The Diabetes Unmet Need with Basal Insulin Evaluation (DUNE) study in type 2 diabetes: Achieving HbA1c targets with basal insulin in a real‐world setting

Abstract

Aims To describe in a real‐world setting the achievement of physician‐selected individualized HbA1c targets in individuals with type 2 diabetes, newly or recently initiated with basal insulin, and the association of hypoglycaemia with target achievement. Materials and methods A 12‐week, prospective, single‐arm, observational study of adults with type 2 diabetes, either newly initiated with any basal insulin or start on basal insulin within the preceding 12 months. At enrollment, eligible participants from 28 countries were treated with or without oral antihyperglycaemic drugs and/or GLP‐1 receptor agonists. Results Individualized targets for almost all of the 3139 evaluable participants (99.7%) had been set by their physicians, with 57% of participants having HbA1c targets between 7.0% and <7.5% (53 and <58 mmol/mol). By week 12, 28% and 27% of newly and previously initiated participants, respectively, achieved individualized HbA1c targets with modest average increases in daily insulin dose of 9 and 5 U (0.10 and 0.06 U/kg), respectively, from baseline (14 and 23 U [0.17 and 0.29 U/kg], respectively). Overall, 16% of participants experienced at least one episode of hypoglycaemia. Both the incidence and frequency of hypoglycaemia, but not the severity, were positively associated with a higher likelihood of achieving individualized HbA1c targets (P < 0.05). Conclusions In this prospective real‐world study, most participants using basal insulin did not achieve the individualized HbA1c targets set by their physicians. Participants who experienced symptomatic hypoglycaemia were more likely to achieve HbA1c targets than those who did not.

Efficacy and safety of insulin glargine/lixisenatide fixed‐ratio combination (iGlarLixi 1:1) in Japanese patients with type 2 diabetes mellitus inadequately controlled on oral antidiabetic drugs: A randomized, 26‐week, open‐label, multicentre study: The LixiLan JP‐O2 randomized clinical trial

“…The complementary nature of the combined agents, the simplicity of administration and titration, and the reduction in side effects contribute to the greater effectiveness of the fixed-ratio combination. 10,11 The average effective insulin dose in Japanese patients is generally lower than in the West, 12,13 with the pathophysiology of T2DM driven by relative insulin deficiency rather than insulin resistance. Japanese patients generally respond well to dipeptidyl peptidase-4 (DPP-4) inhibitors and GLP-1 RAs.…”

The importance of the initial period of basal insulin titration in people with diabetes

“…Despite the clinical benefits favouring second‐generation versus first‐generation BIs, including lower rates of hypoglycaemia, RWE suggests that patients are still not achieving glycaemic targets during the initial 12 weeks of treatment. For example, the DUNE study, a prospective, 12‐week real‐world observational study in insulin‐naïve and pretreated (within the preceding 12 months) individuals with T2D who initiated or switched BI therapy, showed that only 28% and 27% of these patients, respectively, achieved their individualized HbA1c targets . Failure to achieve these targets could have been because of insufficient dose titration, as only modest increases in dose were observed (mean 0.10 U/kg in insulin‐naïve patients and 0.06 U/kg in pretreated patients).…”

Results of Insulin Therapy in Type 2 Diabetes Mellitus Patients in the Czech Republic: Do They Reflect the Current Status in Other Countries?

“…The inclusion of this parameter could change the perspective of the HbA1c results substantially. In the DUNE study [6], individualized HbA1c targets were set up by patients’ physicians or the study experts according to international guidelines [7] into several groups: < 7% for 18% of patients, 7.0 to < 7.5% for 57%, 7.5 to < 8.0% for 17% and ≥ 8.0% for 6.8% of patients.…”