• The novel investigational sodium-glucose cotransporter 2 inhibitor empagliflozin demonstrated 90 weeks of sustained glycemic control and weight loss in patients with type 2 diabetes. Study researcher Thomas Hach, MD, a senior medical director at Boehringer Ingelheim, spoke withEndocrine Today about the data presented during a late-breaking session here.

“We feel there is an important obligation for us to understand patient benefits: to look at benefit-risks and to really understand which patients will benefit most or where there could possibly be limitations,” Hach said.

In active-control studies, Hach told Endocrine Today that he and colleagues saw comparable efficacy. They conducted a randomized, open-label, 78-week extension study on empagliflozin (Boehringer Ingelheim/Eli Lilly and Company).

They investigated empagliflozin 10 mg (n=81), 25 mg (n=82) or metformin (n=80) as monotherapy, or empagliflozin 10 mg (n=71), 25 mg (n=70) or sitagliptin (n=71; Januvia, Merck) as add-on to metformin in patients with type 2 diabetes who also completed one of two 12-week randomized control trials.

According to 90-week data, adjusted mean changes in HbA1c from baseline were: –0.51% (empagliflozin 10 mg), –0.60% (empagliflozin 25 mg) and –0.64% (metformin); and –0.61% (empagliflozin 10 mg), –0.74% (empagliflozin 25 mg) and –0.45% (sitagliptin).

Further data indicate adjusted mean changes in fasting plasma glucose were: –32.4 mg/dL (empagliflozin 10 mg), –28.1 mg/dL (empagliflozin 25 mg), and –25.9 mg/dL (metformin); –23.3 mg/dL (empagliflozin 10 mg), –31.8 mg/dL (empagliflozin 25 mg), and –11.7 mg/dL (sitagliptin).

Moreover, changes in weight were reported as: –2.1 kg (empagliflozin 10 mg), –1.9 kg (empagliflozin 25 mg), and –0.9 kg (metformin); –2.9 kg (empagliflozin 10 mg), –3.8 k (empagliflozin 25 mg), and –0.6 kg (sitagliptin).

“If I was still in clinical practice, I would look forward to having something new in my armamentarium. Unfortunately, there’s still a huge unmet need in diabetes,” Hach said.

The medication was well tolerated, and the most common adverse events associated with empagliflozin include urinary tract and genital infections. Hach said clinicians should use caution with elderly patients or those with renal impairment because those patients are more susceptible to adverse events.

In March, a new drug application for empagliflozin was submitted to the FDA. Further data will be presented at the American Diabetes Association Scientific Sessions in Chicago next month, Hach said. – by Samantha Costa

For more information:

Ferrannini E. Abstract #1102. Presented at: the AACE Annual Scientific and Clinical Congress; May 1-5, 2013; Phoenix.

Source: Endocrine today