Weekly dulaglutide matches daily liraglutide for A1C in type 2 diabetes trial
The trial found a once-weekly GLP-1 injection was non-inferior to a once-daily one for A1C, a practical difference for people with type 2 diabetes who take these medicines.
A phase 3 trial called AWARD-6 found that once-weekly dulaglutide 1.5 mg was non-inferior to once-daily liraglutide 1.8 mg for lowering A1C in people with type 2 diabetes who were already taking metformin [1]. The study enrolled 599 patients at 62 sites in nine countries and ran from June 20, 2012, to Nov 25, 2013 [1].
Participants were adults aged 18 or older with A1C between 7.0% and 10.0% and a body-mass index of 45 kg/m² or lower [1]. All were taking metformin at a dose of at least 1,500 mg per day [1]. They were randomly assigned to dulaglutide once weekly (299 patients) or liraglutide once daily (300 patients) [1]. The trial was open-label, so participants and investigators knew which treatment each person received [1].
The main question was whether dulaglutide was non-inferior to liraglutide for change in A1C at 26 weeks, using a margin of 0.4 percentage points [1]. The least-squares mean A1C reduction was 1.42 percentage points (SE 0.05) with dulaglutide and 1.36 percentage points (SE 0.05) with liraglutide [1]. The mean treatment difference was -0.06 percentage points (95% CI -0.19 to 0.07; p non-inferiority <0.0001) [1]. In each group, 269 participants completed treatment at week 26 [1].
Safety results were similar between the two groups [1]. The most common gastrointestinal adverse events were nausea (20% with dulaglutide vs 18% with liraglutide), diarrhea (12% vs 12%), dyspepsia (8% vs 6%), and vomiting (7% vs 8%) [1]. Discontinuation of the study or study drug because of adverse events occurred in 6% of each group [1]. Hypoglycemia rates were 0.34 events per patient per year with dulaglutide and 0.52 with liraglutide, and no severe hypoglycemia was reported [1].
The authors concluded that once-weekly dulaglutide was non-inferior to once-daily liraglutide for A1C reduction, with a similar safety and tolerability profile [1]. The trial was funded by Eli Lilly and Company [1]. An erratum was published in The Lancet on Oct 11, 2014 [1].
Why it matters for patients
For people with type 2 diabetes, the choice between a once-weekly injection and a once-daily injection can affect daily routines. In this trial, the once-weekly option did not show worse A1C lowering than the once-daily option, and the two drugs had similar rates of side effects and discontinuations [1]. That is the main practical finding: dosing frequency was the clear difference tested, while glycemic control and tolerability were close [1].
The results apply to the group studied: adults with type 2 diabetes taking metformin who had A1C between 7.0% and 10.0% [1]. They may not apply to people with different A1C levels, those not taking metformin, or those using other diabetes medicines [1]. The trial was open-label, meaning participants knew which drug they were getting, which can influence how side effects are reported [1]. The study was funded by Eli Lilly and Company [1].
Both drugs are GLP-1 receptor agonists, a class that can cause gastrointestinal side effects [1]. In this trial, nausea was the most common, affecting about one in five participants in each group [1]. No severe hypoglycemia was reported, but hypoglycemia events did occur at low rates in both groups [1].
Sources
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