Chronic and progressive type 2 diabetes affects over 30 million patients in the US. Its consequences can be severe, with blindness, kidney failure, cardiovascular disease, and death included as possible outcomes. The increased risk for these ancillary conditions is directly attributed to chronic hyperglycemia damaging blood vessels, tissues, and organs. Glycemic control is the most prevalent goal for type 2 diabetes treatments. A new first-in-class drug approval is making it possible to improve blood sugar control while keeping the risk of hypoglycemia from increasing insulin doses at bay.

The novel therapy just approved in May 2022 is Mounjaro (tirzepatide) injection. The drug is indicated for improved blood sugar control in adults with type 2 diabetes, as an addition to diet and exercise. It is a unique therapy referred to as a dual agonist, as it contains both a glucose-dependent insulinotropic polypeptide (GIP) receptor and glucagon-like peptide-1 (GLP-1) receptor agonist. Tirzepatide selectively binds to and activates both receptors, which are the targets for native GIP and GLP-1. It increases insulin secretion and insulin sensitivity and reduces glucagon levels. It is delivered subcutaneously and will be available in 2.5mg, 5mg, 7.5mg, 10mg, 12.5mg, and 15mg doses. The recommended starting dose of 2.5mg once weekly is for treatment initiation and is not intended for glycemic control. After 4 weeks of the starting dose, the 5mg once weekly dose may be started. The dosage may be increased in 2.5mg increments after at least 4 additional weeks if additional glycemic control is needed, up to a maximum dosage of 15mg once weekly.

Tirzepatide was evaluated through five clinical trials where its efficacy was compared to a placebo, a GLP-1 receptor agonist, and two long-acting insulin analogs. The new drug’s performance in these clinical studies showed it to be more effective than the therapies compared to it. Some adverse effects are possible with tirzepatide and include nausea, vomiting, diarrhea, decreased appetite, constipation, upper abdominal discomfort, and abdominal pain. While the drug does not have an indication at this time for weight loss, the studies conducted did track the average change in body weight as a secondary endpoint. The average weight loss was between 12 and 25 pounds and extended to up to 52 pounds. This signals that the drug may have the potential to be an obesity treatment for patients with or without diabetes. Presently, published data for tirzepatide includes patients who have type 2 diabetes, but as stated in a review published in April 2022 in The Journal of Clinical Endocrinology & Metabolism, the new therapy “has the potential to meet the criteria for a second-generation drug for the general treatment of obesity once data become available in non-diabetic patients.”

The results of the clinical studies, the recent novel FDA approval, and the continued trials underway that may demonstrate extended health benefits related to improved cardiovascular outcomes or weight loss are all exciting occurrences for healthcare providers treating patients with type 2 diabetes and for those individuals coping with the disease. Stay informed about emergent drug information, including treatment options for type 2 diabetes, by updating or registering your profile to receive email alerts and other critical drug information updates from PDR. You can also stay current by using the official PDR app, mobilePDR, available for free from your favorite app stores.