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(R) Study (ATLAS) showing that dosing of Lantus(R) (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(R) 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(R) 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(R) 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).
1) 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.
2) Davies M et al. Improvement of glycemic control in subjects with poorly
controlled type 2 diabetes. Diabetes Care 2005; 28: 1282-1288.
3) 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].
4) International Diabetes Federation. IDF Diabetes Atlas, 5th edition: 2012
update. Brussels, Belgium, 2011. http://www.idf.org/diabetesatlas (Accessed: June,
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Source: Sanofi Diabetes