Open AccessA 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
Author(s) -
Chacra Antonio,
Gantz Ira,
Mendizabal Geraldine,
Durlach Lucila,
O'Neill Edward A.,
Zimmer Zachary,
Suryawanshi Shailaja,
Engel Samuel S.,
Lai Eseng
Publication year - 2017
Publication title -
international journal of clinical practice
Language(s) - English
Resource type - Journals
SCImago Journal Rank - 0.756
H-Index - 98
eISSN - 1742-1241
pISSN - 1368-5031
DOI - 10.1111/ijcp.12955
Subject(s) - medicine , placebo , discontinuation , renal function , adverse effect , diabetes mellitus , population , type 2 diabetes , glipizide , clinical endpoint , kidney disease , randomized controlled trial , gastroenterology , surgery , insulin , endocrinology , alternative medicine , environmental health , pathology
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 <60 mL /min/1.73 m 2 ) (N=114), severe RI ( eGFR <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.