Ozempic (Semaglutide) Is Not Approved for Type 1 Diabetes and Should Not Be Used in This Population
Ozempic (semaglutide) is not approved for use in type 1 diabetes and should not be used in this population due to safety concerns, particularly the increased risk of diabetic ketoacidosis (DKA). 1
FDA Approval Status and Contraindications
The FDA label for Ozempic clearly states its limitations of use:
- Ozempic is indicated only for adults with type 2 diabetes mellitus
- Ozempic is not a substitute for insulin
- Ozempic is not indicated for use in patients with type 1 diabetes mellitus 1
- Ozempic is not indicated for treatment of diabetic ketoacidosis, as it would not be effective in these settings 1
Evidence from Clinical Guidelines
The American Diabetes Association (ADA) Standards of Care (2025) acknowledges that while some non-insulin medications have been studied in type 1 diabetes, they are not FDA-approved for this indication:
GLP-1 Receptor Agonists in Type 1 Diabetes:
Safety Concerns with SGLT2 Inhibitors:
Approved Adjunctive Therapies for Type 1 Diabetes
Currently, the only FDA-approved adjunctive therapy to insulin for type 1 diabetes is:
- Pramlintide: An injectable amylin analogue that delays gastric emptying, blunts pancreatic secretion of glucagon, and enhances satiety 2
- When pramlintide is used, prandial insulin dosing should be reduced to minimize the risk for severe hypoglycemia 2
Emerging Research
While there is emerging interest in using GLP-1 receptor agonists in type 1 diabetes:
- A recent review (2025) indicates that semaglutide and tirzepatide are not currently approved for type 1 diabetes treatment 3
- The review acknowledges that these medications may serve as potential add-on treatments to insulin in patients with type 1 diabetes, particularly those with features of "double diabetes" (type 1 diabetes with insulin resistance and/or obesity) 3
- However, this remains investigational and not supported by robust clinical trials or regulatory approval
Potential Risks of Off-Label Use
Using Ozempic in type 1 diabetes carries several risks:
- Diabetic Ketoacidosis: GLP-1 RAs may mask symptoms of hyperglycemia while not providing sufficient insulin, potentially leading to DKA
- Hypoglycemia: When combined with insulin therapy, there's an increased risk of hypoglycemia
- Gastrointestinal Side Effects: Nausea, vomiting, and diarrhea are common with semaglutide 4
- Retinopathy Complications: Rapid improvement in glycemic control with semaglutide may worsen existing diabetic retinopathy 2
Conclusion
Based on the current FDA labeling and clinical guidelines, Ozempic (semaglutide) should not be used in patients with type 1 diabetes. The standard of care for type 1 diabetes remains insulin therapy, with pramlintide as the only approved adjunctive therapy. While research continues to explore potential benefits of GLP-1 RAs in specific type 1 diabetes populations, their use remains investigational and not supported by regulatory approval.