Patient-led Titration with Lantus(R) is Effective at Lowering Blood Glucose

AsiaNet 53504

PARIS, France, June 24 / PRN=KYODO JBN/ --

- 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[1] and patient self-management

is key to optimizing treatment outcomes.[2] However, despite this, basal

insulin is not as widely adopted in Asia. Initiation from diagnosis is often

delayed[3] 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."

About Diabetes

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.[4]

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.

About Sanofi

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).

References

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, 2013)

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Source: Sanofi Diabetes