They’re all over the news: Ozempic ®. Trulicity ®. Jardiance ®. Mounjaro ™. And more.
These drugs are all approved for glucose control in type 2 diabetes (T2D). Some of them also have additional indications reflecting their demonstrated benefits for cardiovascular disease, kidney health, and obesity.
None of these drugs are currently approved for glucose control in people with type 1 diabetes (T1D). However, a recent consensus report addressed the growing interest in GLP-1 receptor agonists as an adjunctive therapy for T1D and their “potential to improve glycemic and metabolic outcomes without increasing the risk of severe hypoglycemia or diabetic ketoacidosis.”
Let’s examine GLP-1 therapies and SGLT inhibitors and consider how drugs like Ozempic may one day help people with type 1 diabetes.
GLP-1 therapies
GLP-1 (glucagon-like peptide-1) receptor agonists work in multiple ways to control blood glucose and obesity. They block the release of glucagon, stimulate insulin production, slow the rate at which your stomach empties, and increase the sensation of feeling full. They are usually injected, but oral versions are available.
In people with T2D, this class of drugs lowers blood sugar levels and, for most people, causes weight loss. GLP-1 therapies have also been shown to reduce the risk of long-term cardiovascular complications often experienced by people with T2D, such as heart attack and stroke.
GLP-1 drugs include Ozempic/Rybelsus/Wegovy (semaglutide), Trulicity (dulaglutide), Victoza (liraglutide), and Mounjaro (tirzepatide), among others.
When GLP-1 treatments hit the market in the early 2000s, Breakthrough T1D and others funded several clinical trials to test whether GLP-1 receptor agonists, in addition to insulin, improved outcomes for people with type 1 diabetes. While some of these studies showed that the addition of GLP-1 therapies to insulin led to improvements in HbA1c, total insulin dose, and weight, the benefits were relatively modest and accompanied by some side effects like hypoglycemia (low blood sugar). As a result, these studies did not lead to GLP-1 receptor agonists being highly adopted for use by people with T1D.
However, these trials were done with older GLP-1 drugs. We are investigating whether the newest, most advanced GLP-1 therapies (like Ozempic) will improve the health of people living with type 1 diabetes. (See below!)
Consensus report on safe use of GLP-1 medications in T1D
Despite the fact that GLP-1 receptor agonists (and dual GLP-1/GIP receptor agonists) are not FDA-approved for use in T1D for any indication, people with T1D are still able to access these drugs since they are approved to treat obesity and overweight. Until now, HCPs have not had clear guidance around safe use for this class of drugs in people living with T1D.
Thanks to the diaTribe Foundation, including co-authorship by Brynn Marks, M.D. (Senior Director of Medical Affairs), we now have a consensus report featuring recommended expert guidelines for how HCPs and people with T1D can safely use GLP-1 medications alongside insulin therapy. This includes considerations around insulin dosing and continuous glucose monitor (CGM) adjustments, ketone management, monitoring and mitigating side effects (especially gastrointestinal) and complications like eye disease, and more. The idea is to support safe, individualized care for people living with T1D who may benefit from these medications.
This report also provides an overview of evidence around benefits of GLP-1 medications in T1D populations based on real-world and clinical trial data. Ongoing and future large-scale clinical trials are needed to provide additional data supporting the use of these drugs in people with T1D. Until then, both HCPs and T1D community members have a tangible resource for important considerations around using GLP-1 drugs safely. Consensus reports are a key step in driving clinical adoption of these therapies if they become FDA-approved for T1D in the future, and Breakthrough T1D endorses this report alongside five international diabetes organizations.
If you are living with T1D, consider talking to your healthcare team about the potential benefits of GLP-1 medications and see if they could be a fit for you.
SGLT inhibitors
SGLT (sodium-glucose co-transporter) inhibitors are oral medications for people with T2D that lower blood sugar by preventing the kidneys from reabsorbing glucose, leading to the excretion of sugar through the urine.
In addition to improving blood sugar for people with and without T2D, these drugs also provide benefits such as weight loss, blood pressure reduction, and transformative benefits to the heart and kidneys.
SGLT drugs include Jardiance (empagliflozin), Farxiga (dapagliflozin), and Invokana (canagliflozin), among others. The SGLT inhibitors empagliflozin and dapagliflozin are approved to treat chronic kidney disease and heart failure, regardless of diabetes status.
Yet, increased risk of diabetic ketoacidosis (DKA) in people with T1D limits the use of these therapies to improve blood sugar management or reduce the risk of complications. A key Breakthrough T1D priority is to find ways to mitigate this risk so people with T1D can also take advantage of the benefits of SGLT inhibitors.
Breakthrough T1D-funded research in GLP-1 and SGLT therapies
Breakthrough T1D has a long history with GLP-1 medications like Ozempic. In the 1980s, Breakthrough T1D-funded researcher Pauline Kay Lund, Ph.D., was the first to clone the hormone glucagon and discover two new hormones, one of which was GLP-1.
Today, there is real-world evidence of GLP-1 receptor agonists improving the lives of people with type 1 diabetes.
Real-world evidence
Observational studies using historical patient data from electronic health records (not randomized clinical trials) that can give an idea if a drug might be beneficial or not for a certain indication.
Evidence demonstrates that semaglutide (Ozempic) or tirzepatide (Mounjaro) have the potential to lower A1c, increase time-in-range, and reduce the amount of daily insulin needed in people with T1D. More research is needed in this area. That’s where Breakthrough T1D comes in!
Most recently, the Breakthrough T1D-funded ADJUST-T1D clinical trial showed that, in people with T1D and obesity or overweight using an automated insulin delivery system, Ozempic can help manage both weight and blood sugar.
Additional Breakthrough T1D-funded research on GLP-1 and SGLT therapies is investigating the benefits of these drugs for people with T1D, including reducing the risk of common complications of type 1 diabetes like cardiovascular disease and kidney disease.
Snapshot of active clinical trials in GLP-1 and SGLT therapies
Here are a few examples of Breakthrough T1D-funded clinical trials in GLP-1 and SGLT therapies that are currently underway:
| Clinical Trial Name | Study Details |
|---|---|
| REMODEL T1D | Determine whether semaglutide (Ozempic) protects the kidneys in those living with T1D. |
| Triple Therapy in T1DM | Assess whether the addition of dapagliflozin (Farxiga) to semaglutide (Ozempic) and insulin improves glycemic control in those living with T1D. |
| SUGARNSALT | Determine the effectiveness and safety of sotagliflozin (Inpefa) in slowing kidney function decline in those living with T1D and moderate to severe diabetic kidney disease. |
| Dapagliflozin + Pioglitazone in T1D | Examine how adding dapagliflozin (Farxiga) and pioglitazone (Actos) to insulin therapy affects glucose control and ketone concentration in people living with T1D. |
Our commitment to improving lives
Breakthrough T1D strives to improve health outcomes in people living with type 1 diabetes. Insulin therapy alone is often not enough for people with T1D to achieve glucose and metabolic control. The use of adjunctive drugs that complement insulin therapy can help. Since the FDA has already approved these medications for treating other conditions, positive results from these clinical trials could speed up the adaptation of these therapies for people living with T1D.
Learn more about clinical trials and how they are advancing breakthroughs for the T1D community.
