Comparative study of sitagliptin with pioglitazone in Japanese type 2 diabetic patients: the COMPASS randomized controlled trial. Issue 5 (24th January 2013)

• Record Type: Journal Article
• Authors: Takihata, M.; Nakamura, A.; Tajima, K.; Inazumi, T.; Komatsu, Y.; Tamura, H.; Yamazaki, S.; Kondo, Y.; Yamada, M.; Kimura, M.; Terauchi, Y.
• Is Part Of: Diabetes, obesity & metabolism. Volume 15:Issue 5(2013:May)
• Page Start: 455
• Page End: 462
• Publication Date: 2013-01-24
• Subjects: Diabetes -- Periodicals; Obesity -- Periodicals; Metabolism -- Disorders -- Periodicals; Clinical pharmacology -- Periodicals; 616.462
• DOI: 10.1111/dom.12055
• Languages: English
• ISSNs: 1462-8902

Abstract

<abstract abstract-type="main"> <title>Abstract</title> <sec id="dom12055-sec-0001" sec-type="section"> <title>Aims</title> <p>To compare the efficacy and safety of these two agents and the impact on surrogate markers related to diabetic complications in Japanese type 2 diabetic patients.</p> </sec> <sec id="dom12055-sec-0002" sec-type="section"> <title>Methods</title> <p>In a multicenter, open‐label trial, 130 patients whose diabetes had been inadequately controlled (HbA1c, 6.9–9.5%) with metformin and/or sulphonylurea were randomly assigned to a sitagliptin group (50 mg/day) or a pioglitazone group (15 mg/day) and were followed up for 24 weeks. At 16 weeks, if the patient's HbA1c level was ≥6.5%, the dose of sitagliptin or pioglitazone was increased up to 100 or 30 mg/day, respectively. Main outcome measure was the difference in the mean changes in the HbA1c level from baseline at 24 weeks between these two groups.</p> </sec> <sec id="dom12055-sec-0003" sec-type="section"> <title>Results</title> <p>Of the 130 patients who were enrolled, 115 subjects (sitagliptin group: 58 patients, pioglitazone group: 57 patients) completed this trial. At 0 weeks, the mean HbA1c level was 7.47 ± 0.66% in the sitagliptin group and 7.40 ± 0.61% in the pioglitazone group. At 24 weeks, the mean changes in the HbA1c level from baseline were −0.86 ± 0.63% versus −0.58 ± 0.68% (p = 0.024). Hypoglycaemia (2 patients, 3.4% vs. 2 patients, 3.5%), gastrointestinal symptoms (3 patients, 5.2% vs. 1 patient, 1.8%) and pretibial oedema (0 patients, 0% vs. 39 patients, 68.4%, p < 0.001) were observed for 24 weeks.</p> </sec> <sec id="dom12055-sec-0004" sec-type="section"> <title>Conclusions</title> <p>Sitagliptin was not only more tolerable, but also more effective than pioglitazone in Japanese type 2 diabetic patients who had been treated with metformin and/or sulphonylurea.</p> </sec> </abstract>