title: Effects of transglucosidase on diabetes, cardiovascular risk factors and hepatic biomarkers in patients with type 2 diabetes: a 12-week, randomized, double-blind, placebo-controlled trial.
abstract: In this 12-week, randomized, double-blind, placebo-controlled trial, the efficacy and safety of transglucosidase (TGD) were compared with placebo in patients with type 2 diabetes mellitus (T2DM). At 12 weeks, TGD 300 mg/day and TGD 900 mg/day significantly reduced HbA1c (0.18 and 0.21%) and insulin concentration (19.4 and 25.0 pmol/l), respectively, vs. placebo. TGD 300 mg/day and TGD 900 mg/day also significantly reduced low-density lipoprotein cholesterol (0.22 and 0.17 mmol/l, respectively). TGD 900 mg/day significantly reduced triglyceride by 0.24 mmol/l and diastolic blood pressure by 8 mmHg. Placebo was associated with a significant increase from baseline in body mass index, alanine aminotransferase and aspartate aminotransferase (0.17 kg/m(2) , 3 and 2 U/l, respectively), whereas TGD was not. TGD 300 mg/day significantly increased high-molecular-weight adiponectin by 0.6 µg/ml. Adverse events did not differ significantly between the groups. TGD resulted in lowering of HbA1c and blood insulin level and improvements in metabolic and cardiovascular risk factors in T2DM.
authors.affiliation: Department of Gastroenterology, Aichi Medical University School of Medicine, 21 Karimata, Aichi-gun, Aichi, Japan. msasaki@aichi-med-u.ac.jp
authors.forename: M
authors.initials: M
authors.lastname: Sasaki
authors.forename: K
authors.initials: K
authors.lastname: Imaeda
authors.forename: N
authors.initials: N
authors.lastname: Okayama
authors.forename: T
authors.initials: T
authors.lastname: Mizuno
authors.forename: H
authors.initials: H
authors.lastname: Kataoka
authors.forename: T
authors.initials: T
authors.lastname: Kamiya
authors.forename: E
authors.initials: E
authors.lastname: Kubota
authors.forename: N
authors.initials: N
authors.lastname: Ogasawara
authors.forename: Y
authors.initials: Y
authors.lastname: Funaki
authors.forename: M
authors.initials: M
authors.lastname: Mizuno
authors.forename: A
authors.initials: A
authors.lastname: Iida
authors.forename: C
authors.initials: C
authors.lastname: Goto
authors.forename: S
authors.initials: S
authors.lastname: Koikeda
authors.forename: K
authors.initials: K
authors.lastname: Kasugai
authors.forename: T
authors.initials: T
authors.lastname: Joh
mesh_terms: D052242:Adiponectin / Q000097:blood; D000410:Alanine Transaminase / Q000097:blood; D001219:Aspartate Aminotransferases / Q000097:blood; D015415:Biomarkers / Q000097:blood; D001786:Blood Glucose / Q000187:drug effects* / Q000378:metabolism; D001794:Blood Pressure / Q000187:drug effects; D015992:Body Mass Index; D002318:Cardiovascular Diseases / Q000097:blood / Q000188:drug therapy / Q000209:etiology*; D008078:Cholesterol, LDL / Q000097:blood; D003924:Diabetes Mellitus, Type 2 / Q000097:blood / Q000188:drug therapy* / Q000378:metabolism; D004311:Double-Blind Method; D005260:Female; D005964:Glucosyltransferases / Q000627:therapeutic use*; D006442:Glycated Hemoglobin / Q000378:metabolism; D006801:Humans; D007004:Hypoglycemic Agents / Q000627:therapeutic use*; D007328:Insulin / Q000097:blood; D008099:Liver / Q000187:drug effects* / Q000378:metabolism; D008297:Male; D008875:Middle Aged; D012307:Risk Factors; D014280:Triglycerides / Q000097:blood
chemical_list: D052242:Adiponectin; D000410:Alanine Transaminase; D001219:Aspartate Aminotransferases; D015415:Biomarkers; D001786:Blood Glucose; D008078:Cholesterol, LDL; D005964:Glucosyltransferases; D006442:Glycated Hemoglobin; D007004:Hypoglycemic Agents; D007328:Insulin; D014280:Triglycerides; C517652:hemoglobin A1c protein, human