Trelagliptin once-weekly safe, effective for T2DM with severe renal impairment
A once-weekly regimen of 25 mg trelagliptin is effective and safe for type 2 diabetes mellitus (T2DM) patients with severe renal impairment or end-stage renal disease (ESRD), reports a new study.
Researchers conducted a multicentre, randomized, phase III study including T2DM patients who received either trelagliptin (n=55; mean age, 65.8±10.28 years; 69.1 percent male) or placebo (n=52; mean age, 65.8±10.46 years; 75.0 percent male) for the first 12 weeks. This was followed by a 40-week open-label phase where both groups were given trelagliptin. Eligible participants had renal impairment or ESRD.
At the end of the 12-week double-blind phase, the reduction in glycated haemoglobin (HbA1c) was significantly greater in the trelagliptin vs placebo group (least square [LS] mean difference, –0.72 percent, 95 percent CI, –0.966 to –0.473; p<0.0001).
Similarly, the proportion of patients with HbA1c <7.0 percent was significantly higher in the trelagliptin group (50.0 percent vs 17.1 percent; difference, 32.9 percent, 14.194–51.660). Similar improvements were reported for fasting blood glucose, glycoalbumin and fasting glucagon after the first 12 weeks.
Notably, after the placebo group started receiving trelagliptin during the open-label phase, mean HbA1c level dropped to a level similar to that in the original trelagliptin group.
In terms of safety, there were nominally more treatment-emergent adverse events (TEAE) in the trelagliptin vs placebo group during the double-blind phase (72.7 percent vs 61.5 percent). Five patients had to discontinue therapy due to severe TEAEs, four of whom belonged to the trelagliptin group.
During the open-label phase, the incidence rates of TEAEs in the trelagliptin and placebo groups were 98.2 percent and 100.0 percent. No deaths or serious drug-related TEAEs were reported.