PMID- 25190226
OWN - NLM
STAT- MEDLINE
DCOM- 20141117
LR  - 20221207
IS  - 1744-7666 (Electronic)
IS  - 1465-6566 (Linking)
VI  - 15
IP  - 15
DP  - 2014 Oct
TI  - Efficacy and safety of alogliptin added to insulin in Japanese patients with type 
      2 diabetes: a randomized, double-blind, 12-week, placebo-controlled trial 
      followed by an open-label, long-term extension phase.
PG  - 2121-30
LID - 10.1517/14656566.2014.956722 [doi]
AB  - OBJECTIVE: To evaluate the efficacy and safety of alogliptin added to insulin in 
      Japanese patients with type 2 diabetes mellitus (T2DM) who are poorly controlled 
      with insulin and diet or exercise. STUDY DESIGN: This was a randomized, 
      double-blind, 12-week comparative trial of alogliptin and insulin versus placebo 
      and insulin in 179 patients with T2DM followed by a 40-week, open-label phase in 
      169 patients on alogliptin and insulin. PRIMARY OUTCOME MEASURE: Change in 
      glycated hemoglobin (HbA1c) from baseline to the end of double-blind phase (week 
      12). RESULTS: The change in HbA1c (least squares means) from baseline to week 12 
      was -0.96% for the alogliptin and insulin group and -0.29% for the placebo and 
      insulin group. The point estimate (95% confidence interval) intergroup difference 
      was -0.66% ([-0.824%, -0.503%]). In the alogliptin and insulin group, HbA1c 
      started to decrease from week 2 onward and peaked by week 12. The proportions of 
      patients who achieved HbA1c < 8.0, < 7.0 and < 6.0% at week 12 were significantly 
      higher in alogliptin and insulin group (73.0, 23.3 and 1.1%) than in placebo and 
      insulin group (25.0, 5.7 and 0%). Incidences of adverse effects were comparable 
      between groups, with no relevant increases in hypoglycemia or weight gain seen. 
      CONCLUSIONS: Alogliptin 25 mg/day was effective and well tolerated when added to 
      insulin in Japanese patients with inadequately controlled T2DM.
FAU - Kaku, Kohei
AU  - Kaku K
AD  - Kawasaki Medical School , 577, Matsushima, Kurashiki-shi, Okayama 701-0192 , 
      Japan +81 86 462 1111 ; +81 86 462 1199 ; kka@med.kawasaki-m.ac.jp.
FAU - Mori, Mikiko
AU  - Mori M
FAU - Kanoo, Tatsuhiro
AU  - Kanoo T
FAU - Katou, Masafumi
AU  - Katou M
FAU - Seino, Yutaka
AU  - Seino Y
LA  - eng
SI  - ClinicalTrials.gov/NCT01521962
PT  - Journal Article
PT  - Randomized Controlled Trial
PT  - Research Support, Non-U.S. Gov't
DEP - 20140905
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 (Insulin)
RN  - 0 (Piperidines)
RN  - 0 (hemoglobin A1c protein, human)
RN  - 56HH86ZVCT (Uracil)
RN  - JHC049LO86 (alogliptin)
SB  - IM
MH  - Aged
MH  - Blood Glucose/analysis
MH  - Diabetes Mellitus, Type 2/*drug therapy/epidemiology
MH  - Double-Blind Method
MH  - Drug Therapy, Combination
MH  - Female
MH  - Glycated Hemoglobin/analysis
MH  - Humans
MH  - Hypoglycemia/chemically induced
MH  - Hypoglycemic Agents/*adverse effects/therapeutic use
MH  - Insulin/adverse effects/*therapeutic use
MH  - Japan/epidemiology
MH  - Male
MH  - Middle Aged
MH  - Piperidines/*adverse effects/therapeutic use
MH  - Placebo Effect
MH  - Uracil/adverse effects/*analogs & derivatives/therapeutic use
MH  - Weight Gain/drug effects
OTO - NOTNLM
OT  - Japanese patients
OT  - alogliptin
OT  - clinical trial
OT  - insulin
OT  - type 2 diabetes mellitus
EDAT- 2014/09/06 06:00
MHDA- 2014/11/18 06:00
CRDT- 2014/09/06 06:00
PHST- 2014/09/06 06:00 [entrez]
PHST- 2014/09/06 06:00 [pubmed]
PHST- 2014/11/18 06:00 [medline]
AID - 10.1517/14656566.2014.956722 [doi]
PST - ppublish
SO  - Expert Opin Pharmacother. 2014 Oct;15(15):2121-30. doi: 
      10.1517/14656566.2014.956722. Epub 2014 Sep 5.