Maintenance of Glycemic Control with Liraglutide versus Oral Antidiabetic Drugs as Add-on Therapies in Patients with Type 2 Diabetes Uncontrolled with Metformin Alone: A Randomized Clinical Trial in Primary Care (LIRA-PRIME).

AIMS LIRA-PRIME (NCT02730377), a randomized open-label trial, compared efficacy of liraglutide in controlling glycemia versus an oral antidiabetic drug (OAD) in patients with uncontrolled type 2 diabetes (T2D) despite metformin use in a primary care setting (n=219 sites, n=9 countries). MATERIALS AND METHODS Adults (n=1991) with T2D (glycated hemoglobin [HbA1c ] 7.5-9.0%) receiving metformin were randomized 1:1 to liraglutide (≤1.8 mg/day) or one OAD, selected by the investigator, added to metformin, for up to 104 weeks. Primary endpoint: time to inadequate glycemic control (HbA1c >7.0%) at two scheduled consecutive visits after Week 26. Outcomes were assessed for liraglutide versus a pooled OAD group, and (post hoc) liraglutide versus sodium-glucose cotransporter-2 inhibitors, dipeptidyl peptidase-4 inhibitors and sulfonylureas individually. RESULTS Among randomized patients (liraglutide, n=996; OAD, n=995), 47.6% were female, mean age was 57.4 years and mean HbA1c was 8.2%. Median time to inadequate glycemic control was 44 weeks longer with liraglutide versus OAD (109 weeks [25% percentile, 38; 75% percentile, not available] versus 65 weeks [25% percentile, 35; 75% percentile, 107], P<0.0001). Changes in HbA1c and body weight at Week 104/premature treatment discontinuation significantly favored liraglutide over OAD. Hypoglycemia rates were comparable between groups and few patients discontinued due to adverse events (liraglutide, 7.9% [n=79]; OAD, 4.1% [n=41]). Similar results were observed in the post hoc analysis for liraglutide versus individual OAD classes. CONCLUSIONS Glycemic control was better maintained with liraglutide versus OAD, supporting liraglutide use when intensifying therapy in primary care patients with T2D. This article is protected by copyright. All rights reserved.