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Real-world data for Sanofi's Toujeo® (insulin glargine 300 units/mL (Gla-300)) shows statistically significant HbA1c improvements at 6 months in type 1 diabetes

Sanofi
Posted on: 19 Mar 18
Real-world data for Sanofi's Toujeo® (insulin glargine 300 units/mL (Gla-300)) shows statistically significant HbA1c improvements at 6 months in type 1 diabetes  Real-world data demonstrate Gla-300’s effectiveness as a long-acting basal analogue in treating patients in type 1 diabetes1  Gla-300 is a second generation basal insulin which shows similar HbA1c control to Lantus (insulin glargine 100units/mL) and similar or lower rates of hypoglycemia 1- GUILDFORD, UK – March 19, 2018 – Real-world retrospective data presented for the first time today at ENDO 2018, the Endocrine Society’s 100th Annual Meeting & Expo, in Chicago, show Sanofi’s Toujeo® (Gla-300), a once-daily long-acting basal analogue, is associated with statistically significant improvements in HbA1c in patients with type 1 diabetes.1 “These new data are a great addition to the existing body of evidence supporting the use of Gla-300 in diabetes,” says Terence Pang, Dudley Group NHS Foundation Trust and lead study author. “Gla-300 is well-established as a cornerstone treatment for type 2 diabetes and its use is supported by extensive clinical data. However, this evidence is not so abundant for the treatment of type 1 diabetes. These findings provide strong real-world evidence that can provide evaluations of the effectiveness of a medicine in daily use, and augment clinical data to further help HCPs make clinical decisions.” The UK study also showed that following initiation of Gla-300 there was no change in the number of patients reporting either diabetic ketoacidosis (DKA) or severe hypoglycaemia.1 The total number of hypoglycemic and DKA episodes reported by patients during the six months post-initiation of Gla-300 were 31/299 (10%) and 7/299 (2%), respectively. Prior to Gla-300 initiation, 17 (6%) patients reported mild/moderate and 6 (2%) experienced severe hypoglycemic episodes; post-initiation of Gla-300, 27 (9%) reported mild/moderate and 4 (1%) severe hypoglycemic episodes.1 Type 1 diabetes is a complex disease that requires 24/7 self-management and patients are at risk of life-threatening complications such as retinopathy, nephropathy, neuropathy and cardiovascular disease as well as more short-term complications including DKA, hypoglycaemia, seizures or loss of consciousness, diabetic comas and infections. Uncontrolled blood glucose levels in people with type 1 diabetes can result in complications, frequent hospitalisation and even early death.8 More details on the study The data were gathered from 299 UK adults (aged ¬>18 and <75 years) as part of SPARTA, an observational, multicentre, retrospective, descriptive study. The study design was developed by Sanofi in collaboration with National Health Service (NHS) healthcare professionals (HCPs) in order to standardise real-world data collection from patients with type 1 diabetes, who have been prescribed Gla-300. Anonymised patient-level data were collected from eight NHS sites across the UK (located in South Yorkshire, West Midlands, Essex, Surrey, Northern Ireland, Wales and Scotland). The findings were consistent across the eight separate clinical settings and therefore represent UK-wide experience. The primary objective of the study was to describe the change in HbA1c levels from baseline to six months following initiation of Gla-300 in patients with type 1 diabetes. The mean difference in HbA1c from baseline to month six was –4.4 mmol/mol (95% confidence interval [CI]: −6.3, −2.5; p<0.001).1 This change was statistically significant.1 The study also looked at changes in basal insulin dose. The daily Gla-300 dose at 6 months was not significantly different from the prior basal insulin (BI) therapy dose; the total daily BI dose following Gla-300 initiation increased to month six (0.7U [95% CI: 0.13, 1.26; p<0.05]) but did not exceed the prior BI dose. The study also looked at the number of hypoglycaemic episodes and diabetic ketoacidosis (DKA) events reported by patients. The total number of hypoglycemic and DKA episodes reported by patients during the six months post-initiation of Gla-300 were 31/299 (10%) and 7/299 (2%), respectively. Prior to Gla-300 initiation, 17 (6%) patients reported mild/moderate and 6 (2%) experienced severe hypoglycemic episodes; post-initiation of Gla-300, 27 (9%) reported mild/moderate and 4 (1%) severe hypoglycemic episodes.1 - ends – Notes to Editors About Toujeo® (Insulin glargine 300 units/mL) The European Medicines Agency (EMA) licensed insulin glargine 300 units/mL (Gla-300) in February 2015. It has also been licensed by the US Food and Drug Administration (FDA). The European licence was based on an assessment of the results from the EDITION clinical trial programme, which evaluated the efficacy and safety compared to Lantus (insulin glargine 100 units/mL) in over 3,500 people with diabetes.2-7, , Gla-300 is a more concentrated formulation of the insulin glargine molecule, the active ingredient of the basal insulin therapy Lantus (insulin glargine 100 units/ml). About Type 1 Diabetes Type 1 diabetes is a chronic auto-immune condition where the body produces little or no insulin. The risk of developing type 1 diabetes in the general population is 1 in 250. The UK has one of the highest rates of type 1 diabetes in the world, for reasons that are currently unknown. If rates continue to rise, the global incidence of diabetes could double in the next decade. Editor's Details

Tamara Ghanem
Red
tamara.ghanem@redconsultancy.com

Last updated on: 19/03/2018

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