PMID- 29079379
OWN - NLM
STAT- MEDLINE
DCOM- 20180524
LR  - 20221207
IS  - 1872-8227 (Electronic)
IS  - 0168-8227 (Linking)
VI  - 138
DP  - 2018 Apr
TI  - A randomized, double-blind trial evaluating the efficacy and safety of 
      monotherapy with the once-weekly dipeptidyl peptidase-4 inhibitor omarigliptin in 
      people with type 2 diabetes.
PG  - 253-261
LID - S0168-8227(17)30488-6 [pii]
LID - 10.1016/j.diabres.2017.10.018 [doi]
AB  - AIMS: To assess the efficacy and safety of once-weekly omarigliptin as 
      monotherapy in people with type 2 diabetes mellitus (T2DM). METHODS: People with 
      T2DM not on glucose-lowering medications, or who were washed off monotherapy or 
      low-dose dual therapy, were randomized double-blind to omarigliptin 25 mg (n=165) 
      or matching omarigliptin placebo (n=164) for 24 weeks, followed by a 30-week 
      period to assess continuing efficacy and safety longer-term of omarigliptin 
      during which metformin was added to the placebo group and metformin placebo to 
      the omarigliptin group. RESULTS: From a mean baseline HbA1c of 8.0-8.1%, the 
      least squares mean (95% CI) change from baseline in HbA1c at week 24 (primary 
      endpoint) was -0.49% (-0.73, -0.24) in the omarigliptin group and -0.10% (-0.34, 
      0.14) in the placebo group, for a between-group difference of -0.39% (-0.59, 
      -0.19) (p<.001). Protocol deviation in use of metformin by 38 of 252 (15%) people 
      whose samples were available for evaluation probably attenuated glycemic efficacy 
      results, as suggested by the LS mean difference -0.53% (-0.75, -0.32) after 
      censoring of such participants. At 24 and 54 weeks, the incidences of adverse 
      events (AEs) were similar in the omarigliptin and placebo groups. During 54 weeks 
      there were no AEs of symptomatic hypoglycemia in the omarigliptin group and 5 AEs 
      in the placebo group. Over 54 weeks, a majority of the omarigliptin treatment had 
      a persistent reduction in HbA1c, remaining rescue-free. CONCLUSIONS: In people 
      with T2DM, omarigliptin monotherapy improved glycemic control over 54 weeks and 
      was generally well tolerated with a low risk of hypoglycemia. ClinicalTrials.gov 
      Identifier: NCT01717313. EudraCT Number: 2012-003626-24.
CI  - Copyright (c) 2017 Merck Sharp & Dohme Corp.,, The Authors. Published by Elsevier 
      B.V. All rights reserved.
FAU - Home, Philip
AU  - Home P
AD  - Newcastle University, Newcastle upon Tyne, UK.
FAU - Shankar, R Ravi
AU  - Shankar RR
AD  - Merck & Co., Inc., Kenilworth, NJ, USA. Electronic address: 
      ravi.shankar3@merck.com.
FAU - Gantz, Ira
AU  - Gantz I
AD  - Merck & Co., Inc., Kenilworth, NJ, USA.
FAU - Iredale, Carol
AU  - Iredale C
AD  - Merck & Co., Inc., Kenilworth, NJ, USA.
FAU - O'Neill, Edward A
AU  - O'Neill EA
AD  - Merck & Co., Inc., Kenilworth, NJ, USA.
FAU - Jain, Lokesh
AU  - Jain L
AD  - Merck & Co., Inc., Kenilworth, NJ, USA.
FAU - Pong, Annpey
AU  - Pong A
AD  - Merck & Co., Inc., Kenilworth, NJ, USA.
FAU - Suryawanshi, Shailaja
AU  - Suryawanshi S
AD  - Merck & Co., Inc., Kenilworth, NJ, USA.
FAU - Engel, Samuel S
AU  - Engel SS
AD  - Merck & Co., Inc., Kenilworth, NJ, USA.
FAU - Kaufman, Keith D
AU  - Kaufman KD
AD  - Merck & Co., Inc., Kenilworth, NJ, USA.
FAU - Lai, Eseng
AU  - Lai E
AD  - Merck & Co., Inc., Kenilworth, NJ, USA.
LA  - eng
SI  - ClinicalTrials.gov/NCT01717313
PT  - Journal Article
PT  - Multicenter Study
PT  - Randomized Controlled Trial
DEP - 20171024
PL  - Ireland
TA  - Diabetes Res Clin Pract
JT  - Diabetes research and clinical practice
JID - 8508335
RN  - 0 
      (2-(2,5-difluorophenyl)-5-(2-(methylsulfonyl)-2,6-dihydropyrrolo(3,4-c)pyrazol-5(4H)-yl)tetrahydro-2H-pyran-3-amine)
RN  - 0 (Blood Glucose)
RN  - 0 (Dipeptidyl-Peptidase IV Inhibitors)
RN  - 0 (Glycated Hemoglobin A)
RN  - 0 (Heterocyclic Compounds, 2-Ring)
RN  - 0 (Hypoglycemic Agents)
RN  - 0 (Pyrans)
SB  - IM
MH  - Aged
MH  - Blood Glucose/drug effects/metabolism
MH  - Diabetes Mellitus, Type 2/drug therapy
MH  - Dipeptidyl-Peptidase IV Inhibitors/*administration & dosage/*adverse effects
MH  - Double-Blind Method
MH  - Drug Administration Schedule
MH  - Female
MH  - Glycated Hemoglobin/drug effects
MH  - Heterocyclic Compounds, 2-Ring/*administration & dosage/*adverse effects
MH  - Humans
MH  - Hypoglycemia/chemically induced/epidemiology
MH  - Hypoglycemic Agents/administration & dosage/adverse effects/therapeutic use
MH  - Male
MH  - Middle Aged
MH  - Pyrans/*administration & dosage/*adverse effects
MH  - Treatment Outcome
OTO - NOTNLM
OT  - DPP-4 inhibitor
OT  - Incretin therapy
OT  - Omarigliptin
OT  - Patient non-adherence
OT  - Prohibited medication
OT  - Protocol violation
EDAT- 2017/10/29 06:00
MHDA- 2018/05/25 06:00
CRDT- 2017/10/29 06:00
PHST- 2017/03/24 00:00 [received]
PHST- 2017/09/27 00:00 [revised]
PHST- 2017/10/18 00:00 [accepted]
PHST- 2017/10/29 06:00 [pubmed]
PHST- 2018/05/25 06:00 [medline]
PHST- 2017/10/29 06:00 [entrez]
AID - S0168-8227(17)30488-6 [pii]
AID - 10.1016/j.diabres.2017.10.018 [doi]
PST - ppublish
SO  - Diabetes Res Clin Pract. 2018 Apr;138:253-261. doi: 
      10.1016/j.diabres.2017.10.018. Epub 2017 Oct 24.