Clinical inertia in basal insulin-treated patients with type 2 diabetes – Results from a retrospective database study in Japan (JDDM 43)

Abstract

AimsThis retrospective cohort study investigated whether clinical inertia, the failure to intensify treatment when required, exists in Japanese clinical practice, using the CoDiC® database. How and when patients with type 2 diabetes treated with basal insulin received treatment intensification was also described.Materials and methodsPatients with type 2 diabetes who initiated basal insulin between 2004 and 2011 were eligible for inclusion. Patients with an HbA1c ≥7.0% (≥53.0 mmol/mol) after 180 days of basal insulin titration were eligible for intensification, and their treatment was followed for up to 1.5 years. Endpoints were time to intensification, changes in HbA1c, and insulin dose.ResultsOverall, 2351 patients initiated basal insulin treatment (mean HbA1c 9.4% [79.2 mmol/mol]), and 1279 patients were eligible for treatment intensification (HbA1c ≥7.0% [≥53.0 mmol/mol]) after the 180-day titration period. During the 1.5-year follow-up period (beyond the 180-day titration period), 270 (21%) of these patients received treatment intensification. In patients receiving treatment intensification, mean HbA1c decreased from 8.6 to 8.2% (70.5 to 66.1 mmol/mol) at end of follow-up. Treatment was intensified using bolus insulin in 126 (47%) patients and with premixed insulin in 144 (53%) patients. The estimated probability of intensifying treatment during the 12 months after recording HbA1c ≥7.0% (≥53.0 mmol/mol) was 22.8%, and 27.5% after 17 months. Mean end-of-follow-up daily insulin dose was 35.11 units for basal–bolus compared with 20.70 units for premix therapy.ConclusionsThis study suggests clinical inertia exists in basal insulin-treated patients with type 2 diabetes in Japan. Strategies are needed to increase the number of patients undergoing therapy intensification and to reduce the delay in intensification in Japan.

Fixed‐ratio combination of basal insulin and glucagon‐like peptide‐1 receptor agonists in the treatment of Japanese people with type 2 diabetes: An innovative solution to a complex therapeutic challenge

“…Moreover, because of the associated risk of hypoglycaemia and weight gain, 44,45 BB therapy is difficult for most people with T2D to maintain outside of hospitals without ongoing medical support, resulting in de‐escalation of therapy in many cases. In the JDDM 43 retrospective cohort study, among Japanese people with T2D who had intensified BI with BB or premixed therapy, mean HbA1c was 8.2% after 17 months 46 ; therefore, insulin intensification with such therapies is not sufficient to provide glycaemic control in many people with T2D.…”

Clinical inertia is the enemy of therapeutic success in the management of diabetes and its complications: a narrative literature review

“…Independently of large regional variation, widespread delay of insulin initiation has been reported also in other Countries from Central and South-Eastern Europe [41,42]. Finally, a retrospective cohort study investigating whether clinical inertia existed also in Japanese clinical practice, demonstrated that the estimated probability of intensifying treatment during the 12 months after recording HbA1c ≥ 7.0% (≥ 53.0 mmol/mol) was only 22.8%, and 27.5% after 17 months, evidence of clinical inertia in basal insulin-treated patients with type 2 diabetes in Japan [43].…”

“…Percentage of therapy intensification in patients with HBA1c > 8% (addition of an oral hypoglycemic agent or dosage increase for an existing therapy or initiation of insulin treatment) [33,83] Percentage of therapy intensification in patients with HBA1c > 7% [84] Percentage of initiation of insulin treatment in patients with HBa1c > 9% [42] Average time elapsed between type 2 diabetes diagnosis and initiation of insulin treatment in patients with non-target HBa1c [42] Percentage of patients with HBa1c > 7% undergoing basal insulin treatment for 180 days and subjected to the intensification of insulin therapy [43] Difference between the percentage of outpatient visits in which sBP was higher than the target minus the percentage of outpatient visits in which a modification of anti-hypertensive treatment was implemented, either type or dose of treatment, divided by the number of eligible visits. The resulting value is multiplied by the average difference between sBP as measured in all visits and the target value of sBP [85] Percentage of patients with non-target levels of LDL cholesterol and treated with statins, divided by the total number of eligible patients [86] Time (days) elapsed before a therapeutic intervention subsequent to sub-optimal lab test results [87] Percentage of healthcare professionals who prescribe the initiation of insulin therapy to patients with type 2 diabetes and HbA1c at the recommended threshold of 7-7.9% [42] Number of patients without therapy intensification, divided by the total number of patients with HbA1c ≥ 7%, multiplied by 100 [52] Time spent with poor glycemic control (HbA1c 7%, > 7,5%, > 8%) in patients with type 2 diabetes treated with DPP-4i/SGLT-2i until the intensification of treatment with insulin/GLP-1RA [88] Percentage of patients lacking therapy intensification within 180 days from metformin failure [89] through a methodology equated with the use of outcome indicators (Table 3).…”

Superior HbA1c control with the fixed‐ratio combination of insulin degludec and liraglutide (IDegLira) compared with a maximum dose of 50 units of insulin degludec in Japanese individuals with type 2 diabetes in a phase 3, double‐blind, randomized trial

“…Basal or pre‐mix insulin, in combination with oral agents such as metformin, are established treatments for T2D in Japan . However, many patients fail to achieve adequate glycaemic control and, therefore, may be at higher risk of developing long‐term complications, possibly as a result of clinical inertia …”

“…7 However, many patients fail to achieve adequate glycaemic control and, therefore, may be at higher risk of developing long-term complications, 8 possibly as a result of clinical inertia. 9 Barriers to optimal initiation and titration of insulin can include the increased risk of hypoglycaemia and weight gain, as well as the burden of the number of injections necessary to titrate and administer complex insulin regimens that is experienced by patients. 10 To help overcome some of these barriers, combination therapy with basal insulin and a glucagon-like peptide-1 receptor agonist (GLP-1RA), administered as separate injections, has been recommended by the Japanese Diabetes Society following successful outcomes from recent global trials.…”