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 1. (See Table 1.)

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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 2. (See Table 2.)

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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 patients (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 3. (See Table 3.)

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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 patients (2.2%).
Hypoglycemia: In the 24-week monotherapy and combination therapy study with evogliptin 5 mg, hypoglycemia was each reported in one patient (monotherapy 1.3%, combination therapy 0.9%). All reported hypoglycemia cases were mild in severity and resolved without any action taken.
Vital signs: No clinically significant change in vital signs was observed in patients treated with Suganon.
Bullous pemphigoid: There have been postmarketing reports of bullous pemphigoid requiring hospitalization in patients taking other DPP-4 inhibitors.