Efficacy and Safety of Switching Patients Inadequately Controlled on Basal Insulin to Insulin Glargine 300U/mL: The TRANSITION2 Study.

Abstract

IntroductionThis study aimed to determine, in close to real-life conditions, the efficacy and safety of switching from any basal insulin to insulin glargine 300 U/mL (Gla-300) in patients with uncontrolled type 2 diabetes (T2D).MethodsThis was an interventional, multicenter, single-arm, prospective study with a 24-week treatment phase. Adult patients with T2D treated with basal insulin with or without other antidiabetics, HbA1c > 7.5%, and fasting self-monitored blood glucose (F-SMBG) > 130 mg/dL (mean of three measures) at baseline were included. Insulin dose was titrated to reach F-SMBG 90–130 mg/dL. Efficacy and safety were assessed at 12 weeks (W12) and 24 weeks (W24). The main outcome parameter was HbA1c change between baseline and W24. Safety parameters included self-reported hypoglycemia (any type). Patients’ satisfaction with the treatment was assessed by the Diabetes Treatment Satisfaction Questionnaire (DTSQ).ResultsA total of 140 patients were included and 137 were treated. Mean HbA1c decreased from 8.64% at baseline to 8.14% at W12 (mean difference [95% CI] − 0.51% [− 0.64; − 0.38]) and 8.01% at W24 (− 0.64% [− 0.81; − 0.46]). Target F-SMBG was reached in 35.0% of the patients at W12 and 38.4% at W24. The percentages of patients reaching HbA1c levels < 7.0%, < 7.5%, and < 8.0% at W24 were 11.4%, 29.5%, and 50.8%, respectively, while only 31.6% had an HbA1c value < 8.0% at baseline. HbA1c reduction was greater in patients with higher baseline levels. During the treatment phase, 46.0% of the participants had at least one hypoglycemia event; 31.4% documented symptomatic hypoglycemia, 2.2% severe hypoglycemia, and 12.2% nocturnal hypoglycemia. Treatment satisfaction increased by 20% between baseline and W24.ConclusionThese data, derived from close to real-life practice in France, confirm the reassuring results of randomized trials on the efficacy and safety of Gla-300.Trial RegistrationEudraCT number 2015-002416-33.Electronic Supplementary MaterialThe online version of this article (10.1007/s13300-019-00734-8) contains supplementary material, which is available to authorized users.