal URLi administration. Trial Registration ClinicalTrials.gov: NCT03214367. Supplementary Information The online version contains supplementary material available at 10.1007/s13300-021-01124-9.

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The Burden and Impacts of Mealtime Insulin from the Perspective of People with Diabetes

et al. 2023

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Introduction While there have been continued advances in insulin treatment for diabetes since the discovery of insulin 100 years ago, some unmet needs still remain, including those related to mealtime insulin (MTI). The objective of this study was to explore the impacts related to MTI and the relative burden of the impacts on people with diabetes. Methods This study was conducted across two phases, namely, a qualitative and quantitative phase. People with type 1 and 2 diabetes using MTI in the USA and UK were recruited for the study. The qualitative phase involved 30 interviews to explore the impacts associated with MTI. Based on the results of the qualitative phase, a list of impacts was developed to evaluate the importance of MTI impacts using best−worst scaling. Results A total of 30 participants completed interviews, and 336 completed the quantitative phase. Participants described a range of impacts associated with MTI, including psychological (72.0%), social (63.0%), work/school (53.8%), and sleep (51.7%). Impacts for the quantitative phase were categorized under the following domains: diabetes distress, diabetes management, work productivity, and social. The three most burdensome impacts were related to diabetes distress, but the diabetes management domain contributed more than diabetes distress to the relative burden. There were minor differences in the relative importance of impacts by diabetes type, diabetes duration, and experience with continuous glucose monitoring. Conclusion This study confirms that people with diabetes using MTI still have an array of unmet needs, including those related to the management of their diabetes and the emotional distress of having diabetes. These findings may be useful for healthcare provider (HCP)-patient interactions to ensure HCPs are allowing patients an opportunity to discuss their experiences with MTI. Supplementary Information The online version contains supplementary material available at 10.1007/s13300-023-01405-5.

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Cross-sectional survey in patients with type 1 and type 2 diabetes to understand mealtime insulin unmet needs in Japan: The MINUTES-J study

Cited by 6 publications

References 25 publications

Ultra-Rapid Lispro Efficacy and Safety Compared to Humalog® in Japanese Patients with Type 1 Diabetes: PRONTO-T1D Subpopulation Analysis

Ultra-Rapid Lispro Efficacy and Safety Compared to Humalog® in Japanese Patients with Type 1 Diabetes: PRONTO-T1D Subpopulation Analysis

Long-term Efficacy and Safety of Ultra Rapid Lispro in Japanese Patients With Type 1 Diabetes: Subpopulation Analysis of the 52-Week PRONTO-T1D Study

The Burden and Impacts of Mealtime Insulin from the Perspective of People with Diabetes

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