New Data Show Lilly's Trulicity® (dulaglutide) in Combination with an SGLT-2 Inhibitor Improves Blood Sugar Control in People with Type 2 Diabetes

INDIANAPOLIS, Feb. 26, 2018 — Trulicity^® (dulaglutide) significantly improves A1C (average blood sugar concentration over two to three months) when added to ongoing treatment with a sodium-glucose co-transporter-2 (SGLT-2) inhibitor, according to results from AWARD-10, a new Phase 3b clinical study. These data were published online first in The Lancet Diabetes & Endocrinology. Trulicity is Eli Lilly and Company's (NYSE: LLY) once-weekly, injectable glucagon-like peptide-1 (GLP-1) receptor agonist approved to improve blood sugar (glucose) in adults with type 2 diabetes. Trulicity should be used along with diet and exercise.

"I've seen in my practice that even with effective oral medicines like SGLT-2 inhibitors and metformin, many adults with type 2 diabetes may still need additional therapy to maintain their blood sugar levels," said Bernhard Ludvik, M.D., associate professor of medicine, Rudolfstiftung Hospital Vienna and AWARD-10 lead author. "The AWARD-10 results suggest that the combination of once-weekly Trulicity and an SGLT-2 inhibitor shows significant promise in helping more people with type 2 diabetes reach their treatment goals."

At the study's primary endpoint of 24 weeks, both Trulicity 1.5 mg and 0.75 mg added to ongoing treatment with an SGLT-2 inhibitor demonstrated statistically superior glycemic control (-1.34 percent, -1.21 percent for Trulicity 1.5 mg and 0.75 mg, respectively) compared to an SGLT-2 inhibitor with placebo (-0.54 percent). Further, significantly more people in the Trulicity groups reached target A1C levels of less than 7 percent and less than or equal to 6.5 percent:

• Trulicity 1.5 mg: 71 percent ( < 7 percent); 50 percent (≤6.5 percent)
• Trulicity 0.75 mg: 60 percent ( < 7 percent); 38 percent (≤6.5 percent)
• Placebo: 32 percent ( < 7 percent); 14 percent (≤6.5 percent)

Additional results showed that Trulicity 1.5 mg combined with an SGLT-2 inhibitor was associated with greater average weight loss (-3.1 kg) compared to placebo (-2.1 kg). An average weight reduction of -2.6 kg was seen in the Trulicity 0.75 mg group.

The most commonly reported adverse events associated with Trulicity were gastrointestinal-related and consistent with previous studies. Nausea (15 percent, 5 percent, 4 percent), vomiting (4 percent, 3 percent, 1 percent) and diarrhea (6 percent, 10 percent, 3 percent) were more frequent in the Trulicity 1.5 mg and 0.75 mg groups compared to placebo. One severe hypoglycemic event was documented in the Trulicity 0.75 mg group. No new Trulicity-related safety concerns were identified.¹

"Managing type 2 diabetes with diet, exercise and oral medications may require the addition of injectable therapy for some people, given the progressive nature of the disease," said Brad Woodward, M.D., senior medical director, LillyDiabetes. "AWARD-10 showed that Trulicity, when used in combination with an SGLT-2 inhibitor and metformin, may be effective and well tolerated in people with type 2 diabetes."

About the AWARD-10 Study
The Phase 3b, double-blind, parallel-arm, placebo-controlled, 24-week AWARD-10 study compared the safety and efficacy of Trulicity 1.5 mg and 0.75 mg in combination with sodium glucose co-transporter-2 (SGLT-2) inhibitors to placebo plus SGLT-2 inhibitors in people with type 2 diabetes inadequately controlled with SGLT-2 inhibitors, with or without metformin. The primary objective of this study, in 424 patients in eight countries with a mean baseline A1C of 8.04 percent, was to demonstrate superiority of Trulicity plus an SGLT-2 inhibitor to placebo plus an SGLT-2 inhibitor on A1C reduction.

Indication and Limitations of Use for Trulicity^®
Trulicity is a once-weekly injectable prescription medicine to improve blood sugar (glucose) in adults with type 2 diabetes mellitus. It should be used along with diet and exercise. Trulicity is not recommended as the first medication to treat diabetes. It has not been studied in people who have had inflammation of the pancreas (pancreatitis). Trulicity should not be used by people with type 1 diabetes, people with diabetic ketoacidosis, or people with a history of severe gastrointestinal (GI) disease. It is not a substitute for insulin. It has not been studied in children under 18 years of age.