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Comparison of vildagliptin and acarbose monotherapy in patients with Type 2 diabetes: a 24‐week, double‐blind, randomized trial
Author(s) -
Pan C.,
Yang W.,
Barona J. P.,
Wang Y.,
Niggli M.,
Mohideen P.,
Wang Y.,
Foley J. E.
Publication year - 2008
Publication title -
diabetic medicine
Language(s) - English
Resource type - Journals
SCImago Journal Rank - 1.474
H-Index - 145
eISSN - 1464-5491
pISSN - 0742-3071
DOI - 10.1111/j.1464-5491.2008.02391.x
Subject(s) - vildagliptin , acarbose , medicine , tolerability , type 2 diabetes , diabetes mellitus , gastroenterology , adverse effect , endocrinology , dipeptidyl peptidase 4 inhibitor , randomized controlled trial
Aims To compare the efficacy and tolerability of the dipeptidyl peptidase‐4 inhibitor, vildagliptin, with the alpha glucosidase inhibitor, acarbose, in drug‐naive patients with Type 2 diabetes. Methods This multi‐centre, randomized, double‐blind, parallel‐arm study compared the efficacy and tolerability of vildagliptin (100 mg daily, given as 50 mg twice daily, n = 441) and acarbose (up to 300 mg daily, given as three equally divided doses, n = 220) during 24‐week treatment in drug‐naive patients with Type 2 diabetes. Results Monotherapy with vildagliptin or acarbose decreased glycated haemoglobin (HbA 1c ) (baseline ≈ 8.6%) to a similar extent during 24‐week treatment. The adjusted mean change from baseline to end‐point (AMΔ) in HbA 1c was −1.4 ± 0.1% and −1.3 ± 0.1% in patients receiving vildagliptin and acarbose, respectively, meeting the statistical criterion for non‐inferiority (upper limit of 95% confidence interval for between‐treatment difference ≤ 0.4%). The decrease in fasting plasma glucose was similar with acarbose (−1.5 ± 0.2 mmol/l) and vildagliptin (−1.2 ± 0.1 mmol/l). Body weight did not change in vildagliptin‐treated patients (−0.4 ± 0.1 kg) but decreased in acarbose‐treated patients (−1.7 ± 0.2 kg, P < 0.001 vs. vildagliptin). The proportion of patients experiencing any adverse event (AE) was 35% vs. 51% in patients receiving vildagliptin or acarbose, respectively; gastrointestinal AEs were significantly more frequent with acarbose (25.5%) than vildagliptin (12.3%, P < 0.001). No hypoglycaemia was reported for either group. Conclusions Vildagliptin is effective and well tolerated in patients with Type 2 diabetes, demonstrating similar glycaemic reductions to acarbose, but with better tolerability.