How Mounjaro May Fit Into the Type 2 Diabetes Treatment Journey
Sherwin D’Souza, MD, FACE: Hello and welcome! I’m Dr. Sherwin D’Souza, an endocrinologist in Boise, Idaho. Today I’m joined by Ms. Ellen Neylon and Dr. Eugene Wright, who are here to share their insights and experiences with type 2 diabetes and Mounjaro. Could you each please tell us a little bit about yourself?
Ellen Neylon, MSN, FNP-BC, RN: I’m Ellen Neylon, and I’m a nurse practitioner in an endocrinology practice in Las Vegas, Nevada.
Eugene E. Wright, Jr, MD: And I’m Eugene Wright. I work as a primary care physician in North Carolina.
Dr. D’Souza: Thank you. I’m excited to talk with both of you today, but first let’s review the Indication and Boxed Warning for Mounjaro.
Mounjaro is indicated as an adjunct to diet and exercise to improve glycemic control in adults with type 2 diabetes mellitus.
Mounjaro also has a Boxed Warning related to the risk of thyroid C-cell tumors.
In both male and female rats, tirzepatide causes dose-dependent and treatment-duration-dependent thyroid C-cell tumors at clinically relevant exposures. It is unknown whether Mounjaro causes thyroid C-cell tumors, including medullary thyroid carcinoma (MTC), in humans as the human relevance of tirzepatide-induced rodent thyroid C-cell tumors has not been determined.
Mounjaro is contraindicated in patients with a personal or family history of MTC or in patients with Multiple Endocrine Neoplasia syndrome type 2 (MEN 2). Counsel patients regarding the potential risk for MTC with the use of Mounjaro and inform them of symptoms of thyroid tumors (for example, a mass in the neck, dysphagia, dyspnea, persistent hoarseness). Routine monitoring of serum calcitonin or using thyroid ultrasound is of uncertain value for early detection of MTC in patients treated with Mounjaro.
Now let’s dive right in and talk through our different approaches to type 2 diabetes management. Dr. Wright, what does early treatment of patients with type 2 diabetes mean to you, and why is it important?
Dr. Wright: To me, someone with early type 2 diabetes has a new onset of the disease and is recently diagnosed. To treat in a manner consistent with guidelines, such patients require “early and intensive” treatment to prevent long-term complications. I’m not a fan of the stepwise “treat-to-failure” approach, as I think it exposes the patient to excess glycemia over time.
Dr. D’Souza: I agree. Historically, we’ve followed a reactive approach, and that’s how I used to practice. I would start the patient on one medication, monitor their glycated hemoglobin, or A1C, and then add or adjust therapy once the A1C started to rise. But this reactive approach is now outdated, and I’ve changed the way I practice. Now I follow a more proactive approach because, as you noted, the guidelines say that if you treat patients early in their disease, then down the road it may help them delay or even avoid certain complications altogether.
Ms. Neylon: That’s an important point. When a patient comes to me with a new diagnosis of type 2 diabetes, I like to talk to them about how they have a chronic disease, one that is manageable and treatable but also one that is advancing and potentially going to get worse with time. By starting treatment early, you can make an impact on your patient’s disease and potentially on common associated comorbidities of type 2 diabetes.
Dr. Wright: I completely agree. In the southeastern United States, where I practice, many of our patients come in with a type 2 diabetes diagnosis and have a family history of diabetes. A common phrase we hear is, “I only have a little touch of sugar,” and I have to try to disabuse them of that notion. There’s no such thing as “a touch of sugar.” Type 2 diabetes is a serious disease, and, as recommended by the guidelines, therapy should be started promptly at the time type 2 diabetes is diagnosed.
Ms. Neylon: Right. And I also think it’s important to meet your patients where they are in their type 2 diabetes treatment journey.
Dr. Wright: Exactly.
Dr. D’Souza: And what is meant by “early” in type 2 diabetes is also relative to when you’re seeing the patient. In our practice, for example, we only see patients by referral, so they may be on 2 or 3 antihyperglycemic medications without reaching their glycemic target before they are sent to me. Is that similar to your experience?
Ms. Neylon: Like you, I also work in an endocrinology practice. I often see patients with a longer duration of type 2 diabetes who have tried multiple therapies, but I do occasionally see newly diagnosed patients as well.
Dr. Wright: In the primary care space where I operate, it’s very different. Patients may come in because they have symptoms or know they have a family history of diabetes, or they may come in for something entirely different, and type 2 diabetes may not be the first, second, or third thing on their mind.
Dr. D’Souza: Such interesting insights. Thank you for sharing. Can you touch on how you discuss treatment options for type 2 diabetes with your patients?
Ms. Neylon: When patients come in, I like to discuss all of the type 2 diabetes treatment options I have in my toolbox. I talk with them about how we want to work toward their individualized goals from the start, regularly reassessing their progress and not delaying treatment modifications if they are not meeting their individualized treatment goals. I want my patients to achieve their glycemic goals as soon as possible, so I recommend using higher-efficacy therapies that have a greater likelihood of helping them achieve those goals.
Dr. D’Souza: That’s similar to my approach; we’re both following the guidelines. When patients come to me, they often have a fear of starting certain treatments, and they may feel they have failed themselves or disappointed their primary care doctor. Often no one has discussed treatment options with them, so I talk to them about what’s available. I really like a shared decision-making approach; I think it improves adherence. I’ve always believed that the best way to get a patient to stay on any drug is to explain to them not only how the drug works but also the potential risks and benefits, and allow them to be involved in the final choice of therapy.
Dr. Wright: Agreed. We know that type 2 diabetes is a progressive disease that requires lifelong treatment. For us to have success as clinicians, we want patients to buy into the therapy and understand why they’re taking it, so they’re more likely to stay on that therapy.
Dr. D’Souza: And that’s the perfect setup to shift the focus of our conversation to Mounjaro, a glucose-dependent insulinotropic polypeptide, or GIP, and glucagon-like peptide-1, or GLP-1, receptor agonist. Mounjaro is one of the medications we have in our toolbox to treat adults with type 2 diabetes, so when and why do each of you consider Mounjaro for your patients?
Dr. Wright: For me, it’s easier to determine who’s not an appropriate candidate for Mounjaro. Keeping in mind individual patient characteristics and safety considerations, I aim to start Mounjaro early after type 2 diabetes diagnosis, once I’ve determined it is an appropriate treatment choice.
Ms. Neylon: I echo what you’re saying. Mounjaro is on my list of go-tos for adult patients with type 2 diabetes. Unless there is something in the medical history or a rationale against it, I believe it would be a missed opportunity to not offer Mounjaro as a treatment option for appropriate patients. In fact, there’s no limitation in the label about using Mounjaro as a first-line therapy, which is why I like to use it early after type 2 diabetes diagnosis.
Dr. D’Souza: And Mounjaro isn’t a specialty medication, so it’s not only endocrinologists who can prescribe Mounjaro. Many adults with type 2 diabetes who are struggling with glycemic control and have excess weight may be appropriate candidates for Mounjaro. I’m always cautious with medications, so I first make sure the patient doesn’t have any contraindications or other important safety concerns that may prevent them from trying Mounjaro, like a personal or family history of medullary thyroid cancer. I also ask them about their type 2 diabetes journey: what medicines they’ve been on, whether they’ve previously taken a GLP-1 receptor agonist, and, if so, whether they’ve had any side effects. I’ll often educate them about how Mounjaro is different from a GLP-1 receptor agonist, as it activates 2 receptors instead of 1: GLP-1 and GIP. I’ll explain the differences to them and, if appropriate, I’ll tell them that Mounjaro may be worth a try.
And, like you, Dr. Wright, I also consider Mounjaro early after type 2 diabetes diagnosis as well as at other times during a patient’s type 2 diabetes treatment journey.
Dr. Wright: I like to think about what the best treatment for the patient is and what will help them meet their goals. Mounjaro often comes up because we have a lot of people with type 2 diabetes who struggle with control of their glucose and have excess body weight.
Ms. Neylon: I agree. When Mounjaro is used in conjunction with diet and exercise, I’ve seen many adult patients with type 2 diabetes improve their glycemic control and also reduce excess weight.
Dr. Wright: That reminds me of a patient I had. A young woman came into my office with relatively new-onset type 2 diabetes and overweight, and we were faced with a choice of what treatment to initiate. I told her about Mounjaro and how it may be a treatment option that could help her. Based on the clinical data, I told my patient, “Mounjaro may lower your blood glucose, it could help you lose some weight, and it’s a once-weekly injection.” To my surprise, the injection part didn’t bother her, and she wanted to try it. I initiated her on a 2.5-milligram starting dose once weekly, then after 4 weeks increased her treatment to the 5-milligram dose. We escalated her dose over time, increasing Mounjaro by 2.5 milligrams in 4-week intervals as needed. She made lifestyle changes, her A1C improved, and she had some weight reduction.
Ms. Neylon: That’s a great story, Dr. Wright, and I’d like to add that I’ve had many patients who don’t mind taking injections, so I don’t hesitate to prescribe injectables early on in a patient’s type 2 diabetes journey. It’s so nice to hear my observations match another clinician’s experiences with Mounjaro. I don’t always see patients right after their diagnosis, but I’ve seen Mounjaro work for patients with type 2 diabetes of various durations. I had a woman with type 2 diabetes come in who was on multiple antihyperglycemic medications but still had uncontrolled A1C. After evaluating her type 2 diabetes treatment regimen and starting her on Mounjaro, her A1C began decreasing over time. For me it was a real win to see positive results in a patient who had been struggling to reach her glycemic goal.
Dr. D’Souza: I’ve had similar experiences with Mounjaro and have seen how it can help patients reach their treatment goals.
Dr. Wright: And in an endocrinology practice, I would imagine that if they’re being referred to you, they’ve already tried several therapies with varying degrees of success.
Dr. D’Souza: Right, and I appreciate what Mounjaro has done for many of my patients. I had an adult patient with type 2 diabetes come in who was struggling with rising A1C, excess weight, and wanting to be more active. This patient was on multiple different medications, and I certainly could have started basal insulin at that point. But keeping in mind the patient’s goals of lowering her A1C and reducing excess weight, we discussed starting Mounjaro. So she started on 2.5 milligrams of Mounjaro for 4 weeks, then escalated to 5 milligrams of Mounjaro. Over time on the 5-milligram dose, her A1C had dropped below target and her weight was down. At that point we discussed the fact that there are higher doses, but she was pleased with her existing response to Mounjaro. I was happy with her A1C improvement and pleased with the weight she had lost, so I chose to leave her on the 5-milligram dose. Over time I’ve continued to see her, and I’ve maintained her at that same 5-milligram dose of Mounjaro and she’s still doing very well.
I tend not to escalate doses rapidly because I have seen success with the 5-milligram dose. When a patient is no longer seeing the same effect with the 5-milligram dose, I want to have plenty of room to escalate their dosage.
Ms. Neylon: I agree. As providers we have to make sure that we’re not just dialing it up because the doses are available, but rather escalating the dose of Mounjaro as needed for glycemic control.
Dr. Wright: It’s just variations on the same theme: figure out what the treatment targets are, consider which medications may be appropriate, and come up with a treatment plan that has the potential to help the patients reach their individual treatment goals.
Dr. D’Souza: Thank you both for sharing your thoughts and for the engaging conversation.
To follow up on our discussion about Mounjaro, I want to share efficacy and safety results from the SURPASS phase 3 registrational trials.
The effectiveness of Mounjaro as an adjunct to diet and exercise to improve glycemic control in adults with type 2 diabetes was established in 5 trials. A similar study design was used in each trial. Patients were randomized to receive Mounjaro 5, 10, or 15 milligrams, placebo, or an active comparator.
In trials that allowed background glucose-lowering therapy, various combinations of metformin, SGLT2 inhibitors, a sulfonylurea, and titrated insulin glargine were permitted. Comparator treatments included placebo, Ozempic® 1 milligram, titrated Tresiba®, and titrated insulin glargine.
The primary endpoint across the SURPASS studies was the mean change in A1C from baseline at 40 or 52 weeks. Mounjaro delivered superior A1C reductions across the range of background therapies and comparators studied.
Similarly, for the key secondary endpoint of mean change in weight from baseline, Mounjaro consistently demonstrated greater weight reductions versus comparators. As a reminder, Mounjaro is not indicated for weight loss.
In the pool of placebo-controlled studies, adverse reactions reported in at least 5% of patients taking Mounjaro included nausea, diarrhea, decreased appetite, vomiting, constipation, dyspepsia, and abdominal pain.
In placebo-controlled trials, when Mounjaro was used as a monotherapy, 0% of patients in the Mounjaro treatment groups reported hypoglycemia or severe hypoglycemia. In the placebo group, the incidence of hypoglycemia was 1% and the incidence of severe hypoglycemia was 0% after 40 weeks.
In placebo-controlled trials, when Mounjaro was used as an add-on to basal insulin with or without metformin, the incidence of hypoglycemia after 40 weeks in patients receiving Mounjaro 5, 10, or 15 milligrams ranged from 14 to 19% and was 13% for placebo. The incidence of severe hypoglycemia ranged from 0 to 2% in the Mounjaro groups, with no reported incidence for placebo.
Thanks for joining us today.
[Select Important Safety Information]
Contraindications
Mounjaro is contraindicated in patients with a personal or family history of MTC or in patients with MEN 2, and in patients with known serious hypersensitivity to tirzepatide or any of the excipients in Mounjaro. Serious hypersensitivity reactions including anaphylaxis and angioedema have been reported with Mounjaro.
Risk of Thyroid C-cell Tumors
Counsel patients regarding the potential risk for MTC with the use of Mounjaro and inform them of symptoms of thyroid tumors (for example, a mass in the neck, dysphagia, dyspnea, persistent hoarseness). Routine monitoring of serum calcitonin or using thyroid ultrasound is of uncertain value for early detection of MTC in patients treated with Mounjaro. Such monitoring may increase the risk of unnecessary procedures, due to the low test specificity for serum calcitonin and a high background incidence of thyroid disease. Significantly elevated serum calcitonin values may indicate MTC and patients with MTC usually have calcitonin values greater than 50 nanograms per liter. If serum calcitonin is measured and found to be elevated, the patient should be further evaluated. Patients with thyroid nodules noted on physical examination or neck imaging should also be further evaluated.
Acute Pancreatitis
Acute pancreatitis, including fatal and non-fatal hemorrhagic or necrotizing pancreatitis, has been observed in patients treated with GLP-1 receptor agonists, or Mounjaro. Observe patients for signs and symptoms, including persistent severe abdominal pain sometimes radiating to the back, which may or may not be accompanied by vomiting. If pancreatitis is suspected, discontinue Mounjaro and initiate appropriate management.
Hypoglycemia with Concomitant Use of Insulin Secretagogues or Insulin
Concomitant use with an insulin secretagogue (for example, sulfonylurea) or insulin may increase the risk of hypoglycemia, including severe hypoglycemia. The risk of hypoglycemia may be lowered by reducing the dose of sulfonylurea (or other concomitantly administered insulin secretagogue) or insulin. Inform patients using these concomitant medications of the risk of hypoglycemia and educate them on the signs and symptoms of hypoglycemia.
Hypersensitivity Reactions
Serious hypersensitivity reactions (for example, anaphylaxis and angioedema) have been reported in patients treated with Mounjaro. If hypersensitivity reactions occur, discontinue use of Mounjaro; treat promptly per standard of care, and monitor until signs and symptoms resolve. Do not use in patients with a previous serious hypersensitivity to tirzepatide or any of the excipients in Mounjaro. Use caution in patients with a history of angioedema or anaphylaxis with a GLP-1 receptor agonist because it is unknown if such patients will be predisposed to these reactions with Mounjaro.
Acute Kidney Injury Due to Volume Depletion
There have been postmarketing reports of acute kidney injury, in some cases requiring hemodialysis, in patients treated with GLP-1 receptor agonists, or Mounjaro. The majority of reported events occurred in patients who experienced gastrointestinal adverse reactions leading to dehydration such as nausea, vomiting, or diarrhea. Monitor renal function in patients reporting adverse reactions to Mounjaro that could lead to volume depletion, especially during dosage initiation and escalation of Mounjaro.
Severe Gastrointestinal Adverse Reactions
Use of Mounjaro has been associated with gastrointestinal adverse reactions, sometimes severe. In the pool of placebo-controlled trials, severe gastrointestinal adverse reactions occurred more frequently among patients receiving Mounjaro (5 milligrams 1.3%, 10 milligrams 0.4%, 15 milligrams 1.2%) than placebo (0.9%). Mounjaro is not recommended in patients with severe gastroparesis.
Diabetic Retinopathy Complications in Patients with a History of Diabetic Retinopathy
Rapid improvement in glucose control has been associated with a temporary worsening of diabetic retinopathy. Mounjaro has not been studied in patients with non-proliferative diabetic retinopathy requiring acute therapy, proliferative diabetic retinopathy, or diabetic macular edema. Patients with a history of diabetic retinopathy should be monitored for progression of diabetic retinopathy.
Acute Gallbladder Disease
In clinical trials, acute gallbladder disease was reported by 0.6% of Mounjaro-treated patients and 0% of placebo-treated patients. If cholelithiasis is suspected, gallbladder diagnostic studies and appropriate clinical follow-up are indicated.
Pulmonary Aspiration During General Anesthesia or Deep Sedation
Mounjaro delays gastric emptying. There have been rare postmarketing reports of pulmonary aspiration in patients receiving GLP-1 receptor agonists undergoing elective surgeries or procedures requiring general anesthesia or deep sedation who had residual gastric contents despite reported adherence to preoperative fasting recommendations. Instruct patients to inform healthcare providers prior to any planned surgeries or procedures if they are taking Mounjaro.
Adverse Reactions
The most common adverse reactions reported in greater than or equal to 5% of Mounjaro-treated patients in placebo-controlled trials were nausea, diarrhea, decreased appetite, vomiting, constipation, dyspepsia, and abdominal pain.
Drug Interactions
When initiating Mounjaro, consider reducing the dose of concomitantly administered insulin secretagogues (such as sulfonylureas) or insulin to reduce the risk of hypoglycemia. Mounjaro delays gastric emptying, and thereby has the potential to impact the absorption of concomitantly administered oral medications, so caution should be exercised.
Pregnancy
Limited data on Mounjaro use in pregnant women are available to inform on drug-associated risk for major birth defects, miscarriage, or other adverse maternal or fetal outcomes. Based on animal reproduction studies, there may be risks to the fetus from exposure to tirzepatide. Use only if potential benefit justifies the potential risk to the fetus.
Lactation
There are no data on the presence of tirzepatide in human milk, the effects on the breastfed infant, or the effects on milk production. The developmental and health benefits of breastfeeding should be considered along with the mother’s clinical need for Mounjaro and any potential adverse effects on the breastfed infant from Mounjaro or from the underlying maternal condition.
Females of Reproductive Potential
Advise females using oral hormonal contraceptives to switch to a non-oral contraceptive method, or add a barrier method of contraception for 4 weeks after initiation and for 4 weeks after each dose escalation.
Pediatric Use
Safety and effectiveness of Mounjaro have not been established and use is not recommended in pediatric patients.
Please see the Full Prescribing Information, including Boxed Warning about possible thyroid tumors, including thyroid cancer, and Medication Guide by clicking the links within www.mounjaro.lilly.com/hcp.
Please see Instructions for Use included with the pen.
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