title: Efficacy and safety of switching from basal insulin to sitagliptin in Japanese type 2 diabetes patients.
abstract: Basal-supported oral therapy (BOT) is often used to treat poorly controlled type 2 diabetes. However, patients sometimes experience nocturnal and early morning hypoglycemia. Thus, maintaining targeted glycemic control by BOT is limited in some patients. We assessed the efficacy and safety of replacing basal insulin by sitagliptin therapy in Japanese type 2 diabetes patients on BOT. Forty-nine subjects were sequentially recruited for the 52-week, prospective, single arm study. Patients on BOT therapy were switched from basal insulin to sitagliptin. The primary endpoint was change in HbA1c in 52 weeks. The secondary endpoints were dropout rate, changes in body weight, frequency of hypoglycemia, and relationship between change in HbA1c and insulin secretion capacity evaluated by glucagon loading test. The average dose of basal insulin was 15.0±8.4 units. Sixteen subjects (31.3%) were dropped because replacement by sitagliptin was less effective for glycemic control. In these subjects, diabetes duration was longer, FPG and HbA1c at baseline were higher, and insulin secretion capacity was lower. Change in HbA1c in 52 weeks was - 4 mmol/mol (95% CI - 5 to - 4 mmol/mol) (p<0.05). Change in body weight was - 0.71 kg (95% CI - 1.42 to - 0.004 kg) (p<0.05). Frequency of hypoglycemia was decreased from 1.21±1.05 to 0.06±0.24 times/month. HbA1c level was improved if C-peptide index (CPI) was over 1.19. In conclusion, basal insulin in BOT can be replaced by sitagliptin with a decrease in HbA1c level and frequency of hypoglycemia in cases where insulin secretion capacity was sufficiently preserved.
authors.affiliation: Department of Diabetes and Clinical Nutrition, Graduate School of Medicine, Kyoto University, Kyoto 606-8507, Japan. harasima@metab.kuhp.kyoto-u.ac.jp
authors.forename: S-I
authors.initials: SI
authors.lastname: Harashima
authors.forename: D
authors.initials: D
authors.lastname: Tanaka
authors.forename: S
authors.initials: S
authors.lastname: Yamane
authors.forename: M
authors.initials: M
authors.lastname: Ogura
authors.forename: Y
authors.initials: Y
authors.lastname: Fujita
authors.forename: Y
authors.initials: Y
authors.lastname: Murata
authors.forename: M
authors.initials: M
authors.lastname: Seike
authors.forename: T
authors.initials: T
authors.lastname: Koizumi
authors.forename: M
authors.initials: M
authors.lastname: Aono
authors.forename: Y
authors.initials: Y
authors.lastname: Wang
authors.forename: N
authors.initials: N
authors.lastname: Inagaki
mesh_terms: D000368:Aged; D044466:Asian People; D015992:Body Mass Index; D001835:Body Weight / Q000187:drug effects; D002096:C-Peptide / Q000097:blood; D003710:Demography; D003924:Diabetes Mellitus, Type 2 / Q000150:complications / Q000188:drug therapy*; D004305:Dose-Response Relationship, Drug; D005260:Female; D006442:Glycated Hemoglobin / Q000378:metabolism; D006801:Humans; D007003:Hypoglycemia / Q000150:complications / Q000188:drug therapy; D007004:Hypoglycemic Agents / Q000008:administration & dosage / Q000009:adverse effects / Q000494:pharmacology / Q000627:therapeutic use*; D007328:Insulin / Q000008:administration & dosage / Q000009:adverse effects* / Q000494:pharmacology / Q000627:therapeutic use*; D007564:Japan; D008297:Male; D011719:Pyrazines / Q000008:administration & dosage / Q000009:adverse effects* / Q000494:pharmacology / Q000627:therapeutic use*; D012372:ROC Curve; D000068900:Sitagliptin Phosphate; D016896:Treatment Outcome; D014230:Triazoles / Q000008:administration & dosage / Q000009:adverse effects* / Q000494:pharmacology / Q000627:therapeutic use*
chemical_list: D002096:C-Peptide; D006442:Glycated Hemoglobin; D007004:Hypoglycemic Agents; D007328:Insulin; D011719:Pyrazines; D000068900:Sitagliptin Phosphate; D014230:Triazoles