INDIANAPOLIS, May 8, 2020 /PRNewswire/ -- New 36-week data showed higher investigational doses of Trulicity (3 mg and 4.5 mg) were well-tolerated and led to A1C reductions up to 1.9 percent and weight reductions up to 10.4 pounds in people with type 2 diabetes. Juan Pablo Frias, M.D., Medical Director and Principal Investigator, National Research Institute. The 4.5 mg dose led to statistically superior A1C reductions from baseline compared to Trulicity 1.5 mg across two primary statistical approaches - efficacyi and treatment-regimenii estimands - that were used to assess the efficacy of the higher doses. Across both estimands, the majority of study participants achieved target A1C goals of less than seven percent with the higher investigational doses - meeting the American Diabetes Association's recommendation for people with diabetes. The safety and tolerability profile of the investigational dulaglutide doses (3 mg and 4.5 mg) was consistent with the known profile of Trulicity 1.5 mg. The most commonly reported adverse events across each of the doses were gastrointestinal-related.

Dawn Brooks, Ph.D., global development leader, Trulicity, Lilly. Results at 52-weeks were consistent with the 36-week results and further details will be disclosed at a later date. The AWARD-11 results have been submitted to regulatory authorities in the U.S. The phase 3, randomized, double-blind, parallel arm study included 1,842 participants with type 2 diabetes and evaluated the efficacy and safety of two investigational doses of dulaglutide (3 mg and 4.5 mg) compared to Trulicity 1.5 mg. The primary objective of the study was to demonstrate that a once-weekly investigational dulaglutide dose (3 mg and/or 4.5 mg) was superior to the approved Trulicity 1.5 mg dose, as measured by A1C reduction from baseline, at 36 weeks in people with inadequately controlled type 2 diabetes on concomitant metformin therapy. The primary and secondary objectives could be met if one or both doses achieved statistical significance for the endpoints. Secondary and exploratory outcomes included change from baseline in mean body weight and fasting serum glucose (FSG), percentage of patients reaching an A1C goal of less than seven percent and occurrence of hypoglycemic episodes and pharmacokinetics at steady-state through 36 and 52 weeks.

All participants started the study at a dose of Trulicity 0.75 mg once-weekly and then increased the dose in a step-wise approach at four week intervals to their final randomized maintenance dose of once-weekly 1.5 mg, 3 mg (via a 1.5 mg step) or 4.5 mg (via steps at 1.5 mg and 3 mg). Important Facts About Trulicity® (Trῡ-li-si-tee). It is also known as dulaglutide. TRULICITY is an injectable prescription medicine for adults with type 2 diabetes used to improve blood sugar (glucose) and used to reduce the risk of major cardiovascular events such as death, heart attack, or stroke in people who have heart disease or multiple cardiovascular risk factors. You take it once a week by injecting it under the skin of your stomach, thigh, or upper arm. Use Trulicity together with the diet and exercise that your doctor recommends. Trulicity is not insulin. Trulicity may cause tumors in the thyroid, including thyroid cancer. Watch for possible symptoms, such as a lump or swelling in the neck, trouble swallowing, hoarseness, or shortness of breath.

If you have a symptom, tell your doctor. Do not use Trulicity if you or any of your family have ever had a type of thyroid cancer called medullary thyroid carcinoma (MTC). Do not use Trulicity if you are allergic to dulaglutide or other ingredients in Trulicity. Inflamed pancreas (pancreatitis). Stop using Trulicity and call your healthcare provider right away if you have severe pain in your stomach area (abdomen), with or without vomiting, that will not go away. You may feel the pain from your abdomen to your back. Changes in vision. Tell your healthcare provider if you have changes in vision during treatment with Trulicity. Low blood sugar (hypoglycemia). Signs and symptoms of low blood sugar may include dizziness or light-headedness, confusion or drowsiness, headache, blurred vision, slurred speech, fast heartbeat, MedicGLP sweating, hunger, shakiness, feeling jittery, weakness, anxiety, irritability or mood changes. Serious allergic reactions. Stop using Trulicity and get medical help right away if you have any symptoms of a serious allergic reaction which may include: swelling of your face, lips, tongue or throat, problems breathing or swallowing, severe rash or itching, fainting or feeling dizzy, or very rapid heartbeat.

Acute kidney injury. In people who have kidney problems, diarrhea, nausea, and vomiting may cause a loss of fluids (dehydration). This may cause kidney problems to get worse. Severe stomach problems. Trulicity may cause stomach problems, which could be severe. The most common side effects of Trulicity include nausea, diarrhea, vomiting, abdominal pain and decreased appetite. These are not all the possible side effects of Trulicity. Tell your doctor if you have any side effects. Your healthcare provider should show you how to use Trulicity before you use it for the first time. Before you use Trulicity, talk to your doctor about low blood sugar and how to manage it. Do you have other medical conditions, including problems with your pancreas, kidneys, liver, or stomach, or have a history of diabetic retinopathy? Do you take other diabetes medicines, such as insulin or sulfonylureas? Do you take any other prescription medicines or over-the-counter drugs, vitamins or herbs? Review the list below with your doctor.