Predictors of treatment response in type‐2 diabetes patients initiating basal‐supported oral therapy with insulin glargine 100 U/mL: A sub‐analysis of the Titration and OPtimisation (TOP) registry

Abstract

The aim of this study was to identify predictors of long-term response to the initiation of basal-supported oral therapy (BOT) with insulin glargine (IGlar-100). Patients from the observational TOP registry were grouped based on those who had achieved (responders) and those who had not achieved (non-responders) their HBA1c target and/or FBG ≤110 mg/dL 12 months after IGlar-100 initiation. Independent predictors of treatment response were identified by regression analysis. Data for 2444 patients were analysed (responders, n = 1610; non-responders, n = 834). Although the IGlar-100 dose increase over 12 months was larger for non-responders (+12.83 vs +9.46 U/d; P < 0.0001), the corresponding decrease in HbA1c was smaller (−0.88% vs −1.57%). Independent predictors of response included lower BMI (OR, 0.97; 95% CI, 0.95-1.00), lower FBG (OR, 0.98; 95% CI, 0.97-0.98) and HbA1c values at baseline (OR, 0.24; 95% CI, 0.18-0.31), a less ambitious HbA1c target (OR, 5.07; 95% CI, 3.37-7.63) and bedtime administration of IGlar-100 (OR, 1.55; 95% CI, 1.12-2.14). In conclusion, HbA1c was the clinically most significant baseline characteristic predictive of response to BOT. This may suggest an advantage of IGlar-100 initiation prior to excessive hyperglycaemia escalation.basal, basal-supported oral therapy, hypoglycaemia, insulin glargine, response duration, 6 lower body weight 5 and older age 7 at the time of insulin initiation. The ALOHA2 study of Japanese patients initiating BOT with insulin glargine 100 U/mL (IGlar-100) found achievement of HbA1c of 7% (53 mmol/mol) or less at 6 months to be associated with a shorter diabetes duration and lower HbA1c prior to insulin introduction. 8The primary aim of the present TOP sub-analysis was to compare the characteristics and therapeutic management of responders to those of non-responders and to identify predictors of long-term response to BOT with IGlar-100 in a German population. | METHODS | Study designThe methodology of the prospective, observational TOP registry has been described previously. 9 The registry gathered data on patients with inadequately controlled T2DM who were initiating IGlar-100 BOT at German general practices between October 2013 and October 2015. Registry approval was provided by the relevant local ethics committees. Written informed consent to participate was given by all patients. | DocumentationPatient demographics, current HbA1c and FBG levels, and details of antidiabetic medication (OADs or insulin) were recorded at baseline, defined as the day of IGlar-100 initiation. Physicians assigned each patient an individual HbA1c target at this time, independently of study participation.Any IGlar-100 titrations or changes to basal insulin, that is, switching to a different type, that occurred between baseline and the end of the 12-month follow-up period were recorded, with HbA1c and FBG measurements documented at regular intervals. Any episodes of hypoglycaemia were also detailed and categorised as: symptomatic; symptomatic and confirmed (blood glucose ≤70 mg/dL); ...

Practical application of short-term intensive insulin therapy based on the concept of “treat to target” to reduce hypoglycaemia in routine clinical site

“…Many treatment algorithms and clinical trials of T2DM with beta cell death have been proposed so far [31][32][33][34] . Basal-Bolus, Basal plus, Basal supporting oral therapy (BOT), premixed insulins and premixed insulin and GLP-1R agonist were reported to improve safety and efficacy of the patient treated mainly in out-patient clinic [35][36][37][38][39][40][41][42] .…”

How to Classify Type 2 Diabetes Mellitus and Approach its Treatment in View of Associated Diabetes and Complications-A Short Communication

“…Pfohl et al [25] aimed to find out predictors of long-term response to the initiation of basal-supported oral therapy (BOT) with insulin glargine (IGlar-100). Patients from the observational titration and optimisation (TOP) registry were grouped into those who had achieved (responders) and who had not achieved (non-responders) their HbA1c target and FBG ≤110 mg/dL 12 months after IGlar-100 initiation.…”