title: Comparison of vildagliptin as an add-on therapy and sulfonylurea dose-increasing therapy in patients with inadequately controlled type 2 diabetes using metformin and sulfonylurea (VISUAL study): A randomized trial.
abstract: The aim of present study is to compare the efficacy and safety of adding vildagliptin with sulfonylurea dose-increasing as an active comparator in patients who had inadequately controlled type 2 diabetes mellitus (T2DM) using metformin plus sulfonylurea in real clinical practice. Patients using metformin plus sulfonylurea were assigned to either vildagliptin add-on (50 mg twice a day, n=172) or sulfonylurea dose-increasing by 50% (n=172) treatment groups. The primary endpoint was a change in HbA(1c) after 24 weeks. The secondary endpoints were patients achieving HbA(1c)≤7.0% (53 mmol/mol) and changes in the fasting plasma glucose (FPG), 2-h postprandial glucose (2pp), lipid profiles, and urine albumin-to-creatinine ratio. Body weight and hypoglycemia were also investigated. The mean HbA(1c) at baseline was 8.6% (70 mmol/mol) in both groups. At week 24, the adjusted mean HbA(1c) levels decreased by -1.19% (-13.09 mmol/mol) with vildagliptin add-on and -0.46% (-5.06 mmol/mol) with sulfonylurea (P<0.001). Significantly more vildagliptin add-on patients achieved HbA(1c)≤7.0% (53 mmol/mol) than did sulfonylurea patients (40.1% vs. 7.9%; P<0.001). Greater reductions in FPG and 2pp were observed with vildagliptin add-on than with sulfonylurea (P<0.001). The vildagliptin add-on group exhibited no clinically relevant weight gain and had a lower incidence of hypoglycemia compared with the sulfonylurea group. Vildagliptin add-on therapy might be a suitable option for patients with T2DM that is controlled inadequately by metformin and sulfonylurea, based on its greater glucose control and better safety profile (ClinicalTrial.gov: NCT01099137).
authors.affiliation: Department of Internal Medicine, Seoul National University Bundang Hospital, Seongnam, South Korea; Seoul National University College of Medicine, Seoul, South Korea.
authors.forename: A Ram
authors.initials: AR
authors.lastname: Hong
authors.affiliation: Seoul National University College of Medicine, Seoul, South Korea; Department of Internal Medicine, Seoul National University Hospital, Seoul, South Korea.
authors.forename: Jeun
authors.initials: J
authors.lastname: Lee
authors.affiliation: Department of Internal Medicine, Seoul National University Bundang Hospital, Seongnam, South Korea; Seoul National University College of Medicine, Seoul, South Korea.
authors.forename: Eu Jeong
authors.initials: EJ
authors.lastname: Ku
authors.affiliation: Seoul National University College of Medicine, Seoul, South Korea; Department of Internal Medicine, Seoul National University Hospital, Seoul, South Korea.
authors.forename: Yul
authors.initials: Y
authors.lastname: Hwangbo
authors.affiliation: Department of Internal Medicine, Seoul National University Bundang Hospital, Seongnam, South Korea; Seoul National University College of Medicine, Seoul, South Korea.
authors.forename: Kyoung Min
authors.initials: KM
authors.lastname: Kim
authors.affiliation: Department of Internal Medicine, Seoul National University Bundang Hospital, Seongnam, South Korea; Seoul National University College of Medicine, Seoul, South Korea.
authors.forename: Jae Hoon
authors.initials: JH
authors.lastname: Moon
authors.affiliation: Department of Internal Medicine, Seoul National University Bundang Hospital, Seongnam, South Korea; Seoul National University College of Medicine, Seoul, South Korea.
authors.forename: Sung Hee
authors.initials: SH
authors.lastname: Choi
authors.affiliation: Department of Internal Medicine, Seoul National University Bundang Hospital, Seongnam, South Korea; Seoul National University College of Medicine, Seoul, South Korea.
authors.forename: Hak Chul
authors.initials: HC
authors.lastname: Jang
authors.affiliation: Department of Internal Medicine, Seoul National University Bundang Hospital, Seongnam, South Korea; Seoul National University College of Medicine, Seoul, South Korea. Electronic address: limsoo@snu.ac.kr.
authors.forename: Soo
authors.initials: S
authors.lastname: Lim
mesh_terms: D000218:Adamantane / Q000008:administration & dosage / Q000009:adverse effects / Q000031:analogs & derivatives*; D000368:Aged; D001786:Blood Glucose / Q000187:drug effects / Q000378:metabolism*; D003924:Diabetes Mellitus, Type 2 / Q000097:blood / Q000188:drug therapy* / Q000453:epidemiology; D004305:Dose-Response Relationship, Drug; D004359:Drug Therapy, Combination; D005260:Female; D006442:Glycated Hemoglobin / Q000187:drug effects / Q000378:metabolism; D006801:Humans; D007003:Hypoglycemia / Q000139:chemically induced / Q000453:epidemiology; D007004:Hypoglycemic Agents / Q000008:administration & dosage* / Q000009:adverse effects; D008297:Male; D008687:Metformin / Q000008:administration & dosage* / Q000009:adverse effects; D008875:Middle Aged; D009570:Nitriles / Q000008:administration & dosage* / Q000009:adverse effects; D011759:Pyrrolidines / Q000008:administration & dosage* / Q000009:adverse effects; D013453:Sulfonylurea Compounds / Q000008:administration & dosage*; D000077597:Vildagliptin
chemical_list: D000218:Adamantane; D001786:Blood Glucose; D006442:Glycated Hemoglobin; D007004:Hypoglycemic Agents; D008687:Metformin; D009570:Nitriles; D011759:Pyrrolidines; D013453:Sulfonylurea Compounds; D000077597:Vildagliptin
keywords: Clinical trial; Hypoglycemia; Sulfonylurea; Vildagliptin