Suganon Adverse Reactions

Monotherapy: In the 12-week placebo-controlled monotherapy study using 2.5 mg, 5 mg, or 10 mg of SUGANON or placebo once daily, the adverse events reported with a frequency of 3% or higher are listed in Table 4. (See Table 4.)

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In the 24-week placebo-controlled monotherapy study using 5 mg of SUGANON or placebo once daily, the adverse events reported with a frequency of 3% or higher are listed in Table 5. (See Table 5.)

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In patients administering SUGANON 5 mg once daily as monotherapy for 52 weeks, the adverse events that occurred during the extension period (last 28 weeks) regardless of causality with increased frequency by 1% or higher compared to those of the 24-week study were toothache (3.1% vs. 1.3%) and contact dermatitis (3.1% vs. 1.3%). Compared to the 24-week study, there was no newly reported adverse event that occurred in two or more subjects (3.1%).
Combination therapy: In the 24-week active-drug-controlled combination therapy study with stable doses of metformin and either SUGANON 5 mg or sitagliptin 100 mg once daily, the adverse events reported with a frequency of 3% or higher are listed in Table 6. (See Table 6.)

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In the 52-week study using SUGANON 5 mg once daily combined with metformin, the adverse events that occurred during the extension period (last 28 weeks) regardless of causality with increased frequency by 1% or higher compared to those of the 24-week study were gastritis (2.2% vs. 0.9%) and upper respiratory tract infection (4.3% vs. 2.7%). Compared to the 24-week study, sciatica (2.2%) was a newly reported adverse event that occurred in two or more subjects (2.2%).
In the clinical trial in which SUGANON 5 mg or a placebo was additionally administered once daily for 52 weeks in patients with type 2 diabetes who have inadequate glycemic control with the stable doses of metformin and dapagliflozin combination therapy, the adverse events reported with a frequency of 1% or higher are listed in Table 7. (See Table 7.)

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Hypoglycemia: In the 24-week monotherapy and metformin combination therapy study with evogliptin 5 mg, hypoglycemia was each reported in one patient (monotherapy 1.3%, metformin combination therapy 0.9%). All reported hypoglycemia cases were mild in severity and resolved without any action taken. In the clinical trial in which SUGANON 5 mg or a placebo was additionally administered once daily for 52 weeks in patients with type 2 diabetes who have inadequate glycemic control with the stable doses of metformin and dapagliflozin combination therapy, hypoglycemia was each reported in one patient (evogliptin 5 mg 0.71%, placebo 0.71%). All were asymptomatic hypoglycemia, resolved during the study without any action taken and the causality was related.
Vital signs: No clinically significant change in vital signs was observed in patients treated with SUGANON.
Bullous pemphigoid: There have been post marketing reports of bullous pemphigoid requiring hospitalization in patients taking other DPP-4 inhibitors.
Post-marketing surveillance result: Post-marketing surveillance result for re-examination in Korea: In the post-marketing surveillance in 3,445 patients for 6 years for re-examination in Korea, the incidence of adverse events, regardless of causality, was 8.59% (296/3,445 patients, 355 cases in total). Of these events, both serious adverse drug reactions and unexpected adverse drug reactions, which the causal relationship with SUGANON could not be excluded, are listed in the following table, in the order of frequency. (See Table 8.)

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