PMID- 30019498
OWN - NLM
STAT- MEDLINE
DCOM- 20190531
LR  - 20221207
IS  - 1463-1326 (Electronic)
IS  - 1462-8902 (Print)
IS  - 1462-8902 (Linking)
VI  - 20
IP  - 12
DP  - 2018 Dec
TI  - A randomized clinical trial of the efficacy and safety of sitagliptin compared 
      with dapagliflozin in patients with type 2 diabetes mellitus and mild renal 
      insufficiency: The CompoSIT-R study.
PG  - 2876-2884
LID - 10.1111/dom.13473 [doi]
AB  - AIM: To compare the efficacy and safety of the dipeptidyl peptidase-4 inhibitor 
      sitagliptin with the sodium-glucose transporter-2 inhibitor dapagliflozin in 
      patients with type 2 diabetes and mild renal insufficiency. MATERIALS AND 
      METHODS: Patients with HbA1c >/=7.0 to </=9.5% (>/=53 to </=80 mmol/mol) and estimated 
      glomerular filtration rate >/=60 to <90 mL/min/1.73m(2) on metformin 
      (>/=1500 mg/d) +/- sulfonylurea were randomized to sitagliptin 100 mg (n = 307) or 
      dapagliflozin 5 mg titrated to 10 mg (n = 306) once daily for 24 weeks. A 
      longitudinal data analysis model was used to test the primary hypothesis that 
      sitagliptin is non-inferior to dapagliflozin in reducing HbA1c at Week 24, with 
      superiority to be tested if non-inferiority is met. ClinicalTrials.gov 
      NCT02532855. RESULTS: Baseline mean HbA1c (% [mmol/mol]) was 7.7 (60.9) and 7.8 
      (61.2), and mean eGFR (mL/min/1.73m(2) ) was 79.4 and 76.9 for the sitagliptin 
      and dapagliflozin groups, respectively. After 24 weeks, the between-group 
      difference in least squares mean (95% CI) changes from baseline in HbA1c was 
      -0.15% (-0.26, -0.04) (-1.67 mmol/mol [-2.86, -0.48]), P = 0.006, meeting the 
      prespecified criteria for declaring both non-inferiority and superiority of 
      sitagliptin versus dapagliflozin. The HbA1c goal of <7% (<53 mmol/mol) was met by 
      43% (sitagliptin) and 27% (dapagliflozin) of patients. No meaningful 
      between-group difference was observed in a pre-specified analysis of 2-hour 
      incremental postprandial glucose excursion. A review of adverse events (AEs) was 
      notable for a lower incidence of drug-related AEs with sitagliptin compared with 
      dapagliflozin. CONCLUSIONS: In patients with type 2 diabetes, mild renal 
      insufficiency and inadequate glycaemic control on metformin +/- sulfonylurea, 
      sitagliptin treatment resulted in greater improvement in glycaemic control 
      compared with dapagliflozin and was generally well tolerated.
CI  - (c) 2018 The Authors. Diabetes, Obesity and Metabolism published by John Wiley & 
      Sons Ltd.
FAU - Scott, Russell
AU  - Scott R
AD  - Lipid and Diabetes Research Group, Christchurch School of Medicine, Christchurch, 
      New Zealand.
FAU - Morgan, Jerry
AU  - Morgan J
AD  - Merck & Co., Inc., Kenilworth, New Jersey.
FAU - Zimmer, Zachary
AU  - Zimmer Z
AD  - Merck & Co., Inc., Kenilworth, New Jersey.
FAU - Lam, Raymond L H
AU  - Lam RLH
AD  - Merck & Co., Inc., Kenilworth, New Jersey.
FAU - O'Neill, Edward A
AU  - O'Neill EA
AD  - Merck & Co., Inc., Kenilworth, New Jersey.
FAU - Kaufman, Keith D
AU  - Kaufman KD
AD  - Merck & Co., Inc., Kenilworth, New Jersey.
FAU - Engel, Samuel S
AU  - Engel SS
AUID- ORCID: 0000-0002-4439-6356
AD  - Merck & Co., Inc., Kenilworth, New Jersey.
FAU - Raji, Annaswamy
AU  - Raji A
AUID- ORCID: 0000-0002-2430-8160
AD  - Merck & Co., Inc., Kenilworth, New Jersey.
LA  - eng
SI  - ClinicalTrials.gov/NCT02532855
PT  - Equivalence Trial
PT  - Journal Article
PT  - Multicenter Study
PT  - Randomized Controlled Trial
PT  - Research Support, Non-U.S. Gov't
DEP - 20180816
PL  - England
TA  - Diabetes Obes Metab
JT  - Diabetes, obesity & metabolism
JID - 100883645
RN  - 0 (Benzhydryl Compounds)
RN  - 0 (Blood Glucose)
RN  - 0 (Glucosides)
RN  - 0 (Glycated Hemoglobin A)
RN  - 0 (Hypoglycemic Agents)
RN  - 0 (hemoglobin A1c protein, human)
RN  - 1ULL0QJ8UC (dapagliflozin)
RN  - TS63EW8X6F (Sitagliptin Phosphate)
SB  - IM
MH  - Adult
MH  - Aged
MH  - Benzhydryl Compounds/*therapeutic use
MH  - Blood Glucose/drug effects
MH  - Diabetes Mellitus, Type 2/blood/complications/*drug therapy
MH  - Double-Blind Method
MH  - Female
MH  - Glomerular Filtration Rate
MH  - Glucosides/*therapeutic use
MH  - Glycated Hemoglobin/drug effects
MH  - Humans
MH  - Hypoglycemic Agents/*therapeutic use
MH  - Kidney/physiopathology
MH  - Least-Squares Analysis
MH  - Male
MH  - Middle Aged
MH  - Postprandial Period/drug effects
MH  - Renal Insufficiency/*etiology/physiopathology
MH  - Sitagliptin Phosphate/*therapeutic use
MH  - Treatment Outcome
PMC - PMC6283039
OTO - NOTNLM
OT  - clinical trial
OT  - dapagliflozin
OT  - sitagliptin
OT  - type 2 diabetes
COIS- J. M., Z. Z., R. L. H. L., E. A. O., K. D. K., S. S. E. and A. R. are employees 
      of Merck Sharp & Dohme Corp., a subsidiary of Merck & Co., Inc., Kenilworth, NJ, 
      and may hold stock and/or stock options in the company. R. S. has no conflicts of 
      interest to declare.
EDAT- 2018/07/19 06:00
MHDA- 2019/06/01 06:00
PMCR- 2018/12/06
CRDT- 2018/07/19 06:00
PHST- 2018/05/31 00:00 [received]
PHST- 2018/07/05 00:00 [revised]
PHST- 2018/07/14 00:00 [accepted]
PHST- 2018/07/19 06:00 [pubmed]
PHST- 2019/06/01 06:00 [medline]
PHST- 2018/07/19 06:00 [entrez]
PHST- 2018/12/06 00:00 [pmc-release]
AID - DOM13473 [pii]
AID - 10.1111/dom.13473 [doi]
PST - ppublish
SO  - Diabetes Obes Metab. 2018 Dec;20(12):2876-2884. doi: 10.1111/dom.13473. Epub 2018 
      Aug 16.