PARIS, France, June 24, 2013 /PRNewswire/ --
- Self-empowerment for titration showed to be effective in ATLAS while education helps managing the slightly increased hypoglycemia risk in patient-led study arm -
Sanofi (EURONEXT : SAN and NYSE : SNY) announced today data from the Asian Treat to Target Lantus® Study (ATLAS) showing that dosing of Lantus® (insulin glargine) can be successfully self-adjusted by patients with type 2 diabetes to achieve glycemic control or administered in a physician-led program.
Insulin therapy is widely established as an effective and well tolerated treatment for the management of type 2 diabetes and patient self-management is key to optimizing treatment outcomes. However, despite this, basal insulin is not as widely adopted in Asia. Initiation from diagnosis is often delayed and target glucose lowering is rarely achieved due to insufficient dose titration.
"Asian Treat to Target Lantus Study (ATLAS): A 24-Week Randomized, Multinational Study" [Poster number: 940-P]
ATLAS, a randomized, multinational, 24-week study, compared the effectiveness of a patient- versus physician-led initiation (usual standard of care) of insulin glargine-based basal management. A total of 552 patients from Japan, China, Pakistan, India, the Philippines, and Russia with type 2 diabetes were randomly allocated to two titration arms: 275 patient-led, 277 physician-led. Both treatment groups adjusted their insulin dose using the same algorithm to achieve target fasting blood glucose levels of 110mg/dl.
Results show that patients with uncontrolled glucose levels can effectively self-adjust their insulin glargine to lower their blood glucose to near target levels, without increased occurrence of severe hypoglycemia versus physician-led titration (0.7% vs. 0.7%), with higher nocturnal hypoglycemia (16.4% vs. 6.5%, p=0.002), higher symptomatic hypoglycemia (36.0% vs. 25.6%, p=0.02), and few unrelated serious adverse events (3.3% vs. 1.8%). Levels of HbA1c decreased in both treatment arms by an average of 1.2% at week 12 and 1.3% at week 24. Notably, patients self-titrated up to a significantly higher daily dose of insulin compared to the physician-led group, with a difference of 6.7 units/day (p<0.001) by week 24. In comparing the relative reduction of average glucose concentration, patient-led titration was found to be superior to physician-led titration, with a -0.15 change in mean HbA1c from baseline at 24 weeks (p=0.04).
"Evaluating the Patient Experience in the Asian Treat to Target Lantus Study (ATLAS): A 24-Week, Randomized, Multinational Study" [Poster number: 1242-P]
Patients self-titrating basal insulin showed improvements in health-related quality of life (QoL) scores comparable to levels scored by patients under physician-led titration. Diabetes Treatment Satisfaction Questionnaire status and change scores were similar between the two titration arms, with both groups showing significant improvements at 24 weeks (p<0.001). Cross-country differences in health-related QoL, as identified by the EuroQol EQ-5D patient survey, were eliminated by the end of the study.
"Subjects with type 2 diabetes from Asia face specific challenges in managing their condition and patient self-administration of insulin is sometimes perceived as difficult, resulting in a very limited dose adjustment to reflect the individual's insulin needs to achieve glycemic target," commented Satish Garg, MD, Professor of Medicine and Pediatrics, University of Colorado, Denver, and Editor-in-Chief of Diabetes Technology & Therapeutics. "ATLAS shows that a broad range of patients, including Asians, can successfully lower blood glucose by adjusting their insulin dose themselves. These findings could be translated into future guidance in Asian countries that supports a self-management program when patients start basal insulin therapy."
Results from ATLAS demonstrated that dose increase of Lantus® in patients with type 2 diabetes new to insulin therapy in Asia, Russia and Japan, whether self-titrated by patients themselves or supervised in a physician-led program, is effective in achieving near target glycemic control on top of two oral anti-diabetic medications. Results also showed that there was no difference in the incidence of severe hypoglycemia. Also, patients initiating Lantus® by self-titration may do so without compromising health-related QoL or treatment.
Pierre Chancel, Senior Vice President, Global Diabetes, Sanofi said: "As a leader in integrated diabetes care, Sanofi focuses on providing simple and convenient solutions to improve outcomes for people living with diabetes in both developing and western countries. The results of ATLAS suggest that Lantus® offers adaptable patient- or physician-led once-daily administration suitable for a wide variety of patient populations."
Diabetes is a chronic disease that occurs as type 1 diabetes, which is an autoimmune disease characterized by the lack of insulin (the hormone that regulates blood glucose concentrations) production by the pancreas, and type 2, a metabolic disorder in which there are two main biological defects: a deficient production of insulin and reduced ability of the body to respond to the insulin being produced. Type 1 and type 2 diabetes are characterized by an increase in blood glucose concentrations (hyperglycemia). Over time, uncontrolled hyperglycemia leads to the macrovascular and microvascular complications of diabetes. Macrovascular complications, which affect the large blood vessels, include heart attack, stroke and peripheral vascular disease. Microvascular complications affect the small blood vessels of the eyes (retinopathy), kidney (nephropathy) and nerves (neuropathy). The global incidence of diabetes is growing at an alarming rate, with more than 371 million people worldwide living with the condition today.
About Sanofi Diabetes
Sanofi strives to help people manage the complex challenge of diabetes by delivering innovative, integrated and personalized solutions. Driven by valuable insights that come from listening to and engaging with people living with diabetes, the Company is forming partnerships to offer diagnostics, therapies, services and devices, including blood glucose monitoring systems. Sanofi markets both injectable and oral medications for people with type 1 or type 2 diabetes.
Sanofi, an integrated global healthcare leader, discovers, develops and distributes therapeutic solutions focused on patients' needs. Sanofi has core strengths in the field of healthcare with seven growth platforms: diabetes solutions, human vaccines, innovative drugs, consumer healthcare, emerging markets, animal health and the new Genzyme. Sanofi is listed in Paris (EURONEXT: SAN) and in New York (NYSE: SNY).
- Inzucchi SE et al. Management of hyperglycaemia in type 2 diabetes: a patient-centered approach. Position statement of the American Diabetes Association (ADA) and the European Association for the Study of Diabetes (EASD). Diabetologia 2012; 55: 1577-1596.
- Davies M et al. Improvement of glycemic control in subjects with poorly controlled type 2 diabetes. Diabetes Care 2005; 28: 1282-1288.
- Khunti K et al. Self-titration of insulin in the management of people with type 2 diabetes: a practical solution to improve management in primary care. Diabetes, Obesity and Metabolism 2013; doi:10.1111/dom.12053. [Epub ahead of print].
- International Diabetes Federation. IDF Diabetes Atlas, 5th edition: 2012 update. Brussels, Belgium, 2011. http://www.idf.org/diabetesatlas (Accessed: June, 2013)
This press release contains forward-looking statements as defined in the Private Securities Litigation Reform Act of 1995, as amended. Forward-looking statements are statements that are not historical facts. These statements include projections and estimates and their underlying assumptions, statements regarding plans, objectives, intentions and expectations with respect to future financial results, events, operations, services, product development and potential, and statements regarding future performance. Forward-looking statements are generally identified by the words "expects", "anticipates", "believes", "intends", "estimates", "plans" and similar expressions. Although Sanofi's management believes that the expectations reflected in such forward-looking statements are reasonable, investors are cautioned that forward-looking information and statements are subject to various risks and uncertainties, many of which are difficult to predict and generally beyond the control of Sanofi, that could cause actual results and developments to differ materially from those expressed in, or implied or projected by, the forward-looking information and statements. These risks and uncertainties include among other things, the uncertainties inherent in research and development, future clinical data and analysis, including post marketing, decisions by regulatory authorities, such as the FDA or the EMA, regarding whether and when to approve any drug, device or biological application that may be filed for any such product candidates as well as their decisions regarding labelling and other matters that could affect the availability or commercial potential of such product candidates, the absence of guarantee that the product candidates if approved will be commercially successful, the future approval and commercial success of therapeutic alternatives, the Group's ability to benefit from external growth opportunities, trends in exchange rates and prevailing interest rates, the impact of cost containment policies and subsequent changes thereto, the average number of shares outstanding as well as those discussed or identified in the public filings with the SEC and the AMF made by Sanofi, including those listed under "Risk Factors" and "Cautionary Statement Regarding Forward-Looking Statements" in Sanofi's annual report on Form 20-F for the year ended December 31, 2012. Other than as required by applicable law, Sanofi does not undertake any obligation to update or revise any forward-looking information or statements.
SOURCE Sanofi Diabetes