Most patients with type 2 diabetes (T2D) are treated in primary care, but data to guide evidence-based, shared decision making in this setting are scarce. LIRA-PRIME (NCT02730377) was a randomized, open-label, active-controlled trial in a primary care setting, comparing efficacy and safety of liraglutide vs. an oral antidiabetic drug (OAD) in patients with T2D inadequately controlled with metformin. Patients aged ≥18 years, with A1C 7.5-9.0%, recruited from nine countries (219 sites), were randomized 1:1 using an interactive web response system to liraglutide or an OAD (α-glucosidase inhibitor, DPP-4i, meglitinide, SGLT2i, SU or TZD, chosen by their physician) on top of metformin, for up to 104 weeks. Primary endpoint: time to inadequate glycemic control, defined as A1C >7.0% at two consecutive visits after the first 26 weeks of treatment. Key secondary endpoints: time to premature treatment discontinuation, including for inadequate glycemic control, and occurrence of adverse events (AEs). From Mar 2016 to Aug 2017, patients were randomized to liraglutide (N=996) or OAD (N=995; 48% SGLT2i, 40% DPP-4i, 11% SU). Liraglutide significantly reduced the risk of inadequate glycemic control vs. OAD (416/996 [42%] vs. 547/995 [55%] patients, respectively; hazard ratio [95% CI] 0.58 [0.51;0.66]; p<0.0001) and of premature treatment discontinuation (532/996 [53%] vs. 624/995 [63%], respectively; p<0.0001). Median time to inadequate glycemic control (109 vs. 65 weeks; p<0.0001) and premature treatment discontinuation (80 vs. 52 weeks; p<0.0001) was longer with liraglutide vs. OAD. Rates of serious AEs and hypoglycemic episodes were similar, but more patients discontinued due to gastrointestinal AEs with liraglutide vs. OAD (54/980 [6%] vs. 9/984 [1%], respectively). Within global primary care settings, LIRA-PRIME demonstrated longer lasting glycemic control with liraglutide than with an OAD, when added to metformin.
J. Unger: Consultant; Self; Bayer. Research Support; Self; GlaxoSmithKline, Merck, Pfizer, Sanofi, Lilly, Janssen. Stock/Shareholder; Self; Tandem Diabetes. Other Relationship; Self; Abbott, Abbott Diabetes, Novo Nordisk. M. Kaltoft: Employee; Self; Novo Nordisk A/S. Stock/Shareholder; Self; Novo Nordisk A/S. D. Kolhe: Employee; Self; Novo Nordisk. J. Panda: None. M. Sargın: Speaker’s Bureau; Self; AstraZeneca, Boehringer Ingelheim Pharmaceuticals, Inc., Novo Nordisk Inc., Pfizer Inc. B. Wolthers: Other Relationship; Self; Novo Nordisk. M. Zoghbi: Advisory Panel; Spouse/Partner; Janssen Pharmaceuticals, Inc., New Bridge. Advisory Panel; Self; Novartis AG. Advisory Panel; Spouse/Partner; Novartis AG. Advisory Panel; Self; Novo Nordisk A/S. Advisory Panel; Spouse/Partner; Pfizer Inc., Roche Pharma. Advisory Panel; Self; Sanofi.
Novo Nordisk A/S