Observational Registry of Basal Insulin Treatment (ORBIT) in patients with type 2 diabetes uncontrolled with oral antihyperglycaemic drugs: Real‐life use of basal insulin in China

Abstract

Aims: To examine treatment patterns following basal insulin (BI) introduction in type 2 diabetes mellitus (T2DM) patients under real-world conditions across China. Materials and methods:Overall, 18 995 patients inadequately controlled (HbA1c ≥ 53 mmol/ mol [7%]) with oral antihyperglycaemic drugs (OADs) and willing to receive BI treatment were registered at 209 hospitals and followed at baseline (visit 1), 3 months (visit 2) and 6 months (visit 3). Type of BI was initiated at physicians' discretion.Results: Retention with BI therapy at 6 months was 75.6%. Use of long-acting BI predominated, with insulin glargine accounting for 71%, detemir 13% and Neutral Protamine Hagedorn (NPH) insulin 16%. Over 70% of long-acting users maintained the same initial BI at visit 3, while 40% of NPH users switched treatment and 24.4% of participants initiated BI with prandial insulin. The initial mean (AE SD) dose of BI and total insulin was 0.18 AE 0.07 and 0.25 AE 0.19 IU/ kg, respectively, with a mean increase of daily dose by 0.03 and 0.02 IU/kg after 6 months, respectively. Only 56.6% of insulin users reported dose titration at visit 3. Mean HbA1c was 81 mmol/mol (9.6%) at baseline and 57 mmol/mol (7.4%) at 6 months. The frequency of hypoglycaemia was 1.61 and 2.07 episodes/patient-year at baseline and 6 months, respectively. Conclusions:In real-world clinical settings, add-on BI therapy in T2DM patients is associated with significant improvement in glycaemic control without overtly compromising safety related to hypoglycaemia and weight gain. Evolution of insulin treatment regimens varied among patients, but dose titration was suboptimal. More active BI dose titration might further improve glycaemic outcome in patients receiving BI therapy.

Comparative effectiveness and safety of different basal insulins in a real‐world setting

“…This study compared effectiveness and safety among 3 different BIs in a real‐world clinical setting, and further enriched findings in our previous analyses where we reported that add‐on BI treatment was effective and relatively safe in general . The present study demonstrated that, after adjusting for potential bias from baseline variables and process factors, reduction of HbA1c differed among the 3 groups receiving different BI therapies, with a larger reduction of HbA1c levels in long‐acting insulin analog groups than in the NPH group.…”

“…The Observational Registry of Basal Insulin Treatment (ORBIT) is a large‐scale, prospective, observational multicentre study that is designed to evaluate the efficacy of BI therapy among T2DM patients inadequately controlled with OADs in a real‐world clinical setting in China . A previous paper reported real‐world BI treatment patterns, focusing on initiation and following the evolution of treatment regimens and insulin dosing, as well as the effect on overall blood glucose control and safety issues . Based on the ORBIT study, this analysis aims to compare the safety and effectiveness of the 3 most commonly used BIs (glargine, detemir and NPH) in China.…”

Fixed versus flexible combination of GLP‐1 receptor agonists with basal insulin in type 2 diabetes: A retrospective multicentre comparative effectiveness study

“…In fact, titration of the BI dose was suboptimal in both groups, because FPG remained far from internationally recognized targets despite relatively lower insulin requirements (~0.2 units/kg). Nonetheless, an increase in BI dose from 20 to 26 units at 6 months in the fixed group was beyond that observed in the ORBIT study for patients using basal oral therapy . Further improvements in HbA1c could be expected in both groups if insulin doses were appropriately titrated.…”

Effectiveness and safety of empagliflozin‐based quadruple therapy compared with insulin glargine‐based therapy in patients with inadequately controlled type 2 diabetes: An observational study in clinical practice

“…Most Asian patients with T2D are relatively lean and have a higher risk of hypoglycaemia associated with insulin use than Caucasian counterparts . Similarly, another study conducted in China found that there was inadequate titration of basal insulin to control blood glucose, and that the proper titration of basal insulin requires active recommendation by the health care provider and the willingness of the patient to comply with their medical guidance . Therefore, resistance on the part of patients to adhere to the appropriate insulin regimen could be confounded by the composition of the study group as the result of geographic and physiological factors.…”