A randomized, placebo-controlled clinical trial evaluating the safety and efficacy of the once-weekly DPP-4 inhibitor omarigliptin in patients with type 2 diabetes mellitus inadequately controlled by glimepiride and metformin

• Published in: BMC endocrine disorders 2017-11, Vol.17 (1), p.70-9, Article 70
• Main Authors: Lee, Seung-Hwan, Gantz, Ira, Round, Elizabeth, Latham, Melanie, O'Neill, Edward A, Ceesay, Paulette, Suryawanshi, Shailaja, Kaufman, Keith D, Engel, Samuel S, Lai, Eseng
• Format: Article
• Language: English
• Subjects: Aged; Care and treatment; Clinical trials; Complications and side effects; Development and progression; Diabetes Mellitus, Type 2 - drug therapy; Dipeptidyl-Peptidase IV Inhibitors - administration & dosage; Dipeptidyl-Peptidase IV Inhibitors - adverse effects; Dosage and administration; Drug therapy; Drug Therapy, Combination; Female; Glimepiride; Heterocyclic Compounds, 2-Ring - administration & dosage; Heterocyclic Compounds, 2-Ring - adverse effects; Humans; Hypoglycemic Agents - administration & dosage; Incretin therapy; Male; Metformin; Metformin - administration & dosage; Middle Aged; MK-3102; Oral antihyperglycemic agent; Pyrans - administration & dosage; Pyrans - adverse effects; Sulfonylurea Compounds - administration & dosage; Type 2 diabetes
• ISSN: 1472-6823; 1472-6823
• DOI: 10.1186/s12902-017-0219-x

Type 2 diabetes (T2D) is a progressive disease that often requires a patient to use multiple antihyperglycemic agents to achieve glycemic control with disease progression. Omarigliptin is a once-weekly dipeptidyl peptidase-4 inhibitor. The purpose of this trial was to assess the efficacy and safety of adding omarigliptin to the treatment regimen of patients with T2D inadequately controlled by dual therapy with metformin and glimepiride. Patients with T2D and HbA1c ≥7.5% and ≤10.5% while on metformin (≥1500 mg/day) and glimepiride (≥4 mg/day) were randomized to omarigliptin 25 mg once-weekly (N = 154) or placebo (N = 153) for 24 weeks. The primary objective was to assess whether omarigliptin was superior to placebo in reducing HbA1c at Week 24. Secondary objectives were to assess the effects of omarigliptin vs. placebo on FPG and the proportion of subjects attaining HbA1c goals of