Lilly Combo Tablet For Diabetes Reduced Blood Glucose

Eli Lilly & Co. and partner Boehringer Ingelheim announced that the investigational combination tablet of empagliflozin and linagliptin was able to reduce blood glucose levels in adults with type 2 diabetes (T2D) in two Phase II trials.

Empagliflozin is an investigational sodium glucose co-transporter-2 (SGLT2) inhibitor that works to remove excess glucose through the urine by inhibiting glucose re-absorption in the kidney. The drug is under investigation in a large clinical registration program involving over 13,000 adult patients with T2D.

Linagliptin (brand name Tradjenta) is a once-daily 5-mg tablet used as an adjunct to diet and exercise for the improvement of glycemic control in adults with T2D.

The 52 week study involving 686 patients compared the joint therapy of empagliflozin and linagliptin against empagliflozin or linagliptin alone in patients with T2D and moderately elevated blood glucose levels. The study found that the combination treatment achieved statistically significant reductions in blood glucose compared to either monotherapy at 24 weeks. For patients who have not undergone prior treatment, empagliflozin 10 mg/linagliptin 5 mg combination tablet showed significant reductions in baseline blood glucose levels compared with either monotherapy. The company also reported that reductions seen with empagliflozin 25 mg/linagliptin 5 mg failed to reach statistical significance compared with empagliflozin 25 mg.

Christophe Arbet-Engels, vice president of metabolic clinical development and medical affairs at Boehringer Ingelheim, said, “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… 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, the investigational combo treatment will unite the different mechanisms of action of a SGLT2 inhibitor and a dipeptidyl peptidase-4 (DPP-4) inhibitor for the first time in a single tablet.

T2D affects around 24.4 million patients in the U.S. and approximately 382 million people worldwide. The disease is a chronic condition in which the body fails to produce or use the hormone insulin properly.

The two companies announced their alliance to study treatments in diabetes in January 2011. Eli Lilly also recently launched its Annual Diabetes Summer Camp Tour in the U.S. featuring NASCAR Nationwide Series (NNS) driver Ryan Reed and Olympic cross-country skier Kris Freeman for children with Type 1 diabetes.