Clinical development
Clinical study background
Alogliptin (Nesina®) is a new drug for the treatment of adult patients with type 2 diabetes (T2D) by inhibiting the dipeptidyl peptidase-4 (DPP-4) enzyme and thereby prevent degradation of incretin hormones [1]. There were a number of clinical evidences for this DPP-4 inhibitor drug to define its use in treating T2D, including the clinical phase I, clinical phase II and III studies, but this review only detailed descripted some typical clinical studies to demonstrate the efficacy and safety of this product. The oral alogliptin can work as monotherapy or in combination with other oral antihyperglycaemic agents in the treatment. The clinical subjects in these studies receiving alogliptin once a day, and all the studies are randomized, double-blind and placebo-controlled studies, which following Good Clinical Practice and ethical standards for studies in humans.
Evidence for clinical effectiveness
Clinical phase I study …show more content…
The subjects in this study are thirty-six healthy, nonobese males from 18 years old to 55 years old (29/36 [81%] white; mean age, 26.6 years; mean weight, 76.0 kg) [2]. This thirty-six subjects were assigned into six cohorts in an ascending-dose strategy, they received the oral alogliptin once a day in 25, 50, 100, 200 and 800 mg, respectively. Every cohort has one subject received placebo, and each cohort start their assigned dose after the confirmation of the safety data from the previous cohort. The tolerability was evaluated based on the adverse events and clinical assessments, while efficacy endpoints include plasma DPP-4 inhibition and active glucagon-like peptide (GLP-1) concentrations, which were collected from blood and urine of the subjects over 72 hours after
Clinical study background
Alogliptin (Nesina®) is a new drug for the treatment of adult patients with type 2 diabetes (T2D) by inhibiting the dipeptidyl peptidase-4 (DPP-4) enzyme and thereby prevent degradation of incretin hormones [1]. There were a number of clinical evidences for this DPP-4 inhibitor drug to define its use in treating T2D, including the clinical phase I, clinical phase II and III studies, but this review only detailed descripted some typical clinical studies to demonstrate the efficacy and safety of this product. The oral alogliptin can work as monotherapy or in combination with other oral antihyperglycaemic agents in the treatment. The clinical subjects in these studies receiving alogliptin once a day, and all the studies are randomized, double-blind and placebo-controlled studies, which following Good Clinical Practice and ethical standards for studies in humans.
Evidence for clinical effectiveness
Clinical phase I study …show more content…
The subjects in this study are thirty-six healthy, nonobese males from 18 years old to 55 years old (29/36 [81%] white; mean age, 26.6 years; mean weight, 76.0 kg) [2]. This thirty-six subjects were assigned into six cohorts in an ascending-dose strategy, they received the oral alogliptin once a day in 25, 50, 100, 200 and 800 mg, respectively. Every cohort has one subject received placebo, and each cohort start their assigned dose after the confirmation of the safety data from the previous cohort. The tolerability was evaluated based on the adverse events and clinical assessments, while efficacy endpoints include plasma DPP-4 inhibition and active glucagon-like peptide (GLP-1) concentrations, which were collected from blood and urine of the subjects over 72 hours after