Real-World Effectiveness and Safety of Insulin Glargine 300 U/mL in Insulin-Naïve People with Type 2 Diabetes: the ATOS Study

Abstract

Introduction: The clinical benefits of insulin glargine 300 U/mL (Gla-300) have been confirmed in randomised clinical trials (EDITION programme and BRIGHT) and real-world studies in the USA and Western Europe. ATOS evaluated the real-world effectiveness and safety of Gla-300 in wider geographic regions (Asia, the Middle East, North Africa, Latin America and Eastern Europe).

Methods: This prospective observational, international study enrolled adults (≥ 18 years) with type 2 diabetes mellitus (T2DM) uncontrolled [haemoglobin A1c (HbA1c) > 7% to ≤ 11%] on one or more oral anti-hyperglycaemic drugs (OADs) who had been advised by their treating physician to add Gla-300 to their existing treatment. The primary endpoint was achievement of a pre-defined individualised HbA1c target at month 6.

Results: Of the 4550 participants included, 4422 (51.8% female) were eligible for assessment. The mean ± standard deviation (SD) age was 57.2 ± 10.8 years, duration of diabetes was 10.2 ± 6.2 years and baseline HbA1c was 9.28 ± 1.0%. The proportion of participants reaching their individualised glycaemic target was 25.2% [95% confidence interval (CI) 23.8-26.6%] at month 6 and 44.5% (95% CI 42.9-46.1%) at month 12. At months 6 and 12, reductions were observed in HbA1c (-1.50% and -1.87%) and fasting plasma glucose (-3.42 and -3.94 mmol/L). Hypoglycaemia incidence was low, and body weight change was minimal. Adverse events were reported in 283 (6.4%) participants, with 57 (1.3%) experiencing serious adverse events.

Conclusion: In a real-world setting, initiation of Gla-300 in people with T2DM uncontrolled on OADs resulted in improved glycaemic control and low rates of hypoglycaemia with minimal weight change.

Trial registration: Clinicaltrials.gov number NCT03703869.

Keywords: Basal insulin; Glycaemic control; Hypoglycaemia; Insulin glargine 300 U/mL; Real-world; Type 2 diabetes.

Fig. 1

Percentage of participants reaching the pre-defined individualised HbA1c target, HbA1c < 7.5% and HbA1c < 8% at months 3, 6 and 12. *Achievement of individualised HbA1c target at 6 months is the primary endpoint of the study. Efficacy analyses were undertaken in the evaluable population, n = 3704 at month 3, n = 3931 at month 6 and n = 3748 at month 12. ^#The 3-month period was defined as first treatment administration to visit 2 (month 3); the 6-month period was defined as first treatment administration to visit 3 (month 6) or treatment discontinuation, whichever occurred first, and the 12-month treatment period was defined as first treatment administration to visit 4 (month 12) or treatment discontinuation, whichever occurred first. HbA1c haemoglobin A1c

Fig. 2

Mean HbA1c (A), FPG (B) and SMBG (C) levels at baseline and months 3, 6 and 12. Efficacy analyses were undertaken in the evaluable population. Data shown are mean ± SD. ^†HbA1c: n = 3704 at month 3, n = 3931 at month 6 and n = 3748 at month 12. ^‡FPG: n = 3565 at month 3, n = 3718 at month 6 and n = 3579 at month 12. ^§SMBG: n = 2071 at month 3, n = 2973 at month 6 and n = 2859 at month 12. ^¶The 3-month period was defined as first treatment administration to visit 2 (month 3); the 6-month period was defined as first treatment administration to visit 3 (month 6) or treatment discontinuation, whichever occurred first, and the 12-month treatment period was defined as first treatment administration to visit 4 (month 12) or treatment discontinuation, whichever occurred first. LS mean change was assessed using a mixed model for repeated measurements approach. CI confidence interval; FPG fasting plasma glucose, HbA1C haemoglobin A1c, LS least squares, SMBG self-monitored blood glucose