title: Efficacy and safety of sitagliptin as add-on therapy on glycemic control and blood glucose fluctuation in Japanese type 2 diabetes subjects ongoing with multiple daily insulin injections therapy.
abstract: To assess the efficacy and safety of adding sitagliptin, an oral dipeptidyl peptidase-4 inhibitor, in subjects with type 2 diabetes inadequately controlled with multiple daily insulin injections therapy (MDI). HbA1c, 1,5-anhydroglucitol (1,5-AG), body mass index (BMI), insulin doses, six-point self-measured plasma glucose (SMPG) profiles were assessed before, after 12 weeks, and after 24 weeks of MDI with 50 mg/day of sitagliptin in 40 subjects with type 2 diabetes. Safety endpoints included hypoglycemia and any adverse events. HbA1c significantly decreased during the first 12 weeks ( -0.64±0.60%), and was sustained over 24 weeks ( -0.69±0.85%). 1,5-AG increased significantly from 7.5±4.5 μg/mL at baseline to 9.6±5.5 μg/mL after 24 weeks. The bolus insulin dose at 12 weeks was decreased, and the mean plasma glucose, the SD of daily glucose, M-value, and the mean amplitude of glycemic excursions (MAGE) also decreased significantly as compared with baseline values. BMI and frequency of hypoglycemia were not changed significantly. Univariate linear regression analyses revealed that % change in HbA1c was significantly associated with BMI, and % changes in the indexes of glycemic instability (SD of daily glucose and MAGE) were significantly associated with age. In conclusion, adding sitagliptin to MDI significantly improved glycemic control and decreased the daily glucose fluctuation in subjects with type 2 diabetes inadequately controlled with MDI, without weight gain or an increase in the incidence of hypoglycemia. This trial was registered with UMIN (no. UMIN000010157).
authors.affiliation: Department of Metabolic Medicine, Faculty of Life Sciences, Kumamoto University, Kumamoto 860-8556, Japan.
authors.forename: Seiya
authors.initials: S
authors.lastname: Shimoda
authors.forename: Shinsuke
authors.initials: S
authors.lastname: Iwashita
authors.forename: Shinji
authors.initials: S
authors.lastname: Ichimori
authors.forename: Yasuto
authors.initials: Y
authors.lastname: Matsuo
authors.forename: Rieko
authors.initials: R
authors.lastname: Goto
authors.forename: Takako
authors.initials: T
authors.lastname: Maeda
authors.forename: Tomoko
authors.initials: T
authors.lastname: Matsuo
authors.forename: Taiji
authors.initials: T
authors.lastname: Sekigami
authors.forename: Junji
authors.initials: J
authors.lastname: Kawashima
authors.forename: Tatsuya
authors.initials: T
authors.lastname: Kondo
authors.forename: Takeshi
authors.initials: T
authors.lastname: Matsumura
authors.forename: Hiroyuki
authors.initials: H
authors.lastname: Motoshima
authors.forename: Noboru
authors.initials: N
authors.lastname: Furukawa
authors.forename: Kenro
authors.initials: K
authors.lastname: Nishida
authors.forename: Eiichi
authors.initials: E
authors.lastname: Araki
mesh_terms: D000368:Aged; D044466:Asian People; D001786:Blood Glucose / Q000187:drug effects* / Q000378:metabolism; D015190:Blood Glucose Self-Monitoring; D015992:Body Mass Index; D003847:Deoxyglucose / Q000097:blood; D003924:Diabetes Mellitus, Type 2 / Q000188:drug therapy; D054873:Dipeptidyl-Peptidase IV Inhibitors / Q000627:therapeutic use*; D005260:Female; D006442:Glycated Hemoglobin / Q000378:metabolism; D006801:Humans; D007003:Hypoglycemia / Q000139:chemically induced; D007004:Hypoglycemic Agents / Q000009:adverse effects / Q000627:therapeutic use; D007328:Insulin / Q000008:administration & dosage / Q000627:therapeutic use; D008297:Male; D008875:Middle Aged; D011719:Pyrazines / Q000009:adverse effects / Q000627:therapeutic use*; D000068900:Sitagliptin Phosphate; D014230:Triazoles / Q000009:adverse effects / Q000627:therapeutic use*
chemical_list: D001786:Blood Glucose; D003847:Deoxyglucose; D054873:Dipeptidyl-Peptidase IV Inhibitors; D006442:Glycated Hemoglobin; D007004:Hypoglycemic Agents; D007328:Insulin; D011719:Pyrazines; D000068900:Sitagliptin Phosphate; D014230:Triazoles; C006584:1,5-anhydroglucitol