A diabetes treatment being co-developed by Indianapolis-based Eli Lilly and Co. (NYSE: LLY) is showing promising results in trials. An investigational combination tablet has demonstrated reduced blood glucose levels in adults with type 2 diabetes. June 15, 2014

News Release

RIDGEFIELD, Conn. and INDIANAPOLIS, Ind. – Two phase III clinical trials found the investigational combination tablet of empagliflozin and linagliptin reduced blood glucose levels in adults with type 2 diabetes (T2D), Boehringer Ingelheim Pharmaceuticals, Inc. (BIPI) and Eli Lilly and Company (NYSE: LLY) announced. The findings were presented as late breaking abstracts today at the American Diabetes Association 74th Scientific Sessions. The 24-week primary findings of these two 52-week trials compared the combination of empagliflozin and linagliptin with empagliflozin or linagliptin alone in patients with T2D and moderately elevated blood glucose levels consistent with what is often seen in clinical practice.

“We are encouraged by the reductions in blood glucose levels with the empagliflozin/linagliptin combination tablet and by the fact that more than half of the 494 adults with type 2 diabetes in these studies were able to achieve blood glucose goals below 7.0 percent with the combination,” said Christophe Arbet-Engels, M.D., Ph.D., vice president, metabolic clinical development and medical affairs, BIPI. “People with type 2 diabetes must often take more than one medication to adequately control their blood sugar levels. If approved, this combination tablet with two mechanisms of action that lower A1C through different pathways in a single pill could be an important treatment option for physicians and patients.”

If approved, this investigational combination would bring together the distinct mechanisms of action of a sodium glucose co-transporter-2 (SGLT2) inhibitor and a dipeptidyl peptidase-4 (DPP-4) inhibitor for the first time in one tablet. SGLT2 inhibitors remove excess glucose through the urine by blocking blood glucose re-absorption in the kidney. DPP-4 inhibitors work by increasing hormones that stimulate the pancreas to produce more insulin and stimulate the liver to produce less glucose.

Investigational empagliflozin/linagliptin combination in adults with T2D with moderate hyperglycemia at baseline (mean baseline of 8.0 percent) who were taking metformin

This 52-week study of 686 randomized adults with T2D examined the change from baseline of hemoglobin A1C (a measure of average blood glucose over the past two to three months) at 24 weeks. Adults in this study had a mean baseline A1C of 8.0 percent.

Both empagliflozin/linagliptin combination doses showed statistically significant reductions in A1C vs. the empagliflozin component dose or linagliptin alone.

Statistically significantly more adults who had A1C levels of 7.0 percent or more at baseline achieved A1C levels less than 7.0 percent after 24 weeks with both doses of the empagliflozin/linagliptin combination versus either empagliflozin or linagliptin alone.

Empagliflozin 25 mg/linagliptin 5 mg: 61.8 percent

Empagliflozin 10 mg/linagliptin 5 mg: 57.8 percent

Empagliflozin 25 mg: 32.6 percent

Empagliflozin 10 mg: 28.0 percent

Linagliptin 5 mg: 36.1 percent

For adults who had A1C levels of 8.5 percent or greater at baseline, the following reductions in A1C were seen.

The empagliflozin 25 mg/linagliptin 5 mg combination reduced A1C by 1.8 percent, compared with 1.2 percent for empagliflozin 25 mg.

The empagliflozin 10 mg/linagliptin 5 mg combination reduced A1C by 1.6 percent, compared with 1.3 percent for empagliflozin 10 mg.

Linagliptin 5 mg alone reduced A1C by 1.0 percent.

The empagliflozin/linagliptin combinations resulted in weight loss similar to that of empagliflozin monotherapy.

Empagliflozin 25 mg/linagliptin 5 mg: body weight reduction of 3.0 kg from a mean baseline of 85.5 kg

Empagliflozin 10 mg/linagliptin 5 mg: body weight reduction of 2.6 kg from a mean baseline of 86.6 kg

Empagliflozin 25 mg: body weight reduction of 3.2 kg from a mean baseline of 87.7 kg

Empagliflozin 10 mg: body weight reduction of 2.5 kg from a mean baseline of 86.1 kg

Adverse events (AEs) were reported in 54.7 percent of subjects on the empagliflozin 25 mg/linagliptin 5 mg combination, 54.4 percent of subjects on the empagliflozin 10 mg/linagliptin 5 mg combination, 63.1 percent of subjects on empagliflozin 25 mg, 57.1 percent of subjects on empagliflozin 10 mg and 54.5 percent of subjects on linagliptin 5 mg. Confirmed hypoglycemic AEs were reported in two subjects each on the empagliflozin 25 mg/linagliptin 5 mg combination (1.5 percent), the empagliflozin 10 mg/linagliptin 5 mg combination (1.5 percent), empagliflozin 10 mg (1.4 percent) and linagliptin 5 mg (1.5 percent), and four on empagliflozin 25 mg (2.8 percent); none required assistance.

Investigational empagliflozin/linagliptin combination in treatment-na?ve adults with T2D with moderate hyperglycemia at baseline (mean baseline of 8.0 percent)

This 52-week study of 677 adults with T2D who were treatment-na?ve examined the reduction in A1C from baseline at 24 weeks. As with the metformin study, adults in this study had moderate hyperglycemia (mean A1C of 8.0 percent) at baseline.

A1C reduction with the empagliflozin 25 mg/linagliptin 5 mg combination was not statistically significantly greater than that of empagliflozin 25 mg.

A1C reduction with the empagliflozin 10 mg/linagliptin 5 mg combination was significantly greater than that of empagliflozin 10 mg alone.

Compared with linagliptin 5 mg, both combination doses significantly reduced A1C and body weight.

Significantly more adults who had A1C levels of 7.0 percent or more at baseline achieved A1C levels less than 7.0 percent after 24 weeks with both doses of the empagliflozin/linagliptin combination versus the empagliflozin component dose or linagliptin alone.

Empagliflozin 25 mg/linagliptin 5 mg: 55.4 percent

Empagliflozin 10 mg/linagliptin 5 mg: 62.3 percent

Empagliflozin 25 mg: 41.5 percent

Empagliflozin 10 mg: 38.8 percent

Linagliptin 5 mg: 32.3 percent

AEs were reported in 58.8 percent of subjects on the empagliflozin 25 mg/linagliptin 5 mg combination, 63.2 percent of subjects on the empagliflozin 10 mg/linagliptin 5 mg combination, 57.8 percent of subjects on empagliflozin 25 mg, 62.2 percent of subjects on empagliflozin 10 mg and 64.4 percent of subjects on linagliptin 5 mg. Confirmed hypoglycemic AEs were reported in two subjects (1.5 percent) on empagliflozin 25 mg and one each (0.7 percent) on empagliflozin 10 mg and linagliptin 5 mg; none required assistance. No confirmed hypoglycemic events were reported for patients randomized to empagliflozin/linagliptin combinations.

About Empagliflozin

Empagliflozin is an investigational sodium glucose co-transporter-2 (SGLT2) inhibitor and is being studied for the reduction of blood glucose levels in adults with diabetes. The emerging SGLT2 inhibitor class removes excess glucose through the urine by blocking glucose re-absorption in the kidney. Empagliflozin is being studied in one of the largest clinical registration programs in its class, comprised of more than 10 multinational clinical trials and more than 13,000 adults with T2D.

About Linagliptin

Linagliptin, which is marketed as Tradjenta (linagliptin) tablets in the U.S., is a once-daily, 5-mg tablet used along with diet and exercise to improve glycemic control in adults with T2D. TRADJENTA should not be used in patients with type 1 diabetes or for the treatment of diabetic ketoacidosis. TRADJENTA has not been studied in patients with a history of pancreatitis.

Source: Eli Lilly and Co.

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