Abstract
BackgroundType 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.MethodsPatients 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 <7% and <6.5%.ResultsFrom a mean baseline HbA1c of 8.5% (omarigliptin) and 8.6% (placebo), the least squares (LS) mean change from baseline in HbA1c at Week 24 was −0.67% in the omarigliptin group and −0.06% in the placebo group, with a between-group difference (95% CI) of −0.61% (−0.85, −0.38). Treatment with omarigliptin resulted in a significantly greater reduction in FPG relative to placebo (LS mean difference [95% CI] -0.9 mmol/L [−1.4, −0.4]; p < 0.001). The proportion of patients achieving glycemic goals of <7.0% and <6.5% was higher in the omarigliptin group relative to the placebo group. The overall incidences of adverse events (AEs), serious AEs, drug-related AEs and discontinuations were generally similar between treatment groups. The incidence of symptomatic hypoglycemia was 10.5% in the omarigliptin group and 8.5% in the placebo group. Relative to baseline, omarigliptin and placebo treatments were associated with LS mean changes in body weight of −0.1 kg and −0.9 kg, respectively.ConclusionIn patients with T2D and inadequate glycemic control on dual therapy with metformin and glimepiride, compared with placebo, once-weekly omarigliptin provided greater improvement in glycemic control and was generally well tolerated.Trial registrationClinicalTrials.gov: NCT01704261, EudraCT Number: 2012-002612-10. Trial Registration Date: October 8, 2012.
Highlights
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
Patients were excluded from the study if they had type 1 diabetes, a history of ketoacidosis, active liver disease, new or worsening signs or symptoms of coronary heart disease or congestive heart failure within the past 3 months, a history of malignancy or hematological disorders, or if they had been treated with any antihyperglycemic agent other than the protocol-required metformin and sulfonylurea within 12 weeks prior to signing informed consent
One patient in the omarigliptin group who was discovered to be participating in another study was included in the population of randomized patients for the disposition table but excluded from the efficacy and safety analyses
Summary
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. If additional glycemic control is required, patients can be advanced to triple oral therapy by adding a dipeptidyl peptidase-4 (DPP-4) inhibitor, a class of antihyperglycemic agent which stabilizes incretin peptides (e.g., glucagon-like peptide 1 and glucosedependent insulinotropic peptide), enhancing glucosedependent insulin secretion [3]. We report the results of a clinical study that compared the glycemic efficacy and safety of omarigliptin 25 mg administered q.w. with placebo when added to treatment of patients with inadequate glycemic control on the combination of metformin and glimepiride
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