engleski

Linagliptin (LINA) as Add-on to Empagliflozin (EMPA) and Metformin in Patients with Type 2 Diabetes (T2DM): Subgroup Analysis by Baseline Demographics in Two 24-Week Randomized, Double Blind, Parallel-Group Trials

The efficacy and safety of LINA 5 mg vs. placebo (PBO) as add-on to EMPA10 mg or EMPA 25 mg and Metformin in patients with T2DM were assessed in two Phase III studies. Patients with HbA1c ≥ 8.0 and ≤ 10.5% while receiving stable-dose Metformin received open-label EMPA 10 mg (study 1 ; n=352)or EMPA 25 mg (study 2 ; n=354) for 16 weeks. Subsequently, patients with HbA1c ≥7.0 and ≤10.5% were randomized to 24 weeks’ double- blind, double dummy treatment with a single-pill combination of LINA 5 mg/EMPA 10 mg (n=126) or PBO + EMPA 10 mg (n=130) in study 1, and a single-pill combination of LINA 5 mg/EMPA 25 mg (n=114) or PBO + EMPA 25 mg (n=112) in study 2. LINA 5 mg signifi cantly reduced HbA1c from baseline (randomization) vs. PBO at week 24 (primary endpoint). Changes in HbA1c were analyzed in subgroups by baseline age, HbA1c, body mass index (BMI), and renal function (estimated glomerular fi ltration rate [eGFR)]. At week 24, LINA 5 mg was associated with improvements in HbA1c vs. PBO as add-on to EMPA 10 mg or 25 mg and Metformin in all subgroups of patients with T2DM. On Metformin background, LINA 5 mg as add-on to EMPA 10 mg or EMPA 25 mg improved glycemic control vs. PBO as add-on to EMPA 10 mg or EMPA 25 mg for 24 weeks irrespective of baseline age, BMI, HbA1c, and eGFR in patients with T2DM.

Linagliptin (LINA) ; Empagloflozin (EMPA) ; Metformin ; T2DM ; subgroup analys

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