A New Weekly GLP-1 Agonist for Type 2 PatientsThursday, October 23, 2014
The U.S. Food and Drug Administration has approved Trulicity (dulaglutide), a once-weekly, glucagon-like peptide-1 (GLP-1) receptor agonist by Lilly which is indicated as an adjunct to diet and exercise to improve blood sugar levels adults with type 2 diabetes.
Trulicity is the first ready-mixed comes as a single-dose pen, and does not require mixing nor measuring. It is administered once a week by subcutaneous injection in the abdomen, thigh or upper arm. It can be given at any time of day, independent of meals.
Trulicity which has a boxed warning for thyroid C-cell tumors has been studied as monotherapy and in combination with metformin, metformin and sulfonylurea, metformin and thiazolidinedione, and prandial insulin with or without metformin. Trulicity was compared to other therapies including Januvia (sitagliptin), Byetta (exenatide), and Lantus (insulin glargine).
Here is an image of a Trulicity (dulaglutide) 1.5 mg/0.5 mL single dose pen.
Results for the different studies were as follows:
• Trulicity produced comparable to significant reductions from baseline in HbA1c compared to comparator group
• More patients met HbA1c goal in the Trulicity groups compared to the comparator groups
• Reduction of fasting and 2-hour PPG concentrations was significant compared to placebo and were sustained after 6 weeks of dosing with the 1.5 mg Trulicity dose.
• Fasting glucose levels and weight were reduced more effectively with Trulicity (1.5mg) as opposed to comparator groups; however, fasting glucose level reduction was similar to insulin Lantus (glargine) vs Trulicity 1.5mg dose (26 week trial Glargine/Trulicity both in Combination with Insulin Lispro).
• Body weight was reduced more effectively in Trulicity (1.5mg) as opposed to comparator groups
• Hypoglycemia was more frequent when Trulicity was used in combination with a sulfonylurea or insulin
• Gastrointestinal side effects were the most common side effects in the Trulicity groups compared to comparator groups.
During the trials we learned that no dose adjustment is recommended in patients with renal impairment including end-stage renal disease (ESRD). Renal function however, should be monitored in patients with renal impairment reporting severe adverse gastrointestinal reactions. When initiating Trulicity in patients on secretagogues or insulin, consider reducing the dosage of concomitantly administered insulin secretagogues (e.g., sulfonylureas) or insulin to reduce the risk of hypoglycemia.
As a clinician, I feel overwhelmed by the number of GLP-1 agonists that come on the market. I often look for what distinguishes one GLP-1 agonist from another. To dispel the confusion, this medication brings benefits to patients who otherwise will not be able to visually determine if the crystals dissolve and mixed well in the solution, wait some time as required and then inject the mixed solution.
Studies have shown that it has an effect on fasting and postprandial glucose levels. In my mind, I can picture this product as an alternative to other GLP-1 agonists if the patient cannot tolerate another GLP-1 agonist. In addition, I can picture Trulicity as an alternative to improve fasting glucose levels in patient with erratic eating habits that will otherwise use of insulin glargine/lispro combinations and would be at risk for hypoglycemia.
Trulicity provides a convenient alternative to other GLP-1 receptor agonists including Tanzeum (albiglutide), Bydureon (exenatide LAR) which are also administered once weekly but requires mixing, and Victoza (liraglutide) which is administered once daily. I believe this new product provides more opportunity for patients with diabetes and providers to improve diabetes care.