title: Efficacy and safety of coadministration of sitagliptin with insulin glargine in type 2 diabetes.
abstract: BACKGROUND
  The aim of the randomized present study was to compare the therapeutic efficacy and safety of a combination of sitagliptin, a dipeptidyl peptidase (DPP)-4 inhibitor, plus insulin glargine (GL + sita) with that of premixed insulin aspart 30 (NOV) for type 2 diabetes (T2D) patients controlled with oral hypoglycemic drugs (HbA1c 7 %-9 %).
  
  
  METHODS
  Sixty-five patients were randomized (1:  1) to the GL + sita (n = 33) and NOV (n = 32) groups and were treated with the combination regimen or premixed insulin twice a day for 16 weeks. The primary endpoint was mean change in HbA1c. Secondary endpoints included fasting blood glucose, blood glucose profiles (seven time points), rate of achieving target HbA1c (<7 % or ≤6.5 %), insulin dose, incidence of hypoglycemia, and body weight.
  
  
  RESULTS
  After 16 weeks, there was no significant difference in HbA1c between the two groups, although more patients achieved HbA1c <7.0 % in the GL + sita group. There was a significant difference in body weight changes between the GL + sita and NOV groups (-0.45 vs 1.52 kg, respectively; P < 0.001). Mean plasma glucose and the mean amplitude of glycemic excursion were significantly lower in the GL + sita than NOV group (P < 0.005), as was the incidence of symptomatic hypoglycemia (2.85 % vs. 13.3 %, respectively; P < 0.001).
  
  
  CONCLUSIONS
  The combination of GL + sita greatly improved HbA1c in T2D patients (HbA1c 7 %-9 %) with an efficacy that was equal to that of premixed insulin. Thus, GL + sita treatment is a viable option for patients who fail to achieve glycemic control using oral hypoglycemic drugs.
authors.affiliation: Department of Endocrinology, Nanfang Hospital, Southern Medical University, Guangzhou, China.
authors.forename: Ying
authors.initials: Y
authors.lastname: Cao
authors.affiliation: Department of Endocrinology, Nanfang Hospital, Southern Medical University, Guangzhou, China.
authors.forename: Fang
authors.initials: F
authors.lastname: Gao
authors.affiliation: Department of Endocrinology, Nanfang Hospital, Southern Medical University, Guangzhou, China.
authors.forename: Qian
authors.initials: Q
authors.lastname: Zhang
authors.affiliation: Department of Endocrinology, Nanfang Hospital, Southern Medical University, Guangzhou, China.
authors.forename: Lingling
authors.initials: L
authors.lastname: Xu
authors.affiliation: Department of Endocrinology, Nanfang Hospital, Southern Medical University, Guangzhou, China.
authors.forename: Qian
authors.initials: Q
authors.lastname: Wan
authors.affiliation: Department of Endocrinology, Nanfang Hospital, Southern Medical University, Guangzhou, China.
authors.forename: Wenqi
authors.initials: W
authors.lastname: Li
authors.affiliation: Department of Endocrinology, Nanfang Hospital, Southern Medical University, Guangzhou, China.
authors.forename: Jimin
authors.initials: J
authors.lastname: Li
authors.affiliation: Department of Endocrinology, Nanfang Hospital, Southern Medical University, Guangzhou, China.
authors.forename: Ling
authors.initials: L
authors.lastname: Wang
authors.affiliation: Department of Endocrinology, Nanfang Hospital, Southern Medical University, Guangzhou, China.
authors.forename: Yaoming
authors.initials: Y
authors.lastname: Xue
mesh_terms: D000328:Adult; D001786:Blood Glucose / Q000032:analysis; D015190:Blood Glucose Self-Monitoring / Q000379:methods; D002096:C-Peptide / Q000097:blood; D003924:Diabetes Mellitus, Type 2 / Q000097:blood / Q000188:drug therapy*; D004334:Drug Administration Schedule; D004359:Drug Therapy, Combination; D005260:Female; D005500:Follow-Up Studies; D006442:Glycated Hemoglobin / Q000032:analysis; D006801:Humans; D007004:Hypoglycemic Agents / Q000008:administration & dosage / Q000009:adverse effects / Q000627:therapeutic use; D000069036:Insulin Glargine / Q000008:administration & dosage / Q000009:adverse effects / Q000627:therapeutic use*; D008297:Male; D008875:Middle Aged; D000068900:Sitagliptin Phosphate / Q000008:administration & dosage / Q000009:adverse effects / Q000627:therapeutic use*; D016896:Treatment Outcome
chemical_list: D001786:Blood Glucose; D002096:C-Peptide; D006442:Glycated Hemoglobin; D007004:Hypoglycemic Agents; D000069036:Insulin Glargine; D000068900:Sitagliptin Phosphate
keywords: 2型糖尿病; dipeptidyl peptidase-4 inhibitor; insulin; sitagliptin; type 2 diabetes; 二肽基肽酶-4抑制剂; 胰岛素; 西格列汀