PMID- 28714741 OWN - NLM STAT- MEDLINE DCOM- 20171106 LR - 20221207 IS - 1744-7666 (Electronic) IS - 1465-6566 (Linking) VI - 18 IP - 12 DP - 2017 Aug TI - The efficacy and safety of adding either vildagliptin or glimepiride to ongoing metformin therapy in patients with type 2 diabetes mellitus. PG - 1179-1186 LID - 10.1080/14656566.2017.1353080 [doi] AB - OBJECTIVE: To compare the effects of either vildagliptin or glimepiride on glycemic variability, oxidative stress, and endothelial parameters in patients with type 2 diabetes mellitus (T2DM) inadequately controlled with metformin alone. METHODS: In this randomized, open-label, parallel study, 34 patients with T2DM being treated with metformin having an HbA1c of 7.0-10.0% were allocated into either the vildagliptin or glimepiride group. A mixed-meal tolerance test and 72-hour continuous glucose monitoring were conducted, and urinary 8-iso-prostaglandinF(2alpha) (PGF(2alpha)) and endothelial-dependent flow-mediated dilatation (FMD) were evaluated at baseline and after 12 weeks of treatment. RESULTS: Similar significant improvements in HbA1c level were shown in both vildagliptin (-0.8%) and glimepiride (-0.9%) groups after treatment (Ps<0.001). The mean amplitude of glycemic excursions (MAGE) and the mean of daily differences (MODD) were significantly decreased by vildagliptin (P = 0.044 and P = 0.031, respectively) but not by glimepiride. Glimepiride was significantly associated with a higher incidence of hypoglycemia than vildagliptin (P = 0.005). There were no significant differences in urinary 8-iso-PGF(2alpha) or FMD between the two groups. CONCLUSIONS: Vildagliptin effectively improved glucose level with a significantly greater reduction in glycemic variability and hypoglycemia than glimepiride in patients with T2DM ongoing metformin therapy. The two drugs showed no significant differences in urinary 8-iso-PGF(2alpha) and FMD. TRIAL REGISTRATION: NCT01404676. FAU - Kim, Gyuri AU - Kim G AD - a Division of Endocrinology and Metabolism, Department of Medicine , Samsung Medical Center, Sungkyunkwan University School of Medicine , Seoul , Republic of Korea. FAU - Oh, Sewon AU - Oh S AD - a Division of Endocrinology and Metabolism, Department of Medicine , Samsung Medical Center, Sungkyunkwan University School of Medicine , Seoul , Republic of Korea. FAU - Jin, Sang-Man AU - Jin SM AD - a Division of Endocrinology and Metabolism, Department of Medicine , Samsung Medical Center, Sungkyunkwan University School of Medicine , Seoul , Republic of Korea. FAU - Hur, Kyu Yeon AU - Hur KY AD - a Division of Endocrinology and Metabolism, Department of Medicine , Samsung Medical Center, Sungkyunkwan University School of Medicine , Seoul , Republic of Korea. FAU - Kim, Jae Hyeon AU - Kim JH AD - a Division of Endocrinology and Metabolism, Department of Medicine , Samsung Medical Center, Sungkyunkwan University School of Medicine , Seoul , Republic of Korea. FAU - Lee, Moon-Kyu AU - Lee MK AD - a Division of Endocrinology and Metabolism, Department of Medicine , Samsung Medical Center, Sungkyunkwan University School of Medicine , Seoul , Republic of Korea. LA - eng SI - ClinicalTrials.gov/NCT01404676 PT - Journal Article PT - Randomized Controlled Trial DEP - 20170717 PL - England TA - Expert Opin Pharmacother JT - Expert opinion on pharmacotherapy JID - 100897346 RN - 0 (Blood Glucose) RN - 0 (Glycated Hemoglobin A) RN - 0 (Hypoglycemic Agents) RN - 0 (Nitriles) RN - 0 (Pyrrolidines) RN - 0 (Sulfonylurea Compounds) RN - 0 (hemoglobin A1c protein, human) RN - 27415-26-5 (8-epi-prostaglandin F2alpha) RN - 6KY687524K (glimepiride) RN - 9100L32L2N (Metformin) RN - B7IN85G1HY (Dinoprost) RN - I6B4B2U96P (Vildagliptin) RN - PJY633525U (Adamantane) SB - IM MH - Adamantane/administration & dosage/adverse effects/*analogs & derivatives/therapeutic use MH - Blood Glucose/drug effects MH - Diabetes Mellitus, Type 2/*drug therapy MH - Dinoprost/analogs & derivatives/urine MH - Drug Therapy, Combination MH - Female MH - Glycated Hemoglobin/analysis MH - Humans MH - Hypoglycemia/chemically induced MH - Hypoglycemic Agents/administration & dosage/adverse effects/*therapeutic use MH - Male MH - Metformin/administration & dosage/adverse effects/*therapeutic use MH - Middle Aged MH - Nitriles/administration & dosage/adverse effects/*therapeutic use MH - Pyrrolidines/administration & dosage/adverse effects/*therapeutic use MH - Sulfonylurea Compounds/administration & dosage/adverse effects/*therapeutic use MH - Treatment Outcome MH - Vildagliptin OTO - NOTNLM OT - Continuous glucose monitoring OT - flow-mediated dilatation OT - glimepiride OT - mixed-meal tolerance test OT - oxidative stress OT - type 2 diabetes OT - vildagliptin EDAT- 2017/07/18 06:00 MHDA- 2017/11/07 06:00 CRDT- 2017/07/18 06:00 PHST- 2017/07/18 06:00 [pubmed] PHST- 2017/11/07 06:00 [medline] PHST- 2017/07/18 06:00 [entrez] AID - 10.1080/14656566.2017.1353080 [doi] PST - ppublish SO - Expert Opin Pharmacother. 2017 Aug;18(12):1179-1186. doi: 10.1080/14656566.2017.1353080. Epub 2017 Jul 17.