LIRA-PRIME Trial Design and Baseline Data—Efficacy in Controlling Glycemia with Liraglutide in a Primary Care Setting

Despite the majority of patients with type 2 diabetes (T2D) being treated in primary care, clinical evidence to guide treatment decisions is still scarce in this setting. LIRA-PRIME (NCT02730377), a 104-week, randomized (1:1), open-label, active-controlled trial in primary care, compares the efficacy of liraglutide vs. oral antidiabetic drugs (chosen by the investigator) in controlling glycemia in patients with T2D inadequately controlled with metformin alone. Besides an A1C of 7.5-9.0% within 90 days prior to screening, the pragmatic approach of the trial includes few inclusion and exclusion criteria, treatment according to local labels, quarterly visits after week 26, and trial product dispensing by retail pharmacy. Primary endpoint is time to inadequate glycemic control, defined as A1C >7.0% at two scheduled consecutive visits after the first 26 weeks of treatment. The trial randomized 1997 patients from 9 countries. The broad distribution of baseline characteristics, e.g., age range of 19.0-89.0 years, reflects the study design and heterogeneity of patients treated in primary care (Table). LIRA-PRIME will provide data-currently lacking-from primary care regarding the efficacy of liraglutide in controlling glycemia in patients with T2D inadequately controlled with metformin alone. A population with such broad baseline characteristics is well suited for this investigation. Disclosure J. Unger: Advisory Panel; Self; Novo Nordisk A/S, Abbott. Consultant; Self; Novo Nordisk A/S, Abbott. Research Support; Self; Novo Nordisk A/S, Janssen Pharmaceuticals, Inc., Sanofi-Aventis, Merck & Co., Inc., Abbott, Mylan. Speaker9s Bureau; Self; Novo Nordisk A/S, Janssen Pharmaceuticals, Inc.. Stock/Shareholder; Self; Novo Nordisk A/S. D. Lowe: Consultant; Self; Novo Nordisk A/S. G. Murphy: None. J. Panda: Advisory Panel; Self; AstraZeneca, Boehringer Ingelheim GmbH, Sanofi, Eli Lilly Ltd.. Employee; Self; Department of Health & Family Welfare, Govt. of Odisha, India. Research Support; Self; Novo Nordisk India Ltd. M. Sargin: Speaker9s Bureau; Self; Novo Nordisk A/S, AstraZeneca. M. Kaltoft: Employee; Self; Novo Nordisk A/S. M. Treppendahl: Employee; Self; Novo Nordisk A/S. Stock/Shareholder; Self; Novo Nordisk A/S. M. Zoghbi: Advisory Panel; Self; Novo Nordisk A/S. Research Support; Self; Pharmaline. Speaker9s Bureau; Self; Eli Lilly and Company, Merck Sharp & Dohme Corp., Novartis AG, AstraZeneca, Novo Nordisk A/S. Advisory Panel; Spouse/Partner; AbbVie Inc., NewBridge.