Anagliptin and sitagliptin as add‐ons to metformin for patients with type 2 diabetes: a 24‐week, multicentre, randomized, double‐blind, active‐controlled, phase III clinical trial with a 28‐week extension

Abstract

We conducted a 24-week, multicentre, double-blind, randomized study with a 28-week extension to compare the efficacy and safety of anagliptin and sitagliptin as an add-on to metformin in patients with type 2 diabetes. Patients inadequately controlled on metformin were randomized to either anagliptin (100 mg twice daily, n = 92) or sitagliptin (100 mg once daily, n = 88). The primary endpoint was the change in glycated haemoglobin (HbA1c) from baseline to week 24. The mean changes in HbA1c were -0.85 ± 0.70% (p < 0.0001) for anagliptin and -0.83 ± 0.61% (p < 0.0001) for sitagliptin, with a mean difference of -0.02% (95% confidence interval of difference, -0.22 to 0.18%). In both groups, the fasting proinsulin : insulin ratio significantly decreased from baseline, with improved insulin secretion. Safety profiles were similar in each group. In conclusion, the non-inferiority of the efficacy of anagliptin to sitagliptin as an add-on therapy was established with regard to efficacy and safety.

Randomized, Double‐Blinded, Double‐Dummy, Active‐Controlled, and Multiple‐Dose Clinical Study Comparing the Efficacy and Safety of Mulberry Twig (Ramulus Mori, Sangzhi) Alkaloid Tablet and Acarbose in Individuals with Type 2 Diabetes Mellitus

“…Thus, the estimate of sample size was based on the feasibility of conducting a clinical trial. Albeit similar to other proof-of-concept studies [ 5 , 38 ], our sample size was smaller than some later stage studies [ 39 ]. Despite this, every patient was strictly matched for features of type 2 diabetes and inclusion criteria in our study.…”

Combination Therapy of Oral Hypoglycemic Agents in Patients with Type 2 Diabetes Mellitus

“…In trials with oral combination therapy, HbA1c decreased by 0.66% in the non-Asian dominant studies, whereas it decreased by 0.85% in the Asian-dominant studies. In fact, in clinical studies conducted in Korea, the HbA1c-lowering effect of DPP4i was 0.8% to 1.2% after 24 weeks of treatment with around 8% of baseline HbA1c [ 32 33 34 ]. These results are comparable to the efficacy of the SGLT2i [ 20 ].…”

Teneligliptin versus sitagliptin in Korean patients with type 2 diabetes inadequately controlled with metformin and glimepiride: A randomized, double‐blind, non‐inferiority trial

“…Although international and local guidelines all recommend lifestyle management as the mainstay of treatment for T2DM, with metformin as the preferred initial oral antihyperglycaemic agent in most patients, there remains no consensus regarding which classes of agent(s) to add as dual and triple therapy, if and when required. 2-5 DPP-4 inhibitors are an important option in these cases, but few phase 3 studies have directly compared DPP-4 inhibitors as add-on therapy [19][20][21][22]. This may be a particularly important exercise in Asian patients, because this population is characterized by less obesity and greater susceptibility to β-cell dysfunction than Western populations,23,24 as well as differences in dietary behaviour that may warrant separate assessment of the efficacy of individual drugs.Reductions in mean HbA1c in the present study (teneligliptin, −1.03%; sitagliptin, −1.02%) were somewhat higher than those described in a recent meta-analysis assessing the impact of adding a DPP-4 inhibitor to dual therapy with metformin and a sulfonylurea (mean change in HbA1c: −0.71% [95% CI: −0.79, −0.63])…”