Evaluate the efficacy and safety of CANA (SGLT2 inhibitor), in older subjects with T2DM using a pooled analysis. Pooled data from 4 randomized, placebo(PBO)-controlled, 26-week studies (n=2,313) were analyzed by age: <65 years (n=1868; male, 49.1%; mean age, 52.8 years) or ≥65 years (n=445; male, 51.5%; mean age, 69.3 years). CANA 100 mg and 300 mg reduced HbA1c, weight and systolic BP compared with PBO in subjects <65 and ≥65 years of age (Table 1); lipid changes were similar in both age groups. Overall adverse events (AEs) with CANA 100 mg and 300 mg and PBO in subjects <65 years were 59.9%, 59.0% and 58.9% and those ≥65 years were 61.0%, 60.4% and 61.3%. Serious AEs and AE-related discontinuations were similar with CANA 100 mg and 300 mg and PBO in subjects <65 years (serious AEs: 2.5%, 2.5% and 3.3%; AE-related discontinuations: 3.3%, 3.2% and 2.8%), and higher with CANA 100 mg than CANA 300 mg or PBO in subjects ≥65 years (serious AEs: 6.9%, 3.4% and 3.6%; AE-related discontinuations: 8.8%, 5.4% and 4.4%). Subjects ≥65 years on CANA had higher rates than PBO of genital mycotic infections and osmotic diuresis-related AEs. The incidence of AEs related to reduced intravascular volume was low across treatment groups in both age groups. Incidences of urinary tract infections and renal-related AEs were similar across groups in subjects ≥65 years. CANA 100 mg and 300 mg provided reductions in HbA1c and body weight and were generally well tolerated in older subjects with T2DM.Table 1Summary of A1C, Weight, SBP and Selected AEs for Subjects <65 and ≥65 yearsEfficacy Parameters∗,†Subjects <65 ySubjects ≥65 yPBO (n=509)CANA 100 mg (n=674)CANA 300 mg (n=685)PBO (n=137)CANA 100 mg (n=159)CANA 300 mg (n=149)HbA1c change, %–0.15 (0.04)–0.89 (0.03)–1.08 (0.03)–0.05 (0.07)–0.69 (0.07)–0.88 (0.07) Difference vs. PBO–0.74 (0.05)–0.93 (0.05)–0.64 (0.10)–0.82 (0.10)Body weight % change–0.6 (0.2)–2.8 (0.1)–3.4 (0.1)–0.6 (0.3)–2.9 (0.3)–3.8 (0.3) Difference vs. PBO–2.2 (0.2)–2.9 (0.2)–2.3 (0.4)–3.2 (0.4)Systolic BP change, mm Hg–0.3 (0.5)–4.2 (0.4)–4.8 (0.4)–0.8 (1.1)–4.6 (1.0)–5.9 (1.0) Difference vs. PBO–3.9 (0.6)–4.5 (0.6)–3.9 (1.4)–5.1 (1.5)Selected AEs§PBO (n=509)CANA 100 mg (n=674)CANA 300 mg (n=685)PBO (n=137)CANA 100 mg (n=159)CANA 300 mg (n=149)Genital mycotic infection Male|2 (0.8)14 (4.3)11 (3.4)03 (3.7)4 (5.2) Female¶10 (4.1)37 (10.7)44 (12.3)07 (9.0)5 (6.9)Urinary tract infection20 (3.9)41 (6.1)29 (4.2)6 (4.4)8 (5.0)7 (4.7)Osmotic diuresis-related AEs4 (0.8)44 (6.5)39 (5.7)1 (0.7)12 (7.5)8 (5.4)Volume-related AEs5 (1.0)6 (0.9)8 (1.2)2 (1.5)4 (2.5)3 (2.0)Renal-related AEs2 (0.4)2 (0.3)12 (1.8)2 (1.5)3 (1.9)2 (1.3)LS, least squares; SE, standard error; ANCOVA, analysis of covariance.∗ LS mean (SE) change from baseline using ANCOVA and PBO-subtracted LS mean (SE) values.† Data are reported for prior to rescue therapy except for lipid parameters, which are for regardless of rescue therapy.‡ % changes determined based on changes in conventional units.§ Number (%) of subjects.| Males <65 y: PBO, n=263; CANA 100 mg, n=327; CANA 300 mg, n=327; males ≥65 y: PBO, n=71; CANA 100 mg, n=81; CANA 300 mg, n=77.¶ Females <65 y: PBO, n=246; CANA 100 mg, n=347; CANA 300 mg, n=358; females ≥65 y: PBO, n=66; CANA 100 mg, n=78; CANA 300 mg, n=72. Open table in a new tab LS, least squares; SE, standard error; ANCOVA, analysis of covariance. ∗ LS mean (SE) change from baseline using ANCOVA and PBO-subtracted LS mean (SE) values. † Data are reported for prior to rescue therapy except for lipid parameters, which are for regardless of rescue therapy. ‡ % changes determined based on changes in conventional units. § Number (%) of subjects. | Males <65 y: PBO, n=263; CANA 100 mg, n=327; CANA 300 mg, n=327; males ≥65 y: PBO, n=71; CANA 100 mg, n=81; CANA 300 mg, n=77. ¶ Females <65 y: PBO, n=246; CANA 100 mg, n=347; CANA 300 mg, n=358; females ≥65 y: PBO, n=66; CANA 100 mg, n=78; CANA 300 mg, n=72.