PMID- 26816604
OWN - NLM
STAT- MEDLINE
DCOM- 20161024
LR  - 20221207
IS  - 2040-1124 (Electronic)
IS  - 2040-1116 (Print)
IS  - 2040-1116 (Linking)
VI  - 7
IP  - 1
DP  - 2016 Jan
TI  - Liraglutide is effective and well tolerated in combination with an oral 
      antidiabetic drug in Japanese patients with type 2 diabetes: A randomized, 
      52-week, open-label, parallel-group trial.
PG  - 76-84
LID - 10.1111/jdi.12367 [doi]
AB  - INTRODUCTION: The safety and efficacy of liraglutide in combination with an oral 
      antidiabetic drug (OAD) compared with combination of two OADs were assessed in 
      Japanese patients with type 2 diabetes. MATERIALS AND METHODS: This was a 
      52-week, open-label, parallel-group trial in which patients whose type 2 diabetes 
      was inadequately controlled with a single OAD (glinide, metformin, alpha-glucosidase 
      inhibitor or thiazolidinedione) were randomized 2:1 to either pretrial OAD in 
      combination with liraglutide 0.9 mg/day (liraglutide group; n = 240) or pretrial 
      OAD in combination with an additional OAD (additional OAD group; n = 120). The 
      primary outcome measure was the incidence of adverse events (AEs). RESULTS: 
      Overall, 86.3% of patients in the liraglutide group and 85.0% of patients in the 
      additional OAD group experienced AEs; these were similar in nature and severity. 
      Adverse event rates were 361 and 331 per 100 patient-years of exposure, 
      respectively. Confirmed hypoglycemia was rare (seven episodes in two patients on 
      liraglutide, and two in two patients on additional OAD). There were no reported 
      pancreatitis events, and no unexpected safety signals were identified. Mean 
      reductions in glycosylated hemoglobin were significantly greater in the 
      liraglutide group than the additional OAD group [estimated mean treatment 
      difference -0.27% (95% confidence interval (CI) -0.44, -0.09; P = 0.0026)]; 
      reductions in mean fasting plasma glucose levels were also greater with 
      liraglutide [estimated mean difference -5.47 mg/dL (-0.30 mmol/L; 95% CI: -10.83, 
      -0.10; P = 0.0458)]. CONCLUSIONS: Liraglutide was well tolerated and effective as 
      combination therapy with an OAD in Japanese patients with type 2 diabetes.
FAU - Kaku, Kohei
AU  - Kaku K
AD  - Department of Internal Medicine Kawasaki Medical School Okayama Japan.
FAU - Kiyosue, Arihiro
AU  - Kiyosue A
AD  - Tokyo-Eki Center-building Clinic Tokyo Japan.
FAU - Ono, Yuri
AU  - Ono Y
AD  - Yuri Ono Clinic Hokkaido Japan.
FAU - Shiraiwa, Toshihiko
AU  - Shiraiwa T
AD  - Shiraiwa Medical Clinic Osaka Japan.
FAU - Kaneko, Shizuka
AU  - Kaneko S
AD  - Takatsuki Red Cross Hospital Osaka Japan.
FAU - Nishijima, Keiji
AU  - Nishijima K
AD  - Medical & Scientific Affairs Department Novo Nordisk Pharma Ltd Tokyo Japan.
FAU - Bosch-Traberg, Heidrun
AU  - Bosch-Traberg H
AD  - Medical and Science GLP-1 Novo Nordisk A/S Soborg Denmark.
FAU - Seino, Yutaka
AU  - Seino Y
AD  - Kansai Electric Power Hospital Osaka Japan.
LA  - eng
SI  - ClinicalTrials.gov/NCT01512108
PT  - Journal Article
PT  - Multicenter Study
PT  - Randomized Controlled Trial
PT  - Research Support, Non-U.S. Gov't
DEP - 20150714
PL  - Japan
TA  - J Diabetes Investig
JT  - Journal of diabetes investigation
JID - 101520702
RN  - 0 (Hypoglycemic Agents)
RN  - 839I73S42A (Liraglutide)
RN  - 9100L32L2N (Metformin)
SB  - IM
EIN - J Diabetes Investig. 2016 Mar;7(2):279. PMID: 27042283
MH  - Administration, Oral
MH  - Aged
MH  - *Asian People
MH  - Diabetes Mellitus, Type 2/diagnosis/*drug therapy/*epidemiology
MH  - Drug Therapy, Combination
MH  - Female
MH  - Humans
MH  - Hypoglycemic Agents/*administration & dosage
MH  - Japan/epidemiology
MH  - Liraglutide/*administration & dosage
MH  - Male
MH  - Metformin/administration & dosage
MH  - Middle Aged
MH  - Treatment Outcome
PMC - PMC4718097
OTO - NOTNLM
OT  - Liraglutide
OT  - Oral antidiabetic drug
OT  - Type 2 diabetes mellitus
EDAT- 2016/01/28 06:00
MHDA- 2016/10/25 06:00
PMCR- 2016/01/01
CRDT- 2016/01/28 06:00
PHST- 2014/12/15 00:00 [received]
PHST- 2015/04/07 00:00 [revised]
PHST- 2015/04/20 00:00 [accepted]
PHST- 2016/01/28 06:00 [entrez]
PHST- 2016/01/28 06:00 [pubmed]
PHST- 2016/10/25 06:00 [medline]
PHST- 2016/01/01 00:00 [pmc-release]
AID - JDI12367 [pii]
AID - 10.1111/jdi.12367 [doi]
PST - ppublish
SO  - J Diabetes Investig. 2016 Jan;7(1):76-84. doi: 10.1111/jdi.12367. Epub 2015 Jul 
      14.