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Summary   Aims  To assess the safety and efficacy of omarigliptin in subjects with type 2 diabetes mellitus (T2 DM ) and chronic renal impairment ( RI ).    Methods  Patients with T2 DM  with moderate  RI  (estimated glomerular filtration rate [ eGFR ] ≥30 to &lt;60  mL /min/1.73 m 2 ) (N=114), severe  RI  ( eGFR  &lt;30  mL /min/1.73 m 2 ) (N=55) or end‐stage renal disease on dialysis (N=44), who were either not on an antihyperglycaemic agent therapy for at least 12 weeks at screening, washed‐off of oral antihyperglycaemic agent monotherapy or low‐dose dual combination therapy, or on insulin monotherapy, with baseline glycated haemoglobin (HbA1c) of 6.5%‐10.0% were randomised to omarigliptin or to placebo for 24 weeks (primary end‐point) followed by a 30‐week period with subjects on placebo switched to blinded glipizide (if not on insulin).    Results  After 24 weeks, from a mean baseline HbA1c of 8.4% in the omarigliptin group and 8.3% in the placebo group, the least squares mean (95%  CI ) change from baseline in HbA1c in the overall population (all renal strata combined) was −0.77% (−1.00 to −0.54) in the omarigliptin group and −0.44% (−0.67 to −0.21) in the placebo group; between‐group difference of −0.33% (−0.63 to −0.02);  P =0.035. After 24 weeks, the incidences of subjects with symptomatic hypoglycaemia, one or more adverse event ( AE ), drug‐related  AE , serious  AE  and discontinuation due to an  AE  were similar in the omarigliptin and placebo groups.    Conclusions  In this study in subjects with T2 DM  and  RI , relative to placebo, omarigliptin provided clinically meaningful reductions in HbA1c, had a similar incidence of symptomatic hypoglycaemia and was generally well tolerated.

international journal of clinical practice

A randomised, double‐blind, trial of the safety and efficacy of omarigliptin (a once‐weekly  DPP ‐4 inhibitor) in subjects with type 2 diabetes and renal impairment