Claim substantiation review
Source page: Ozempic® HCP website (NovoMedLink), “Pen A1C & Weight” page. Accessed October 13, 2026.
Each claim was traced to its cited source, checked for accuracy and context, and annotated with the notes a Medical, Legal, or Regulatory reviewer would raise. References are renumbered from the original page.
| # | Claim (as written) | Ref | Location | Supported? | Reviewer note |
|---|---|---|---|---|---|
| 1 | The most common adverse reactions reported in ≥5% of patients treated with Ozempic® injection are nausea, vomiting, diarrhea, abdominal pain, and constipation | 1 | Ref 1 (PI): Highlights, Adverse Reactions; Section 6.1, Table 1 | Yes | Population differs from the SUSTAIN FORTE table above, but the claim is labeled ‘In placebo-controlled trials.’ No change needed. |
| 2 | Incidence of severe hypoglycemia was ≤1.5% across all placebo-controlled trials | 1 | Ref 1 (PI): Section 6.1, Table 2 | Yes | Supported by Table 2 (maximum 1.5%, Ozempic 1 mg added to basal insulin). Fair balance: Section 6.1 also reports severe hypoglycemia in 0.8% and 1.2% of patients on Ozempic 0.5 mg and 1 mg with a sulfonylurea. Consider adding context that hypoglycemia risk increases with insulin or sulfonylureas. |
| 3 | SUSTAIN FORTE Ozempic 1 mg vs 2 mg: mean change in A1C from baseline at Week 40 in patients with type 2 diabetes on metformin ± sulfonylurea | 1 | Ref 1 (PI): Section 14.1, Table 7 | Yes | Data supported by Section 14.1, Table 7 (primary endpoint). Trial name ‘SUSTAIN FORTE’ is not in the PI. Also cite the Frías paper for the trial name. |
| 4 | Gastrointestinal adverse reactions occurred more frequently among patients receiving Ozempic® injection 2 mg (34.0%) vs Ozempic injection 1 mg (30.8%) | 1, 2 | Ref 1 (PI): Section 6.1 (GI adverse reactions) Ref 2 (Frías 2021): Table 3 | Yes | “More frequently” is acceptable, but do not imply statistical significance; these values were not statistically compared. |
| 5 | SUSTAIN 4: Head-to-head vs Lantus® (insulin glargine U-100) | 1, 3 | Ref 1 (PI): Section 14.1, Table 6 Ref 3 (Aroda 2017): Section 2, Materials and Methods | Yes | Legal: the source does not name Lantus; determine appropriate trademark treatment. Medical: the trial was open-label. Head-to-head claims usually need that context nearby. |
| 6 | SUSTAIN 5: As an add-on to basal insulin vs placebo | 1, 4 | Ref 1 (PI): Section 14.1, Table 8 Ref 4 (Rodbard 2018): Materials and Methods | Yes | SUSTAIN 5 is not named in the PI. Cite Rodbard 2018, which names the trial. |
References
1. Ozempic® injection [package insert]. Plainsboro, NJ: Novo Nordisk Inc. Revised 05/2026.
2. Frías JP, et al. SUSTAIN FORTE. Lancet Diabetes Endocrinol. 2021;9(9):563-574.
3. Aroda VR, et al. SUSTAIN 4. Lancet Diabetes Endocrinol. 2017;5(5):355-366.
4. Rodbard HW, et al. SUSTAIN 5. J Clin Endocrinol Metab. 2018;103(6):2291-2301.
Independent practice exercise. Not affiliated with or endorsed by Novo Nordisk. Ozempic® is a registered trademark of Novo Nordisk A/S. Lantus® is a registered trademark of Sanofi.