Indicated as an adjunct to diet and exercise to improve glycemic control in adults with type 2 diabetes.
Safety data from RYBELSUS® clinical trials
Safety and tolerability of RYBELSUS® was evaluated across 10 different clinical trials1-3,a


The most frequently reported adverse reactions were GI disorders, including nausea, abdominal pain, and diarrhea

Nausea, vomiting, and/or diarrhea occurred mostly during dose escalation

4% and 8% of patients discontinued RYBELSUS® 7 mg and 14 mg, respectively, due to GI adverse reactions, compared to 1% of patients receiving placebo
GI=gastrointestinal.



Incidence of severe hypoglycemia was ≤1%b

Hypoglycemia was more frequent when RYBELSUS® was used in combination with insulin secretagogues (eg, sulfonylurea) or insulin
- Patients may require a lower dose of the secretagogue or insulin to reduce the risk of hypoglycemia in this setting



A cardiovascular outcomes trial (CVOT) compared RYBELSUS® added to standard of care vs placebo added to standard of care

Primary endpoint was the time to first occurrence of a 3-part composite outcome of major adverse cardiovascular events (MACE), which included cardiovascular death, nonfatal myocardial infarction, and nonfatal stroke

The total number of primary component MACE endpoints was 137 (61 [3.8%] with RYBELSUS® and 76 [4.8%] with placebo)
CV=cardiovascular.
aIncluding 1 monotherapy trial and 1 trial in combination with insulin.1
b“Severe” hypoglycemia adverse reactions are episodes requiring the assistance of another person.

Adverse reactions in placebo-controlled trials reported in ≥5% of RYBELSUS®-treated patients1,c


cExcluding hypoglycemia.
In the pool of placebo- and active-controlled trials, the types and frequency of common adverse reactions, excluding hypoglycemia, were similar to those listed in the table above.
From:

A double-blind trial with a primary endpoint of change in A1C at 26 weeks, in 703 patients with type 2 diabetes inadequately controlled with diet and exercise1,5

A double-blind trial with a primary endpoint of change in A1C at 26 weeks, in 731 patients with type 2 diabetes inadequately controlled on insulin (basal, basal/bolus, or premixed) with or without metformin1,6
PIONEER 4 adverse events vs liraglutide 1.8 mg4


Data are n (%).
dOccurring in more than 5% of participants in any treatment group, categorized by preferred term (Medical Dictionary for Regulatory Activities, version 20.1).
Explore the RYBELSUS® clinical trials
RYBELSUS® went head-to-head with the most prescribed DPP-4i, SGLT-2i, and an injectable GLP-1 RA.1,3

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