A Phase 2, Randomized, Dose-Finding Study of the Novel Once-Weekly @entity1 GLP-1 Analog, Semaglutide, Compared With Placebo and Open-Label Liraglutide in XXXX With Type 2 Diabetes.

@entity1 @entity4051 @entity390 @entity69217 @entity6 @entity391 @entity344 @entity4053 @entity164 @entity8142
OBJECTIVE: To investigate the dose-response relationship of semaglutide versus placebo and open-label liraglutide in terms of glycemic control in @entity1 with @entity164 2 @entity6 . RESEARCH DESIGN AND METHODS: This was a 12-week, randomized, double-blind phase 2 trial. @entity1 (n = 415) were randomized to receive a subcutaneous injection of @entity69217 once weekly without dose escalation (0.1-0.8 mg) or with dose escalation (E) (0.4 mg steps to 0.8 or 1.6 mg E over 1-2 weeks), open-label liraglutide once daily (1.2 or 1.8 mg), or placebo. The primary end point was change in HbA1c level from baseline. Secondary end points included change in body weight, safety, and tolerability. RESULTS: @entity69217 dose-dependently reduced the level of @entity4051 c from baseline (8.1    0.8%) to week 12 by up to -1.7%, and body weight by up to -4.8 kg (1.6 mg E, P < 0.001 vs. placebo). Up to 81% of @entity1 achieved an @entity4051 c level of <7%. @entity4051 c level and weight reductions with semaglutide 1.6 mg E were greater than those with liraglutide 1.2 and 1.8 mg (based on unadjusted CIs), but adverse events (AEs) and withdrawals occurred more frequently. The incidence of @entity390 , @entity391 , and withdrawal due to @entity344 increased with the semaglutide dose; most events were mild to moderate, transient, and ameliorated by dose escalation. There were no major episodes of @entity4053 and few cases of injection site reactions. CONCLUSIONS: After 12 weeks, semaglutide dose-dependently reduced @entity4051 c level and weight in @entity1 with @entity164 2 @entity6 . No unexpected safety or tolerability concerns were identified; @entity344 typical of @entity8142 agonists were mitigated by dose escalation. On this basis, weekly semaglutide doses of 0.5 and 1.0 mg with a 4-week dose escalation were selected for phase 3.
