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A prospective, randomized, multicenter trial comparing the efficacy and safety of the concurrent use of long-acting insulin with mitiglinide or voglibose in patients with type 2 diabetes

Title
A prospective, randomized, multicenter trial comparing the efficacy and safety of the concurrent use of long-acting insulin with mitiglinide or voglibose in patients with type 2 diabetes
Authors
Son, Jang-WonLee, In-KyuWoo, Jeong-taekBaik, Sei HyunJang, Hak ChulLee, Kwan WooCha, Bong SooSung, Yeon-AhPark, Tae SunYoo, Soon-JibYoon, Kun-Ho
Ewha Authors
성연아
SCOPUS Author ID
성연아scopus
Issue Date
2015
Journal Title
ENDOCRINE JOURNAL
ISSN
0918-8959JCR Link1348-4540JCR Link
Citation
vol. 62, no. 12, pp. 1049 - 1057
Keywords
Diabetes mellitusType 2MitiglinideVoglibose
Publisher
JAPAN ENDOCRINE SOC
Indexed
SCI; SCIE; SCOPUS WOS scopus
Abstract
This trial was conducted to compare the efficacy and safety of combination therapy with basal insulin glargine plus mitiglinide to that of basal insulin glargine plus voglibosein patients with type 2 diabetes. This was a 20-week, randomized, multicenter non-inferiority trial. Patients with HbA1c levels over 7.0% were randomly assigned to receive either mitiglinide (10 mg tid) or voglibose (0.2 mg tid) concurrent with insulin glargine for 16 weeks after a 4-week of basal insulin glargine monotherapy. The intention-to-treat population included 156 patients; 79 were placed in the mitiglinide group, and 77 were placed in the voglibose group. At 20 weeks, there was no significant difference between the mitiglinide group and the voglibose group in terms of the mean HbA1c level or the mean decrease of the HbA1c level from baseline (-0.9% [-7.5 mmol/mol] and 0.7%, [-5.3 mmol/mol] respectively). The mean fasting plasma glucose level and data of self-monitoring blood glucosewere significantly decreased from baseline to week 20 in both groups, but there was no significant difference between the two groups. The changes in the basal insulin requirements of each group were not significant. The prevalence of adverse events and the risk of hypoglycemia were similar for both groups. Combination therapy with mitiglinide plus basal insulin glargine was non-inferior to voglibose plus basal insulin glargine in terms of the effect on overall glycemic control.
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