Once-weekly Trulicity 0.75 mg shows promising results in Japanese patients with type 2 diabetes

Eli Lilly and CompanyJun 7 2015

Results from a new study of Japanese patients with type 2 diabetes showed once-weekly Trulicity^™ 0.75 mg provided greater hemoglobin A1c (A1C) reduction compared to once-daily Victoza^® 0.9 mg after 52 weeks of treatment. Eli Lilly and Company (NYSE: LLY) will present these data at the 75^th American Diabetes Association (ADA) Scientific Sessions in Boston.

"These data not only reinforce once-weekly Trulicity as a safe and efficacious GLP-1 receptor agonist, but further support the value for Japanese patients, with greater A1C reductions compared to once-daily Victoza," said Jessie Fahrbach, M.D., medical director, Lilly Diabetes. "We are pleased to present these study findings, which capture important information about a key region where type 2 diabetes is on the rise."

The study's primary objective was met, with Trulicity 0.75 mg demonstrating a greater A1C reduction from baseline compared to placebo at 26 weeks. At the final endpoint of 52 weeks, which is the focus of the data presentation at the meeting, Trulicity 0.75 mg demonstrated statistically greater A1C reductions compared to Victoza 0.9 mg, the highest approved dose in Japan (-1.39 percent vs. -1.19 percent). Additional results showed:

• Trulicity 0.75 mg provided statistically greater reductions in the average self-monitored blood glucose levels compared to Victoza 0.9 mg (-53.1 mg/dL vs. -46.8 mg/dL); and
• Trulicity 0.75 mg significantly lowered average post-meal blood glucose levels from baseline compared to Victoza 0.9 mg (-63.7 mg/dL vs. -55.4 mg/dL).

Mean body weight did not change in either treatment group.

Both Trulicity and Victoza were well-tolerated in the study. No cases of adjudicated pancreatitis were reported, and no new safety signals were seen. The most frequently reported adverse events were gastrointestinal-related with Trulicity 0.75 mg and Victoza 0.9 mg, including:

• constipation (7.9 percent vs. 8 percent),
• diarrhea (7.1 percent vs. 4.4 percent),
• nausea (6.1 percent vs. 8 percent),
• abdominal distension (4.3 percent vs. 5.1 percent), and
• decreased appetite (0.7 percent vs. 5.8 percent). Reports of decreased appetite were significantly different between the two treatments.

Total hypoglycemia incidence in both treatment groups was 2.9 percent, with no severe hypoglycemia reported.

Japan currently ranks tenth in the world in the number of people with diabetes – an estimated 7.2 million cases. According to the International Diabetes Federation, the overall prevalence of diabetes in the Western Pacific region is expected to increase over the next 20 years. By 2035, an estimated 202 million people in the region will have diabetes, a 46 percent increase from 2014.

A regulatory application for Trulicity in Japan is pending. Trulicity was approved by the U.S. Food and Drug Administration (FDA) in September 2014, and launched in the U.S. in November 2014. The European Commission granted marketing authorisation for Trulicity in November 2014, and launches are ongoing in the various countries.