Initiation of Lantus leads to better glycemic control at similar weight gain

SanofiSanofi (EURONEXT: SAN and NYSE: SNY) announced data that demonstrates that initiating Lantus® (insulin glargine [rDNA origin] injection) in type 2 diabetes patients leads to better glycemic control and comparable and modest weight gain versus a comparator group consisting of other insulins, oral antidiabetics (OADs) and dietary changes. The lowest weight gain was seen in patients initiating treatment with baseline A1c levels below eight percent and in patients aged 65 and older. This data is being presented at the European Association for the Study of Diabetes (EASD) 47th Annual Meeting in Lisbon, Portugal.(1)

"Weight gain is a commonly perceived effect of using insulin in type 2 diabetes," said Jack Leahy of the University of Vermont and lead investigator of the data presented at the meeting. "This data demonstrates that initiation of Lantus® when A1C is less than eight percent may help to limit weight gain in this patient population."

A total of 2,900 patients were evaluated from nine pooled, randomized, controlled 24-week studies. In each study, Lantus® was tested against a comparator (63% other insulins, 32% OADs, 6% dietary). Weight gain was assessed by treatment, demographics, age and baseline A1C and FPG.

Weight gain with Lantus® was similar to weight gain for comparators (mean weight gain 2.2 kg vs. 2.1kg) but varied with patient baseline A1c and age. Patients with A1c below 8 percent had the lowest overall weight gain. Weight gain increased with increasing baseline A1c (Pearson correlation, glargine r=0.1951, p<0.0001; comparators r=0.2409, p<0.0001). In addition, patients aged 65 and older had the lowest weight gain; weight gain significantly decreasing as patient's age increased (Pearson correlation, glargine r=-0.1625, p<0.0001; comparators r=-0.1215, p<0.0001).

More patients achieved A1c less than or equal to seven percent with Lantus® versus comparators (58.3% vs. 52.7%; OR=1.27; p=0.0017), with the highest percentage of patients reaching target when glargine was initiated at the baseline A1c levels below eight percent (79.8% vs 70.4%, OR=1.76; p =0.0011). Older patients versus younger patients treated with Lantus® were more likely to achieve A1C less than or equal to seven percent (P=0.0055); there was no such trend for the comparator group.

Hypoglycemia (glucose confirmed <50 mg/dL) occurred significantly (p<0.0001) less often with Lantus® than the comparators, with the lowest estimate among Lantus® patients 65 years and older.

About Diabetes
Diabetes is a chronic, widespread condition characterized by high blood sugar in which the body does not produce or properly use insulin, the hormone needed to transport glucose (sugar) from the blood into the cells of the body for energy. It is estimated that approximately 285 million adults worldwide are living with the disease and this number is expected to rise to a staggering 438 million within 20 years. It is estimated that nearly 26 million Americans have diabetes, including an estimated 7 million who remain undiagnosed. At the same time, approximately 40 percent of those diagnosed with diabetes did not achieve the blood sugar control target of A1C <7 percent recommended by the American Diabetes Association. The A1C test measures average blood glucose levels over the past two-to-three-month period.

About the Sanofi Diabetes Division
Sanofi strives to help people manage the complex challenges of diabetes by delivering innovative, integrated and personalized solutions. Driven by valuable insight that comes from listening to and engaging with people living with diabetes, the Company is forming partnerships to offer diagnostics, therapies, services, and devices. Sanofi markets both injectable and oral medications for people with type 1 or type 2 diabetes. Investigational compounds in the pipeline include an injectable GLP-1 agonist being studied as a single agent, in combination with basal insulins, and/or in combination with oral antidiabetic agents.

About Sanofi
Sanofi, a global and diversified 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, rare diseases, consumer healthcare, emerging markets and animal health. Sanofi is listed in Paris (EURONEXT: SAN) and in New York (NYSE: SNY).

1. Lower weight gain and better outcomes in patients with type 2 diabetes starting insulin treatment when baseline A1C <8 percent: Abstract No: 670

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