Omarigliptin, an investigational once-weekly DPP-4 inhibitor in development for adults with type 2 diabetes, has achieved its primary efficacy endpoint in a phase 3 study. Omarigliptin was found to be non-inferior to once-daily DPP-4 inhibitor, Sitagliptin ( Januvia (, at reducing patients’ A1C levels from baseline, with similar A1C reductions achieved in both groups.
The head-to-head study was designed to evaluate once-weekly treatment with Omarigliptin 25 mg compared to 100 mg of Sitagliptin once daily.
Results were presented at the 51st European Association for the Study of Diabetes ( EASD ) Annual Meeting.
The phase 3 randomized, double-blind, non-inferiority trial assessed the efficacy, safety and tolerability of Omarigliptin 25 mg once weekly compared to Sitagliptin 100 mg once daily in adults with type 2 diabetes ( n=642 ) who experienced inadequate glycemic control while taking Metformin.
The primary efficacy endpoint was non-inferiority of Omarigliptin to Sitagliptin in decreasing A1C levels from baseline to week 24.
At the start of the trial, baseline A1C was approximately 7.5% in both groups. Mean baseline fasting plasma glucose ( FPG ) levels were also similar between treatment groups.
The study achieved its primary efficacy endpoint of non-inferior reductions in A1C for Omarigliptin compared to Sitagliptin at 24 weeks.
At week 24, patients taking Omarigliptin had an average A1C reduction from baseline of -0.47% as compared to an average reduction of -0.43% among patients taking Sitagliptin, with a difference of -0.03 between groups ( 95% CI [ -0.15, 0.08 ] ).
In patients in the pre-specified sub-group with a higher baseline A1C of greater than or equal to 8.0%, Omarigliptin treatment resulted in reductions of -0.79% compared to -0.71% for Sitagliptin ( difference = -0.08%; 95% CI [ -0.37, 0.21 ] ).
The percentage of patients achieving their A1C goals was similar for both Omarigliptin and Sitagliptin. At 24 weeks, 51% of patients treated with Omarigliptin reached an A1C of less than 7.0%, compared to 49% of patients treated with Sitagliptin ( p=0.334 ).
The percentage of patients reaching an A1C of less than 6.5% was also similar across treatment groups: 27% for Omarigliptin compared with 23% for Sitagliptin ( p=0.219 ).
FPG was reduced from baseline by 0.8 mmol/L in the Omarigliptin group and 0.5 mmol/L in the Sitagliptin group, with a between-group difference of -0.2 mmol/L ( p= 0.089 ).
The incidences of serious adverse events, drug-related adverse events and discontinuations were similar across both treatment groups. Common adverse events included diarrhea ( 0.9% for Omarigliptin versus 2.8% for Sitagliptin ), influenza ( 0.3% vs. 2.2% ), upper respiratory tract infection ( 4.0% vs. 3.8% ), urinary tract infection ( 1.2% vs. 2.8% ), lipase increase ( 2.5% vs. 4.1% ) and back pain ( 2.5% vs. 0.6% ).
Adverse events of hypoglycemia ( symptomatic and asymptomatic ) were reported in 3.7% of the Omarigliptin group ( with one severe hypoglycemia event reported ) and 4.7% of the Sitagliptin group. ( Xagena )
Source: Merck, 2015