A global study of the unmet need for glycemic control and predictor factors among patients with type 2 diabetes mellitus who have achieved optimal fasting plasma glucose control on basal insulin

Abstract

BackgroundThis study used data from different sources to identify the extent of the unmet need for postprandial glycemic control in patients with type 2 diabetes mellitus (T2DM) after the initiation of basal insulin therapy in Europe, Asia Pacific, the United States, and Latin America.MethodsDifferent levels of evidence were used as available for each country/region, with data extracted from seven randomized controlled trials (RCTs), three clinical trial registries (CTRs), and three electronic medical record (EMR) databases. Glycemic status was categorized as “well controlled” (glycated hemoglobin [HbA1c] at target [<7%]), “residual hyperglycemia” (fasting plasma glucose [FPG] but not HbA1c at target [FPG <7.2/7.8 mmol/L, <130/140 mg/dL, depending on country‐specific recommendations]), or “uncontrolled” (both FPG and HbA1c above target). Predictor factors were identified from the RCT data set using logistic regression analysis.ResultsRCT data showed that 16.9% to 28.0%, 42.7% to 54.4%, and 16.9% to 38.1% of patients with T2DM had well‐controlled glycemia, residual hyperglycemia, and uncontrolled hyperglycemia, respectively. In CTRs, respective ranges were 21.8% to 33.6%, 31.5% to 35.6%, and 30.7% to 46.8%, and in EMR databases were 4.4% to 21.0%, 23.9% to 31.8%, and 53.6% to 63.8%. Significant predictor factors of residual hyperglycemia identified from RCT data included high baseline HbA1c (all countries/regions except Brazil), high baseline FPG (United Kingdom/Japan), longer duration of diabetes (Brazil), and female sex (Europe/Latin America).ConclusionsIrrespective of intrinsic differences between data sources, 24% to 54% of patients with T2DM globally had residual hyperglycemia with HbA1c not at target, despite achieving FPG control, indicating a significant unmet need for postprandial glycemic control.

Semaglutide improves postprandial glucose and lipid metabolism, and delays first‐hour gastric emptying in subjects with obesity

“…T2D is characterized by chronic hyperglycaemia caused by insulin resistance or reduced insulin secretion . Despite the availability of several anti‐diabetic drugs, there remains an unmet need for better therapies because a significant proportion of individuals with T2D do not achieve recommended treatment targets for glycaemic control . Inadequately controlled T2D can result in various complications, including an increased risk of cardiovascular disease .…”

Commencing insulin glargine 100 U/mL therapy in individuals with type 2 diabetes: Determinants of achievement of HbA1c goal less than 7.0%

“…Currently, 24%‐54% of individuals with T2DM worldwide prescribed supplementary basal insulin do not achieve their therapeutic targets . Clinical inertia, defined as failure to adequately intensify treatment regimens sufficiently early, is an important contributing factor .…”

“…Therefore, a better understanding of the relationship between baseline characteristics and glycaemic outcomes may help to prevent unnecessary delay in optimizing the use of basal insulin therapy. Previous studies have investigated the relevance of baseline characteristics to determine effective outcomes in individuals with T2DM who are initiating insulin therapy . Those characteristics that have been shown to be associated with an inadequate glycaemic response, that is, not achieving HbA1c less than 7.0% (<53 mmol/mol), include the number of oral anti‐hyperglycaemic drugs (OADs) prescribed at baseline, in addition to HbA1c, fasting plasma glucose (FPG) levels, body mass index (BMI), diabetes duration and sex …”

What next after basal insulin? Treatment intensification with lixisenatide in Asian patients with type 2 diabetes mellitus

“…Evidence suggests that a substantial proportion of patients with T2DM do not achieve target HbA1c levels, despite adequate control of FPG, and unsatisfactory PPG control is the likely culprit in many of these patients . Postprandial plasma glucose is an independent predictor of cardiovascular (CV) risk and a better predictor of CV disease than FPG or HbA1c .…”

“…Even after basal insulin has been titrated appropriately, glycemic targets are not achieved in 40–50% of patients or targets are not maintained . In addition, some patients receiving optimally titrated basal insulin with well‐controlled FPG may fail to maintain target HbA1c levels owing to the contribution of PPG to overall glycemia . These patients in particular may benefit from additional measures to address PPG excursions, which are not controlled by basal insulin …”