Zemidapa Adverse Reactions

For further information on adverse effects associated with the gemigliptin and dapagliflozin, refer to the appropriate individual monographs.
Summary of the safety profile: In a 24-week study in type 2 diabetes mellitus patients who had inadequate blood glucose control in combination with metformin and dapagliflozin, gemigliptin 50 mg or placebo was administered once daily as an add-on combination. Table 1 summarizes the most common (≥1.0% of patients) adverse events reported in this study. (See Table 1.)

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The 24-week add-on combination therapy was extended through 52-week with gemigliptin 50 mg added on to stable dose of metformin and dapagliflozin. The new adverse events that occurred in 2 or more patients (1.30%) during the latter 28 weeks when compared with the first 24 weeks, regardless of assessment of causality, were hyperglycemia (0% vs 1.30%) and headache (0% vs. 1.30%).
In a 24-week study in type 2 diabetes mellitus patients who had inadequate blood glucose control on metformin alone, dual add-on therapy with gemigliptin 50 mg and dapagliflozin 10 mg or each add-on therapy with gemigliptin 50 mg or dapagliflozin 10 mg was administered once daily. Table 2 summarizes the most common (≥1.0% of patients) adverse events reported in this study. (See Table 2.)

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Description of selected adverse reactions: Hypoglycemia: In a 24-week study in which gemigliptin 50 mg or placebo was administered once daily in patients with combination of metformin and dapagliflozin, hypoglycemia was reported in 1 patient (0.63%) in the gemigliptin 50 mg group. The hypoglycemia experienced by the patient in the clinical trial was at level 1 (hypoglycemic alert value) in severity and fully recovered, which was not related to gemigliptin 50 mg administration. During the latter 28 weeks in the extended 52-week study of gemigliptin 50 mg, 2 patients (1.30%) reported hypoglycemia. Two patients (1 patient (1 case) with level 1 and 1 patient (1 case) with level 2 (clinically significant hypoglycemia)) recovered during the clinical trial, which was not related to gemigliptin 50 mg administration.
In a 24-week study in which dual add-on therapy with gemigliptin 50 mg and dapagliflozin 10 mg or each add-on therapy with gemigliptin 50 mg or dapagliflozin 10 mg was administered once daily in patients on metformin, hypoglycemia was reported in 4 subjects (2.58%) in the dual add on therapy with gemigliptin 50 mg and dapagliflozin 10 mg group. All of the hypoglycemic levels were at level 1 (hypoglycemic alert value), and all of which except 1 case were reported to be related to gemigliptin 50 mg and dapagliflozin 10 mg, but all of the 4 subjects were recovered during the study period.