Safiglipron lowered HbA1c in a type 2 diabetes trial
The OUTSTAND-1 phase 3 trial in China enrolled 284 adults managing type 2 diabetes with diet and exercise alone. HbA1c fell more after 32 weeks in each oral safiglipron dose group than with placebo. Effects on weight were smaller, while gastrointestinal adverse events occurred. The findings apply to this patient group and follow-up period; the trial did not establish that the drug is superior to other diabetes treatments.
Science··Midday
The OUTSTAND-1 comparison
OUTSTAND-1 tested once-daily oral safiglipron in 284 adults at 46 sites in China. Participants had type 2 diabetes managed with diet and exercise, without glucose-lowering medication at enrollment. Three groups received 30, 60 or 90 milligrams, while a fourth received placebo. Nature Medicine published the randomized, double-blind trial, and BioTrade reported the same drug, population and 32-week comparison. This is a direct placebo test in a defined early-disease setting; it is not a head-to-head test against other diabetes medicines.[1], [2]
Blood sugar and body weight
The primary measure was change in HbA1c, an indicator of average blood glucose over preceding months. Compared with placebo, the three dose groups had additional falls of 1.22, 1.20 and 1.45 percentage points by week 32, respectively. More participants taking safiglipron reached the trial’s HbA1c targets, and fasting blood glucose was also lower than in the placebo group. Weight differences were smaller and varied by dose. The similar size of the HbA1c changes does not establish that the highest dose is best for every outcome.[1]
Safety and applicability
Gastrointestinal adverse events were the most frequent and were mostly described as mild or moderate. Treatment discontinuation attributed to adverse events occurred in the active groups and was most frequent at 90 milligrams. The blinded placebo comparison strengthens the finding on short-term blood sugar control, but it does not establish effects on heart disease, kidney outcomes or survival. All participants were recruited in China, and the enrollment criteria selected people using diet and exercise alone. Studies in other populations and against existing drugs are separate questions.[1]
