Sanofi has launched Toujeo®, a new generation innovative basal insulin designed to improve diabetic patient treatment experience. This long acting insulin is used to control blood glucose level in adults who have Type 1 (T1D) or Type 2 diabetes (T2D), and has been approved by the Health Sciences Authority (HSA) in Singapore as of February 2017.
Diabetes is a condition where the sugar level in blood is above normal. Patients with T1D are unable to make insulin naturally and those with T2D cannot make proper use of the insulin produced by the body. If left uncontrolled, diabetes can lead to serious complications. T1D accounts for 10% of patients, while T2D occurs more often, representing 90% of diabetes cases. Today, diabetes is the 10th leading cause of death in Singapore. Around 440,000 Singapore residents aged 18 and above have diabetes in 2014. There were 541,600 cases of diabetes in Singapore in 2015  and it is anticipated that 670,000 people will have diabetes in 2030. In 2016, the Singapore Ministry of Health declared a ‘war against diabetes’, promoting healthy lifestyle, and early screening and intervention.
At the launch event of Toujeo®, Dr Ben Jen-Min Ng, Endocrinologist & Specialist in Internal Medicine at the Arden Endocrinology Specialist Clinic Pte Ltd, Singapore, said that T2D is associated with some serious complications such as blindness and eye diseases, kidney failure, stroke, heart diseases, nerve disorders and amputation. These diabetic complications, however, can actually be prevented if patients start insulin treatment earlier. Today, numerous new medications and useful treatments are available for diabetes. Patients are looking for a diabetic treatment that is easy to use and understand, so that they do not merely ‘suffer’ from diabetes, but learn to ‘live’ with it, that it becomes a part of their life. However, insulin is by far the most powerful anti-diabetic agent at present to lower blood sugar, because it works faster than oral medications. Small dose adjustments can be made and the doses can be adjusted according to lifestyle.
Nevertheless, conventional insulins have some limitations. The usage of insulin is hampered by some factors such as poor delivery methods and devices whereby patients may face difficulty in the administration of drug and the device usage. The drug intake regime can be complicated, involving multiple injections and careful dose adjustments, and it is challenging to make the patients understand the instructions and to be aware of the side effects of the treatment. Additionally, unstable and unpredictable release of conventional insulins may occur, causing disorientation or lack of focus.
Based on the abovementioned challenges, novel therapies are needed to improve overall outcome and diabetes control – and the precision behind Toujeo® surpasses the limitations of current insulin therapies.
Toujeo® is a longer acting insulin with improved formulation of a broadly-used molecule, insulin glargine, providing consistent control of blood glucose level for 24 hours and beyond. Dr Vivek Verma, Head of Medical Affairs, Asia, at Sanofi, shared that the new formulation is also called U-300 because it offers 300 Units/mL, which is three times more concentrated than the current insulin glargine injection, U-100 (100 Units/mL). With higher concentration and reduced volume, more insulin can be delivered in a small amount of the fluid and potentially reduce pain among patients.
Another advantage of Toujeo® is that it only needs to be administered once daily, through the SoloSTAR® pen device, a disposable prefilled pen which contains 450 units of Toujeo®. Toujeo® SoloSTAR features a small thin needle, a push-button injection with a hold time of only 5 seconds, and a large dosing display window with clear visibility a dial-in dose. 
Compared to the previous generation of insulin glargine injection, Toujeo® has a longer effect as smaller micro-precipitate is used to contain the insulin molecules. The smaller surface area allows slower leak of the insulin molecules from the ‘ball’, giving rise to sustained release of insulin into the tissue. Toujeo® injection can be taken in the morning, afternoon or evening as they provide similar effect. Patients can administer Toujeo 3 hours before or after their usual time of daily administration providing a level of flexibility on the time of dosing schedule. Dr Vivek Verma also said that using Toujeo® could help to reduce the risk of hypoglycaemia and night-time hypoglycaemia among patients, with more predictable glucose control and greater predictability for titration. Its design eases the delivery of insulin, with less effort required to push the plunger – a shorter hold time of 5 seconds instead of 10 seconds for U-100.
Market authorization for Toujeo® in Singapore was granted based on the results from the EDITION clinical trial program, an extensive worldwide series of Phase 3 studies (4 global and 2 Japanese studies), involving over 3,500 adults with uncontrolled diabetes on their current therapies, demonstrating the efficacy and safety of Toujeo® in diverse patient populations. Results showed that Toujeo® demonstrated similar blood sugar control that lasted beyond 24 hours with less hypoglycemia compared to U-100 in all EDITION studies, conducted in both Type 1 and Type 2 diabetes patients [4,5,6].
Dr Alice Cheng is a Member of the division of Endocrinology and Metabolism at Trillium Health Partners (Credit Valley Hospital) in Mississauga and St. Michael's Hospital in Toronto and an Associate Professor in the Department of Medicine at the University of Toronto. She said at the product launch that Toujeo® provides a new way for diabetics to achieve constant glucose control, and the drug behaves similarly in patients, whether or not it is taken in the morning or evening. Therefore, Toujeo® is the improvement of standard insulin, U-100. Besides any newly diagnosed patient starting on basal-bolus insulin regimen, those who are experiencing low blood sugar (hypoglycemia) should consider to switch to Toujeo®. It was proven that the patients who switched from twice-a-day basal insulin to once daily dosing also benefited from Toujeo®.
Insulin treatment is essential to restore glucose control in patients with diabetes. However, doctors have taken into account patients’ main concerns about starting insulin – fear of weight gain and fear of hypoglycemia, afraid of pain from injection and pain from blood tests. At the end of the Toujeo® launch event, the experts emphasized that it is crucial to continuously create awareness among diabetic patients on the importance of early insulinization to prevent progression of the condition.
- International Diabetes Federation (Western Pacific). Available at: https://www.idf.org/membership/wp/singapore
- Starting on Toujeo®. Available at: https://www.toujeo.com/starting-on-toujeo
- Toujeo product information. Health Sciences Authority (HSA) Singapore. Registration number SIN15138P.
- Ritzel RA, Roussel R, Bolli GB et al. Patient-level meta-analysis of the EDITION 1, 2 and 3 studies: glycaemic control and hypoglycaemia with new insulin glargine 300 U/ml versus glargine 100 U/ml in people with type 2 diabetes. Diabetes Obes Metab. 2015 Sep;17(9):859-67
- Home PD, Bergenstal RM, Riddle MC et al. New Insulin Glargine 300 Units/mL Versus Glargine 100 Units/mL in People With Type 1 Diabetes: A Randomized, Phase Open-Label Clinical Trial (EDITION 4). Diabetes Care. 2015 Dec;38(12):2217-2
- Matsuhisa M., et al. (EDITION JP 1) Diabetes Obes Metab 2016;18(4):375-83. 9. Terauchi Y., et al. (EDITION JP 2). Diabetes Obes Metab 2016;18(4):366-74.
This article is written by APBN Catherine D. Ong and Carmen J.W. Loh, based on the press materials given by Sanofi.