Ozempic (Semaglutide) Use in Type 1 Diabetes
Ozempic (semaglutide) is not indicated for use in patients with type 1 diabetes mellitus as stated explicitly in the FDA label. 1
FDA Labeling and Contraindications
- Ozempic's FDA label clearly states: "OZEMPIC is not a substitute for insulin. OZEMPIC is not indicated for use in patients with type 1 diabetes mellitus or for the treatment of patients with diabetic ketoacidosis, as it would not be effective in these settings." 1
- The medication guide for patients reinforces this: "OZEMPIC is not a substitute for insulin and is not for use in people with type 1 diabetes or people with diabetic ketoacidosis." 1
Current Guidelines on Type 1 Diabetes Management
- The 2017 American Diabetes Association standards of medical care in diabetes classify GLP-1 receptor agonists like semaglutide as "investigational agents" for type 1 diabetes, not as approved treatments. 2
- Insulin remains the mainstay of treatment for patients with type 1 diabetes, with other treatments being supplementary rather than replacements. 2
Potential Risks and Concerns
- The FDA has issued warnings about sodium-glucose cotransporter-2 inhibitors (another class of medications sometimes used off-label in type 1 diabetes) leading to ketoacidosis, highlighting the risks of using non-insulin medications in type 1 diabetes. 2
- Pretreatment assessment for semaglutide is critical, as there are risks of thyroid and pancreatic disorders that require careful screening before initiation. 3
- Patients should be monitored for potential adverse effects including:
Emerging Research
- Recent research shows potential benefits of semaglutide in overweight or obese patients with type 1 diabetes:
- A 2024 retrospective study showed significant improvements in BMI (7.9% reduction), body weight (15.9 lbs reduction), HbA1c, and continuous glucose monitoring metrics in type 1 diabetes patients using semaglutide. 4
- The ADJUST-T1D trial (2025) demonstrated that in adults with type 1 diabetes and obesity using automated insulin delivery systems, semaglutide significantly improved time in glucose range and achieved at least 5% weight reduction in 36% of participants versus 0% in the placebo group. 5
- A 2025 real-world study showed 9.1% body weight loss and improved glucose control with semaglutide in type 1 diabetes patients after 1 year of off-label use. 6
Clinical Approach
- Despite emerging research showing potential benefits, the current FDA labeling and guidelines do not support the use of semaglutide in type 1 diabetes. 1, 2
- For patients with type 1 diabetes who are overweight or obese:
- Insulin remains the primary treatment 2
- Pramlintide is an FDA-approved adjunct to mealtime insulin for patients with type 1 diabetes who have not achieved blood glucose goals after optimizing insulin therapy 2
- If considering off-label use of semaglutide (which is not recommended per FDA labeling), patients would need:
Conclusion
While emerging research shows potential benefits of semaglutide in overweight or obese patients with type 1 diabetes, particularly for weight management and glycemic control, the current FDA labeling explicitly states that Ozempic is not indicated for use in type 1 diabetes. Until further large-scale clinical trials are completed and regulatory approval is obtained, insulin remains the cornerstone of type 1 diabetes management, with pramlintide as the only FDA-approved adjunctive therapy.