Trial demonstrates improved glycaemic control in patients with type 2 diabetes
The addition of once-daily cetagliptin to metformin has proven to be a more efficacious and well-tolerated approach compared to metformin monotherapy in Chinese patients with type 2 diabetes experiencing inadequate glycaemic control with metformin alone, according to a study.
The trial, including 446 patients with type 2 diabetes, employed a randomization process to administer once-daily doses of cetagliptin at both 100 mg and 50 mg, as well as a placebo, in a ratio of 2:2:1 over a 24-week double-blind treatment period. At the conclusion of this phase, patients initially receiving cetagliptin 50 mg and the placebo were transitioned to cetagliptin 100 mg for an additional 28 weeks of open-label treatment.
Both cetagliptin add-on therapies demonstrated superior glycaemic control. Reductions in haemoglobin A1c (HbA1c) levels from baseline were recorded at -1.17 ± 0.794% for the cetagliptin 100 mg group and -1.23 ± 0.896% for the cetagliptin 50 mg group, when combined with metformin. No significant disparity was observed between the 2 cetagliptin dosage groups.
Patients with higher baseline HbA1c levels (≥8.5%) experienced even more pronounced reductions in HbA1c. A substantially greater proportion of patients achieved the desired HbA1c level of <7.0% when supplemented with cetagliptin—49.4% for the 100 mg group and 51.1% for the 50 mg group—compared to those on metformin monotherapy (14.4%).
Both combination therapies exhibited improvements in the homeostasis model assessment β-function index and a decrease in systolic blood pressure. There was no indication of an elevated risk of adverse effects associated with combination therapy.
Ji L, Lu J, Gao L, et al. A randomized, double-blind, placebo controlled, phase 3 trial to evaluate the efficacy and safety of cetagliptin added to ongoing metformin therapy in patients with uncontrolled type 2 diabetes with metformin monotherapy. Diabetes Obes Metab. 2023;doi: 10.1111/dom.15274. Epub ahead of print. PMID: 37724698.