A randomized, double-blind, non-inferiority trial evaluating the efficacy and safety of omarigliptin, a once-weekly DPP-4 inhibitor, or glimepiride in patients with type 2 diabetes inadequately controlled on metformin monotherapy

Abstract

After 54 weeks, as add-on therapy to metformin, once-weekly omarigliptin was generally well tolerated and non-inferior to glimepiride in improving glycemic control, with a lower incidence of hypoglycemia and with weight loss vs weight gain.

The efficacy and safety of once-weekly DPP-4 inhibitor omarigliptin in patients with type 2 diabetes mellitus

“…1 . Of 128 records identified by initial electronic search, 11 studies [ 14 – 16 , 20 – 27 ] met our inclusion criteria for the final narrative synthesis with a combined population of 8276 persons with T2DM. No additional study was identified by manual search.…”

“…Only 1 trial [ 14 ] mostly involved patients with renal impairment (estimated glomerular filtration rate <60 mL/min per 1.73 m 2 ). Among 11 trials, 9 trials [ 14 , 15 , 20 – 24 , 26 , 27 ] compared the efficacy and safety of omarigliptin with placebo, 3 trials [ 16 , 20 , 25 ] compared the efficacy and safety of omarigliptin with other AHAs.…”

“…A total of 8 studies [ 14 – 16 , 20 – 22 , 25 , 26 ] explicitly described the random sequence generation, mainly by an interactive voice response system. Eight studies [ 14 – 16 , 20 – 22 , 25 , 26 ] had used unpredicted methods to generate random sequence which stated a low risk of allocation concealment process, whereas 3 studies [ 23 , 24 , 27 ] which lack random sequence generation method were regarded as having an unclear risk of bias in random sequence generation and allocation concealment. All 11 trials [ 14 – 16 , 20 – 27 ] indicated that they had adopted a double-blind design.…”

“…[ 13 ] The less medication frequency may contribute to improved compliance and management of blood glucose level in patients with T2DM. Many studies [ 14 – 16 ] which had tested the efficacy and safety of omarigliptin monotherapy or add on to other AHAs in the treatment of T2DM were published recently. Herein, we conducted a systematic review and meta-analysis to present an overview of the efficacy and safety of omarigliptin in patients with T2DM.…”

Once-weekly oral antidiabetic agent and treatment satisfaction

“…We thank Doctors Takahara et al for their Letter to the Editor in response to our recently published paper in this journal entitled "A randomized, double-blind, non-inferiority trial evaluating the efficacy and safety of omarigliptin, a once-weekly DPP-4 inhibitor, or glimepiride in patients with type 2 diabetes inadequately controlled on metformin monotherapy" 1 . The phase 3 clinical program for omarigliptin demonstrated that it has a safety and efficacy profile similar to that of once-daily DPP-4 inhibitors, but because all subjects received both a once-weekly and a once-daily study drug to maintain blinding, these studies could not assess differences in patient satisfaction between a once-weekly and a oncedaily drug.…”