Summary of the safety profile: There were 1,468 patients with type 2 diabetes, including 1,080 patients treated with gemigliptin, randomized in 5 double-blind and 1 open-label controlled clinical safety and efficacy studies conducted to evaluate the effects of gemigliptin on glycemic control.
The overall incidence of adverse events in patients treated with gemigliptin was similar to placebo and active-control group.
Discontinuation of therapy due to adverse events was similar in patients who received gemigliptin as compared to placebo (1.4% as compared to 0.8%).
Across all the clinical studies, there was no serious adverse event (SAE) related to gemigliptin.
Tabulated list of adverse reactions: Because clinical trials are conducted under widely varying conditions, adverse reaction rates observed in the clinical trials of a drug cannot be directly compared to rates in the clinical trials of another drug and may not reflect the rates observed in practice.
The table presents adverse reactions which have been reported during 6 randomized, controlled clinical studies. The adverse reactions are listed by SOC (system organ class) and PT (Preferred Term) with frequency. Frequencies are defined as Very common (≥1/10), Common (≥1/100 to <1/10), Uncommon (≥1/1,000 to <1/100), Rare (≥1/10,000 to <1,000), not known (cannot be estimated from the available data). (See table.)
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Description of selected adverse reactions: Hypoglycemia: In six randomized controlled studies of gemigliptin, 15 patients (1.4%) reported hypoglycemia. The hypoglycemia experienced by patients in clinical trials was considered mostly of mild in intensity and patients fully recovered.
Hypersensitivity: In the active-controlled add-on combination study (gemigliptin as add-on to metformin therapy), two patients (1.71%) receiving 25 mg gemigliptin twice daily on a stable dose of metformin in the first 24-weeks and 50 mg once daily in the latter 28 weeks reported anaphylactic reactions, which was not related to gemigliptin (see Contraindications and Precautions).