Glycaemic control and hypoglycaemia burden in patients with type 2 diabetes initiating basal insulin in Europe and the USA

Abstract

Aims: To evaluate short- and long-term glycaemic control and hypoglycaemia incidence in insulin-naïve patients ≥30 years of age with type 2 diabetes (T2DM) initiating basal insulin (BI) with or without oral anti-hyperglycaemic drugs (OADs).

Methods: This was an observational, retrospective longitudinal analysis of electronic medical records from 5 European countries and the USA. A multivariable logistic regression model assessed baseline and short-term (0-3 months post BI initiation) factors associated with long-term (3-24 months) glycaemic control and hypoglycaemia.

Results: Overall, 40 627 patients were included; 20.9% and 27.8% achieved the general HbA1c target of ≤7% at 3 and 24 months post BI initiation, respectively. Failure to achieve HbA1c ≤7% at 3 months was associated with increased risk of failing to achieve target at 24 months (odds ratio [OR], 3.70 [95% CI, 3.41-4.00]). Over 24 months, 8.9% of patients experienced a recorded hypoglycaemic event. Hypoglycaemia during the initial 3-month period was associated with longer-term risk of these events over the ensuing 3 to 24 months (OR, 5.71 [95% CI, 4.67-6.99]).

Conclusions: Initiating BI with or without OADs is associated with short- and long-term suboptimal glycaemic control; the majority of patients fail to achieve HbA1c target ≤7% in the first 3 months, or after 2 years of BI treatment. Treatment response and hypoglycaemia incidence by 3 months post BI initiation are associated with longer-term glycaemic control and hypoglycaemic risk, respectively. These results support the need for early anti-hyperglycaemic interventions that more effectively control blood glucose levels without increasing the risk of hypoglycaemia.

Keywords: basal insulin; glycaemic control; hypoglycaemia; type 2 diabetes.

Figure 1

A, Mean HbA1c at index date and during 24 months post index. B, Percentage of patients at HbA1c target (≤7.0%) at 24 months post index

Figure 2

Odds ratios A, for risk of not achieving target HbA1c ≤7.0% after 24 months if target is not achieved in the first 3 months, and B, for risk of hypoglycaemia after 24 months if hypoglycaemia is experienced in the first 3 months. CI, confidence interval; OR, odds ratio. Results adjusted for A, pre‐index HbA1c levels and B, pre‐index hypoglycaemia experience. For the 3‐month time point, the closest available HbA1c value was to be used and must have been measured between 2 and 4 months after BI initiation. For other time points after the index date, the HbA1c value nearest to that time point was to be used and the measurement should not have overlapped with that used at the 3‐month time point. Overall OR was derived from a meta‐analysis of results from all 6 countries, using an inverse‐variance weighted method

Figure 3

Percentage of patients experiencing hypoglycaemia during the 1‐year pre‐index period and during the 1‐year and 2‐year post‐index periods

Figure 4

Concomitant medication use (proportion of patients who filed for a prescription at least once) during the 1‐year pre‐index period/at index date and at 1‐year post index. A, Concomitant non‐insulin antihyperglycaemic medications; B, basal insulin, premix and rapid‐acting insulin (post index only). DPP‐4, dipeptidyl peptidas‐4; GLP1‐RA, glucagon‐like peptide‐1 receptor agonists