PMID- 28589493
OWN - NLM
STAT- PubMed-not-MEDLINE
LR  - 20231112
IS  - 1869-6953 (Print)
IS  - 1869-6961 (Electronic)
IS  - 1869-6961 (Linking)
VI  - 8
IP  - 4
DP  - 2017 Aug
TI  - A Randomized, Placebo-Controlled Trial Evaluating the Safety and Efficacy of 
      Adding Omarigliptin to Antihyperglycemic Therapies in Japanese Patients with Type 
      2 Diabetes and Inadequate Glycemic Control.
PG  - 793-810
LID - 10.1007/s13300-017-0270-7 [doi]
AB  - INTRODUCTION: Daily dipeptidyl peptidase-4 (DPP-4) inhibitors are commonly used 
      with other orally administered antihyperglycemic agents (AHA), as combination 
      therapy, to treat Japanese patients with type 2 diabetes. When combination 
      therapy is indicated, use of a once-weekly (q.w.) orally administered DPP-4 
      inhibitor might be an appropriate therapeutic option for some patients. METHODS: 
      A 52-week trial was conducted to assess the safety and tolerability (primary 
      objectives) and glycemic efficacy (secondary objectives) of the q.w. DPP-4 
      inhibitor omarigliptin as add-on therapy to five different classes of orally 
      administered AHA [sulfonylurea (SU), glinide (GL), biguanide (BG), 
      thiazolidinedione (TZD), or alpha-glucosidase inhibitor (AGI)] commonly used in Japan 
      and having different mechanisms of drug action from DPP-4 inhibitors. The trial 
      consisted of an initial 24-week double-blind, placebo-controlled period during 
      which patients (stratified by background AHA) were randomized to omarigliptin 
      25 mg q.w. or placebo, followed by a 28-week open-label period during which 
      patients on placebo were switched to omarigliptin. RESULTS: After 24 weeks, the 
      percentages of patients with adverse events (AEs), serious AEs, drug-related AEs, 
      AEs of symptomatic hypoglycemia, or who discontinued from trial medication 
      because of an AE were generally similar in the omarigliptin and placebo groups, 
      in all background AHA strata and in the overall population. From a mean baseline 
      HbA1c of approximately 8.0%, the placebo-adjusted least-squares mean changes from 
      baseline ranged from -0.80% (AGI stratum) to -1.16% (TZD stratum); p < 0.001 for 
      all background AHA strata. During the open-label period, no safety signals 
      emerged with longer-term treatment. At week 52, the change from baseline in HbA1c 
      in the omarigliptin/omarigliptin group was similar to that of the 
      placebo/omarigliptin group. CONCLUSIONS: Addition of once-weekly omarigliptin to 
      AHA therapy with an SU, GL, BG, TZD, or AGI for up to 52 weeks was generally safe 
      and well tolerated, and provided persistent efficacy. CLINICAL TRIAL 
      REGISTRATION: ClinicalTrials.gov: NCT01697592. FUNDING: MSD K.K., a subsidiary of 
      Merck & Co., Inc., Kenilworth, NJ, USA.
FAU - Gantz, Ira
AU  - Gantz I
AUID- ORCID: 0000-0002-6565-7113
AD  - Merck & Co., Inc., Kenilworth, NJ, USA. ira.gantz@merck.com.
FAU - Okamoto, Taro
AU  - Okamoto T
AD  - MSD K.K., Tokyo, Japan.
FAU - Ito, Yuka
AU  - Ito Y
AD  - MSD K.K., Tokyo, Japan.
FAU - Sato, Asako
AU  - Sato A
AD  - MSD K.K., Tokyo, Japan.
FAU - Okuyama, Kotoba
AU  - Okuyama K
AD  - MSD K.K., Tokyo, Japan.
FAU - O'Neill, Edward A
AU  - O'Neill EA
AD  - Merck & Co., Inc., Kenilworth, NJ, USA.
FAU - Engel, Samuel S
AU  - Engel SS
AD  - Merck & Co., Inc., Kenilworth, NJ, USA.
FAU - Lai, Eseng
AU  - Lai E
AD  - Merck & Co., Inc., Kenilworth, NJ, USA.
CN  - Omarigliptin Study 015 Group
LA  - eng
SI  - ClinicalTrials.gov/NCT01697592
PT  - Journal Article
DEP - 20170606
PL  - United States
TA  - Diabetes Ther
JT  - Diabetes therapy : research, treatment and education of diabetes and related 
      disorders
JID - 101539025
PMC - PMC5544607
OTO - NOTNLM
OT  - Biguanide
OT  - DPP-4
OT  - Dipeptidyl peptidase-4
OT  - Glinide
OT  - Incretins
OT  - MK-3102
OT  - Oral antihyperglycemic agent
OT  - Sulfonylurea
OT  - Thiazolidinedione
OT  - alpha-Glucosidase inhibitor
EDAT- 2017/06/08 06:00
MHDA- 2017/06/08 06:01
PMCR- 2017/06/06
CRDT- 2017/06/08 06:00
PHST- 2017/03/28 00:00 [received]
PHST- 2017/06/08 06:00 [pubmed]
PHST- 2017/06/08 06:01 [medline]
PHST- 2017/06/08 06:00 [entrez]
PHST- 2017/06/06 00:00 [pmc-release]
AID - 10.1007/s13300-017-0270-7 [pii]
AID - 270 [pii]
AID - 10.1007/s13300-017-0270-7 [doi]
PST - ppublish
SO  - Diabetes Ther. 2017 Aug;8(4):793-810. doi: 10.1007/s13300-017-0270-7. Epub 2017 
      Jun 6.