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DPP4 inhibitor cetagliptin effective and well-tolerated for treating patients with type 2 diabetes
China: A randomized double-blind, placebo-controlled phase 3 trial has shed light on the safety and efficacy of cetagliptin as monotherapy in patients with type 2 diabetes (T2D) with inadequate glycemic control on diet and exercise.
The study, published in Diabetes, Obesity and Metabolism, showed cetagliptin monotherapy to be well-tolerated and effective in Chinese patients with T2D with inadequate glycemic control on diet and exercise. The researchers, thus, suggest that cetagliptin may serve as a valuable addition to the option of medications available for T2D management.
Favourable attributes such as a low hypoglycemia incidence, minimal impact on weight gain, and no significant differences in rates of CVD (cardiovascular disease) outcomes, underline the utility of dipeptidyl peptidase-4 (DPP-4) inhibitors for type 2 diabetes treatment. Linong Ji, Peking University People's Hospital, Beijing, China, and colleagues aimed to assess the safety and efficacy of the DPP-4 inhibitor, cetagliptin, as monotherapy in Chinese patients with type 2 diabetes and inadequate glycaemic control.
A total of 504 eligible patients with type 2 diabetes were enrolled in the study. They were randomized in the ratio of 2:2:1 to receive cetagliptin 50 mg once daily, cetagliptin 100 mg once daily or placebo for 24 weeks of double-blind treatment. Then, all patients received once-daily cetagliptin 100 mg for 28 weeks of open-label treatment. The primary efficacy endpoint of the study was determined as the change in HbA1c level from baseline at week 24.
The study led to the following findings:
- After 24 weeks, HbA1c from baseline was significantly reduced with cetagliptin 50 mg (−1.08%) and cetagliptin 100 mg (−1.07%) compared with placebo (−0.35%).
- The placebo-subtracted HbA1c reduction was −0.72% with cetagliptin 50 mg and 100 mg.
- Patients with a baseline HbA1c of 8.5% or higher had a greater HbA1c reduction with cetagliptin than those patients with a baseline HbA1c of less than 8.5%.
- Both doses studied led to a significantly higher proportion of patients (42.3% with 100 mg and 45.0% with 50 mg) achieving an HbA1c of less than 7.0% compared with placebo (12.9%).
- Cetagliptin also significantly lowered fasting plasma glucose and 2-hour postmeal plasma glucose relative to placebo.
- The incidence of adverse experiences was similar between cetagliptin and placebo. No drug-related hypoglycaemia was reported.
"Cetagliptin monotherapy was well tolerated and effective and well tolerated in Chinese patients with T2D who had inadequate glycaemic control on exercise and diet," the researchers wrote.
"Cetaglipitin, as demonstrated in this trial, may thus serve as a valuable addition to the option of medications available for type 2 diabetes management," they concluded.
Reference:
Efficacy and safety of cetagliptin as monotherapy in patients with type 2 diabetes: A randomized, double-blind, placebo-controlled phase 3 trial. Diabetes Obes Metab 2023 Sep 03;[EPub Ahead of Print], L Ji, J Lu, L Gao, C Ying, J Sun, J Han, W Zhao, Y Gao, K Wang, X Zheng, D Xie, J Ding, J Zhao, Q Yu, T Wang
MSc. Biotechnology
Medha Baranwal joined Medical Dialogues as an Editor in 2018 for Speciality Medical Dialogues. She covers several medical specialties including Cardiac Sciences, Dentistry, Diabetes and Endo, Diagnostics, ENT, Gastroenterology, Neurosciences, and Radiology. She has completed her Bachelors in Biomedical Sciences from DU and then pursued Masters in Biotechnology from Amity University. She has a working experience of 5 years in the field of medical research writing, scientific writing, content writing, and content management. She can be contacted at  editorial@medicaldialogues.in. Contact no. 011-43720751
Dr Kamal Kant Kohli-MBBS, DTCD- a chest specialist with more than 30 years of practice and a flair for writing clinical articles, Dr Kamal Kant Kohli joined Medical Dialogues as a Chief Editor of Medical News. Besides writing articles, as an editor, he proofreads and verifies all the medical content published on Medical Dialogues including those coming from journals, studies,medical conferences,guidelines etc. Email: editorial@medicaldialogues.in. Contact no. 011-43720751