In the U.S., ~45% of patients with T2D are ≥65 years old, of whom ~50% have mild renal insufficiency (eGFR ≥60 and <90 mL/min/1.73 m2). Older people may respond to AHA treatment differently from younger people, and assessments focused on the older population are desirable. We conducted a post hoc analysis of the cohort of patients ≥65 years who participated in a 24-week randomized, double-blind clinical trial (NCT02532855) of the efficacy and safety of SITA 100 mg qd vs. DAPA 10 mg qd in people with mild renal insufficiency while on MET ± SU; the primary efficacy endpoint was change in A1C at Week 24, analyzed with an LDA model.

Treatment groups were well-balanced at baseline (mean A1C [%] = 7.7/7.7, mean eGFR [mL/min/1.73 m2] = 79/76 for SITA/DAPA). At Week 24, LS mean reduction from baseline A1C was greater with SITA compared with DAPA (Table). With SITA treatment, 41% of participants were at A1C goal of <7.0% compared to 28% with DAPA (Table). The SITA group had greater reductions in post-prandial glucose endpoints, and the DAPA group had greater reductions in FPG (Table). Treatments were generally well tolerated; there were significantly fewer drug-related AEs with SITA than with DAPA, but AE profiles were otherwise similar.

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Disclosure

A. Raji: Employee; Self; Merck & Co., Inc. Stock/Shareholder; Self; Merck & Co., Inc. Z. Xu: Employee; Self; Merck & Co., Inc. Stock/Shareholder; Self; Merck & Co., Inc. R.L. Lam: Employee; Self; Merck & Co., Inc. K.D. Kaufman: Employee; Self; Merck & Co., Inc. Stock/Shareholder; Self; Merck & Co., Inc. S.S. Engel: Employee; Self; Merck & Co., Inc. Stock/Shareholder; Self; Merck & Co., Inc.

Funding

Merck & Co., Inc.

© 2019 by the American Diabetes Association.
2019
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