Novel type 2 diabetes medication mounjaro gets FDA approval
MDlinx Jun 23, 2022
The US Food and Drug Administration (FDA) recently approved Mounjaro, also known as tirzepatide, for adults with type 2 diabetes.
Mounjaro is an injectable prescription medication meant to be used alongside diet and exercise to improve blood sugar control.
Initial findings indicate this medication could be an invaluable asset in treating your adult patients with type 2 diabetes.
Why it was approved
The approval of Mounjaro was based on results from the phase 3 SURPASS program, which compared it to competitors such as injectable semaglutide, insulin glargine, and insulin degludec.
"Mounjaro delivered superior and consistent A1C reductions against all of the comparators throughout the SURPASS program, which was designed to assess Mounjaro's efficacy and safety in a broad range of adults with type 2 diabetes who could be treated in clinical practice,“ said Juan Pablo Frías, MD, Medical Director, National Research Institute and Investigator in the SURPASS program, in a press release.
FDA approves Lilly’s Mounjaro™ (Tirzepatide) injection, the first and only GIP and GLP-1 receptor agonist for the treatment of adults with type 2 diabetes. Cision PR Newswire. May 13, 2022.
The approval of Mounjaro is an exciting step forward for people living with type 2 diabetes, given the results seen in these clinical trials.
Mechanism of action
Glucagon-like peptide-1 (GLP-1) and glucose-dependent insulinotropic polypeptide (GIP) are hormones involved in blood glucose control. GLP-1 receptor agonists work by stimulating insulin secretion during hyperglycemic episodes.
Frías JP, Davies MJ, Rosenstock J, et al. Tirzepatide versus semaglutide once weekly in patients with type 2 diabetes. N Engl J Med. 2021;385(6):503–515.
GLP-1 receptor agonists also suppress glucagon secretion, delay gastric emptying, suppress appetite, and reduce body weight. Unlike GLP-1, GIP is glucagonotropic. In the presence of high blood sugar, GIP stimulates insulin release and lowers glucagon levels. Under low blood sugar conditions, GIP leads to an increase in glucagon levels.
Mounjaro is a first-in-class medication that acts as a dual GIP–GLP-1 receptor agonist.
Its structure is based on the GIP amino acid sequence. It has a half-life of approximately 5 days that allows under-the-skin injections once a week.
Efficacy of Mounjaro
Five clinical trials evaluated the efficacy of Mounjaro, when administered at three different doses (5 milligrams, 10 milligrams, and 15 milligrams).
FDA approves novel, dual-targeted treatment for type 2 diabetes. FDA. May 13, 2022.
The trials administered Mounjaro either as a stand-alone therapy or as an add-on to other diabetes medications. Mounjaro was compared to placebo, semaglutide (a GLP-1 receptor agonist), and two long-acting insulin analogs.
Patients who were randomly assigned to receive 15 milligrams of Mounjaro as a stand-alone therapy decreased their hemoglobin A1c (HbA1c) by 1.6% more than the placebo. When used in combination with a long-acting insulin, they lowered their HbA1c by 1.5% more than the placebo.
Clinical trials comparing Mounjaro to other FDA-approved diabetes medications were also promising.
Patients receiving the maximum dose of Mounjaro lowered their HbA1c by 0.5% more than semaglutide, 0.9% more than insulin degludec, and 1.0% more than insulin glargine.
The clinical trials also demonstrated significant weight reductions among study participants who received Mounjaro compared to other diabetes medications. The average BMI of study participants was 32 to 34 kilograms/height in meters squared.
Patients who received the maximum dosage of Mounjaro lose an average of 15 pounds more than the placebo as a stand-alone therapy and 23 pounds more than the placebo when used in combination with insulin.
Average weight loss of patients receiving 15 milligrams of Mounjaro was 12 pounds more than semaglutide, 29 pounds more than insulin degludec, and 27 pounds more than insulin glargine.
Mounjaro safety
The most common side effects of Mounjaro include nausea, diarrhea, vomiting, decreased appetite, constipation, and abdominal pain.
Studies have shown that Mounjaro can cause thyroid C-cell tumors in rats. However, it’s unclear whether Mounjaro causes similar tumors, including medullary thyroid cancer, in humans.
Mounjaro should not be used by patients with a history (personal or family) of medullary thyroid cancer, or patients with Multiple Endocrine Neoplasia syndrome type 2.
Mounjaro is not indicated for use in patients with type 1 diabetes, and has not been studied in patients with a history of pancreatitis.
What this means for you
Type 2 diabetes medication Mounjaro has shown promising results in clinical trials comparing it to other diabetes medications. Mounjaro has led to significant improvements in A1c and weight loss. Healthcare providers should discuss its benefits and potential side effects with type 2 diabetes patients. Dosing must be monitored by a healthcare provider to aid patients in meeting their blood sugar and weight loss goals.
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