Introduction The aim of this study is to demonstrate the real-life effectiveness and safety of insulin glargine 300 U/mL (Gla-300) in patients with type 2 diabetes (T2D) previously uncontrolled on NPH ± prandial insulin or premixed insulins in routine clinical practice in Bulgaria. Methods This was a 24-week prospective, observational study performed in 40 inpatient and outpatient sites across the country. Results A total of 286 patients were included in the study. The mean age (± SD) was 61.2 ± 10.0 years with duration of diabetes of 11.64 ± 7.5 years and body mass index (BMI) of 32.1 ± 5.7 kg/m 2 . HbA1c before Gla-300 initiation was 9.8 ± 1.0%, and fasting plasma glucose (FPG) was 13.1 ± 3.4 mmol/L. HbA1c and FPG change from baseline to week 24 was − 1.86% ( p < 0.001) and − 4.8 mmol/L ( p < 0.001), respectively. The proportion of patients reaching their individualized HbA1c at week 24 was 39.1% (95% CI 33.3–45.1%), while the proportion of patients reaching their individualized HbA1c target without confirmed and/or severe hypoglycaemia was 34.8% (95% CI 29.2–40.7%). At study end, 19.0% (95% CI 14.6–24.1%) achieved HbA1c < 7%. Body weight decreased from 88.3 to 87.0 kg from baseline to week 24 with mean change of − 1.3 kg ( p < 0.001). The incidence and event rates of anytime confirmed (≤ 3.9 mmol/L) and/or severe hypoglycaemia were low: 7.7% and 0.42 events per patient-year, respectively. The overall Insulin Treatment Satisfaction Questionnaire (ITSQ) score increased from 53.2 to 78.2 from baseline to week 24 and the difference of 25.1 ± 21.5 points was significant ( p < 0.001). Conclusions In real-life settings, Gla-300 significantly improved glycaemic control and insulin treatment satisfaction in people with T2D who were inadequately controlled with NPH ± prandial insulin or premixed insulin analogues. Improvement of glycaemic control was associated with a very low risk of hypoglycaemia and with significant weight loss irrespective of the previous insulin regimen. Supplementary Information The online version contains supplementary material available at 10.1007/s13300-021-01022-0.
Introduction This study aimed to demonstrate the beneficial effect of lixisenatide as add-on therapy to oral antidiabetics (OADs) in type 2 diabetes mellitus (T2DM) patients in routine clinical practice in Bulgaria. Methods This was a prospective, observational, multicentre study evaluating the real-life effectiveness and safety of 24-week treatment with lixisenatide in previously uncontrolled T2DM patients on combination therapy with metformin and sulfonylurea on highest tolerable doses. Results A total of 262 patients were included in the study. The mean (± SD) age in the cohort was 56.2 ± 9.1 years. The mean duration of diabetes was 7.3 ± 6.0 years. The mean body mass index (BMI) was 39.7 ± 4.7 kg/m 2 . The mean glycated haemoglobin (HbA1c) at baseline was 8.8 ± 1.1%. The mean fasting plasma glucose (FPG) and postprandial plasma glucose (PPG) at baseline were 10.5 ± 3.1 mmol/L and 12.1 ± 3.4 mmol/L respectively. The proportion of patients achieving HbA1c < 7% at study end was 39.0% (95% CI 32.9–45.3). The proportion of patients reaching their individual HbA1c target was 49.0% (95% CI 42.6–55.4). The mean change in HbA1c from baseline was − 1.3 ± 1.2%. The mean change in FPG was − 2.4 ± 3.0 mmol/L and the mean change in PPG was − 3.2 ± 3.6 mmol/L. The mean body weight change from baseline was − 7.2 ± 5.5 kg. The mean BMI change was − 2.6 ± 1.9 kg/m 2 . The hypoglycaemia incidence was low: 6.1% for all hypoglycaemic events, 3.8% for symptomatic events and 0.4% for severe events. Conclusions Lixisenatide as add-on therapy to OADs in a real-life setting led to significant improvements in glycaemic control with low incidence of hypoglycaemia and beneficial weight loss. Lixisenatide was well tolerated with few patients having adverse events or discontinuing therapy. These findings are consistent with lixisenatide’s safety and efficacy profile established in randomized controlled trials (RCTs). Funding Sanofi Bulgaria. Electronic supplementary material The online version of this article (10.1007/s13300-019-0603-9) contains supplementary material, which is available to authorized users.
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