Higher investigational doses of Trulicity® (dulaglutide) meaningfully reduced A1C and body weight in people with type 2 diabetes
"AWARD-11 confirmed our expectations that a higher investigational dose of Trulicity would lead to superior blood glucose and weight reductions in people with type 2 diabetes compared to Trulicity 1.5 mg," said
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.
Using the efficacy estimand, which analyzes participants who remained on treatment, dulaglutide 3 mg and 4.5 mg led to significantly superior A1C and weight reductions from baseline compared to Trulicity 1.5 mg:
(baseline 8.6 percent)
[baseline 211.4 lbs. (95.9 kg)]
dulaglutide 4.5 mg
-10.4 lbs. (-4.7 kg)*
dulaglutide 3 mg
-8.8 lbs. (-4.0 kg)*
Trulicity 1.5 mg
-6.8 lbs. (-3.1 kg)
*Denotes statistical significance compared to Trulicity 1.5 mg
In the treatment-regimen estimand, each of the doses led to significant A1C and body weight reductions but only the 4.5 mg dose showed superiority compared to Trulicity 1.5 mg:
- A1C reduction: -1.8 percent (dulaglutide 4.5 mg), -1.6 percent (dulaglutide 3 mg) and -1.5 percent (Trulicity 1.5 mg).
- Weight reduction: -10.1 pounds (-4.6 kg, dulaglutide 4.5 mg), -8.4 pounds (-3.8 kg, dulaglutide 3 mg) and -6.6 pounds (-3.0 kg, Trulicity 1.5 mg).
Across both estimands, the majority of study participants achieved target A1C goals of less than seven percent with the higher investigational doses – meeting the
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.
"Diabetes is a complex condition that progresses over time and may require additional treatments to maintain blood glucose control. That's why we studied higher doses of Trulicity, the most prescribed GLP-1 receptor agonist in the
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
About the AWARD-11 Study
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).
PURPOSE AND SAFETY SUMMARY WITH WARNINGS
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 have Multiple Endocrine Neoplasia syndrome type 2 (MEN 2).
- Do not use Trulicity if you are allergic to dulaglutide or other ingredients in Trulicity.
Ask your doctor how to recognize the serious side effects below and what to do if you think you have one:
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, 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.
Common side effects
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. You can report side effects at 1-800-FDA-1088 or www.fda.gov/medwatch.
- 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.
Review these questions with your doctor:
- 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. Trulicity may not be right for you if:
- You are pregnant or plan to become pregnant or breastfeeding or plan to breastfeed.
- You have type 1 diabetes or diabetic ketoacidosis.
- You have or have had an inflamed pancreas (pancreatitis).
- You have severe intestinal or stomach problems, such as slowed emptying or problems with digesting food.
- You are a child under 18 years old.
How to take
- Read the Instructions for Use that come with Trulicity.
- Use Trulicity exactly as your doctor says.
- Do not share your Trulicity pen, syringe or needles with another person.
- Do not give Trulicity to other people.
- If you take too much Trulicity, call your healthcare provider or seek medical advice promptly.
For more information, call 1-844-TRU-INFO (1-844-878-4636) or go to www.TRULICITY.com.
This summary provides basic information about Trulicity but does not include all information known about this medicine. Read the information that comes with your prescription each time your prescription is filled. This information does not take the place of talking with your doctor. Be sure to talk to your doctor or other healthcare provider about Trulicity and how to take it. Your doctor is the best person to help you decide if Trulicity is right for you.
Trulicity® is a registered trademark owned or licensed by
DG CON BS FEB2020
Approximately 34 million Americans1 (just over 1 in 10) and an estimated 463 million adults worldwide2 have diabetes. Type 2 diabetes is the most common type internationally, accounting for an estimated 90 to 95 percent of all diabetes cases in
Trulicity® is a registered trademark owned or licensed by
This press release contains forward-looking statements (as that term is defined in the Private Securities Litigation Reform Act of 1995) about dulaglutide 3 mg and/or 4.5 mg as a potential treatment for people with type 2 diabetes and reflects
1 Centers for Disease Control and Prevention. National Diabetes Statistics Report, 2020.
2 International Diabetes Federation. IDF Diabetes Atlas, 9th edn.
i The efficacy estimand was used to evaluate results in participants who stayed on treatment and did not start another diabetes medicine throughout the trial.
ii The treatment-regimen estimand, conducted based on regulatory guidance, includes data from all participants through the end of the trial, which may include confounding effects of rescue medication or discontinuation from the study drug or the trial.
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