PMID- 26620049
OWN - NLM
STAT- PubMed-not-MEDLINE
LR  - 20200929
IS  - 1869-6953 (Print)
IS  - 1869-6961 (Electronic)
IS  - 1869-6961 (Linking)
VI  - 6
IP  - 4
DP  - 2015 Dec
TI  - Efficacy and Safety of Vildagliptin as an Add-on to Insulin with or without 
      Metformin in Japanese Patients with Type 2 Diabetes Mellitus: A 12-week, 
      Double-Blind, Randomized Study.
PG  - 559-571
AB  - INTRODUCTION: To assess the efficacy and safety of vildagliptin as add-on therapy 
      in Japanese patients with type 2 diabetes mellitus (T2DM), inadequately 
      controlled on stable long-acting, intermediate-acting, or pre-mixed insulin, with 
      or without concomitant metformin. METHODS: In this 12-week placebo-controlled 
      study, patients were randomized to receive either vildagliptin 50 mg twice daily 
      (bid) or placebo treatment in a 1:1 ratio. The primary endpoint was change in 
      glycated hemoglobin A1c (HbA1c) from baseline to 12-week endpoint. Secondary 
      endpoints included proportion of patients achieving pre-defined HbA1c targets of 
      </=6.5%, <7.0%, and HbA1c <7.0% in patients with baseline HbA1c </=8.0% and change in 
      fasting plasma glucose (FPG) after 12 weeks of treatment. Regular monitoring was 
      performed to record any treatment-emergent adverse events (AEs) and serious 
      adverse events or hypoglycemic episodes. RESULTS: Of the 156 patients randomized, 
      96.8% completed the study (vildagliptin, n = 76; placebo, n = 75). Patient 
      demographics and clinical characteristics were comparable between the groups at 
      baseline. Addition of vildagliptin resulted in statistically significant 
      reductions in HbA1c after 12 weeks (-1.01 +/- 0.06%), with a between-treatment 
      difference of -0.91 +/- 0.09% (p < 0.001). FPG levels reduced from baseline to 
      12 weeks in the vildagliptin group (-1.2 +/- 0.2 mmol/L), with a between-treatment 
      difference of -1.2 +/- 0.3 mmol/L which was significant (p < 0.001). The proportion 
      of patients achieving HbA1c targets was higher with vildagliptin treatment for 
      all pre-defined responder rate categories. The overall incidence of AEs was 
      comparable between groups (vildagliptin, 46.2% vs. placebo, 43.6%). The overall 
      incidence of hypoglycemic events was low and all events were self-treatable 
      without using drug therapy. No severe hypoglycemic events were reported. 
      CONCLUSION: Treatment with vildagliptin 50 mg bid as add-on to insulin with or 
      without metformin resulted in statistically significant reductions in HbA1c in 
      Japanese patients with T2DM. Overall, vildagliptin was well tolerated with a 
      safety profile similar to that of placebo in this patient population. 
      ClinicalTrials.gov Identifier, NCT02002221 FUNDING: Novartis Pharma K.K.
FAU - Hirose, Takahisa
AU  - Hirose T
AD  - Division of Diabetes, Metabolism and Endocrinology, Department of Medicine, Toho 
      University School of Medicine, Tokyo, Japan. takahisa.hirose@med.toho-u.ac.jp.
FAU - Suzuki, Manabu
AU  - Suzuki M
AD  - Development Division, Clinical Development, Cardio-Metabolic Clinical Franchise 
      Department, Novartis Pharma KK, Tokyo, Japan.
FAU - Tsumiyama, Isao
AU  - Tsumiyama I
AD  - Development Division, Clinical Development, Biometrics and Statistical Sciences 
      Department, Novartis Pharma KK, Tokyo, Japan.
LA  - eng
SI  - ClinicalTrials.gov/NCT02002221
PT  - Journal Article
DEP - 20151130
PL  - United States
TA  - Diabetes Ther
JT  - Diabetes therapy : research, treatment and education of diabetes and related 
      disorders
JID - 101539025
PMC - PMC4674469
OTO - NOTNLM
OT  - Hypoglycemia
OT  - Insulin
OT  - Japanese
OT  - Type 2 diabetes mellitus
OT  - Vildagliptin
EDAT- 2015/12/02 06:00
MHDA- 2015/12/02 06:01
PMCR- 2015/11/30
CRDT- 2015/12/02 06:00
PHST- 2015/10/05 00:00 [received]
PHST- 2015/12/02 06:00 [entrez]
PHST- 2015/12/02 06:00 [pubmed]
PHST- 2015/12/02 06:01 [medline]
PHST- 2015/11/30 00:00 [pmc-release]
AID - 10.1007/s13300-015-0147-6 [pii]
AID - 147 [pii]
AID - 10.1007/s13300-015-0147-6 [doi]
PST - ppublish
SO  - Diabetes Ther. 2015 Dec;6(4):559-571. doi: 10.1007/s13300-015-0147-6. Epub 2015 
      Nov 30.