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.
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 HbAlc 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.
authors.affiliation: Department of Internal Medicine, College of Medicine, Bucheon St. Mary's Hospital, The Catholic University of Korea, Bucheon, Korea.
authors.forename: Jang-Won
authors.initials: JW
authors.lastname: Son
authors.forename: In-Kyu
authors.initials: IK
authors.lastname: Lee
authors.forename: Jeong-taek
authors.initials: JT
authors.lastname: Woo
authors.forename: Sei Hyun
authors.initials: SH
authors.lastname: Baik
authors.forename: Hak Chul
authors.initials: HC
authors.lastname: Jang
authors.forename: Kwan Woo
authors.initials: KW
authors.lastname: Lee
authors.forename: Bong Soo
authors.initials: BS
authors.lastname: Cha
authors.forename: Yeon-Ah
authors.initials: YA
authors.lastname: Sung
authors.forename: Tae Sun
authors.initials: TS
authors.lastname: Park
authors.forename: Soon-Jib
authors.initials: SJ
authors.lastname: Yoo
authors.forename: Kun-Ho
authors.initials: KH
authors.lastname: Yoon
mesh_terms: D000328:Adult; D001786:Blood Glucose / Q000032:analysis; D015992:Body Mass Index; D003924:Diabetes Mellitus, Type 2 / Q000097:blood / Q000188:drug therapy*; D005215:Fasting; D005260:Female; D006442:Glycated Hemoglobin / Q000032:analysis; D006801:Humans; D007004:Hypoglycemic Agents; D007294:Inositol / Q000008:administration & dosage / Q000031:analogs & derivatives*; D000069036:Insulin Glargine / Q000008:administration & dosage* / Q000627:therapeutic use; D054833:Isoindoles / Q000008:administration & dosage*; D008297:Male; D008875:Middle Aged; D011446:Prospective Studies
chemical_list: D001786:Blood Glucose; D006442:Glycated Hemoglobin; D007004:Hypoglycemic Agents; D007294:Inositol; D000069036:Insulin Glargine; D054833:Isoindoles; C087255:mitiglinide; C102817:voglibose