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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

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

Antonio Chacra, Ira Gantz, Geraldine Mendizabal, Lucila Durlach, Edward A O'Neill, Zachary Zimmer, Shailaja Suryawanshi, Samuel S Engel, Eseng Lai

Int J Clin Pract. 2017 Jun;71(6):e12955.

PMID: 28449320

Abstract:

Aims:
To assess the safety and efficacy of omarigliptin in subjects with type 2 diabetes mellitus (T2DM) and chronic renal impairment (RI).
Methods:
Patients with T2DM with moderate RI (estimated glomerular filtration rate [eGFR] ≥30 to <60 mL/min/1.73 m2 ) (N=114), severe RI (eGFR <30 mL/min/1.73 m2 ) (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 T2DM and RI, relative to placebo, omarigliptin provided clinically meaningful reductions in HbA1c, had a similar incidence of symptomatic hypoglycaemia and was generally well tolerated.

Chemicals Related in the Paper:

Catalog Number	Product Name	Structure	CAS Number	Price
CS310361	Glipizide Related Compound C			Price

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