Incidence of hypoglycemia with glimepiride/metformin fixed-dose combination in patients with type 2 diabetes inadequately controlled on metformin monotherapy in Peru: a prospective, active pharmacovigilance cohort study Short running title: Hypoglycemia with glimepiride plus metformin in Peru

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Purpose — To evaluate hypoglycemia incidence rate during treatment with a fixed-dose combination of glimepiride and metformin in patients non-responders to metformin monotherapy. Data were collected during customary specialized practice in Peru where access to effective and safe, but low-cost medications, is needed. Methods— This was an observational, prospective, active pharmacovigilance, cohort study with in-person medical assessments. Medical assessments were conducted every 3-months, with monthly follow-up through phone calls. Data regarding use and administration of treatment were recorded by patients. Adverse events (AE) reported by patients and/or ascertained by attending physicians during the period of 18 months along with treatment-related events were identified. Cumulative incidence and hypoglycemia incidence rate were estimated. Poisson and logistic regression models were applied to study their relationship with risk factors and patterns of use. Results— 206 patients were enrolled in the study from 10 centers and were followed for a median duration of 12 months (range, 2-18 months). Forty treatment-related AEs were reported (cumulative incidence = 19.4%). No severe hypoglycemic events were observed. Most common AE found was non-severe hypoglycemia (cumulative incidence = 2.4%; incidence rate = 2.6/100 person/years). Self-administration of a higher dose than prescribed was associated with a higher probability of an AE (p=0.03). Conclusions— Administration of a fixed-dose combination of glimepiride plus metformin was associated with low incidence of non-severe hypoglycemia, and no incidence of severe hypoglycemia. These results advocate the use of fixed-dose combination of glimepiride plus metformin in low- and middle-income countries with limited resources, even more so in wake of COVID-19 pandemic.

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