PMID- 25048383
OWN - NLM
STAT- MEDLINE
DCOM- 20150617
LR  - 20221207
IS  - 1935-5548 (Electronic)
IS  - 0149-5992 (Linking)
VI  - 37
IP  - 10
DP  - 2014 Oct
TI  - Efficacy and safety of the once-weekly GLP-1 receptor agonist albiglutide versus 
      sitagliptin in patients with type 2 diabetes and renal impairment: a randomized 
      phase III study.
PG  - 2723-30
LID - 10.2337/dc13-2855 [doi]
AB  - OBJECTIVE: To evaluate weekly subcutaneous albiglutide versus daily sitagliptin 
      in renally impaired patients with type 2 diabetes and inadequately controlled 
      glycemia on a regimen of diet and exercise and/or oral antihyperglycemic 
      medications. RESEARCH DESIGN AND METHODS: In this phase III, randomized, 
      double-blind, multicenter, 52-week study, the primary study end point was HbA1c 
      change from baseline at week 26 in patients with renal impairment, as assessed 
      with estimated glomerular filtration rate and categorized as mild, moderate, or 
      severe (>/=60 to </=89, >/=30 to </=59, and >/=15 to </=29 mL/min/1.73 m(2), respectively). 
      Secondary end points included fasting plasma glucose (FPG), weight, achievement 
      of treatment targets, hyperglycemic rescue, and safety. RESULTS: Baseline 
      demographics were similar across treatment and renal impairment groups with 
      overall mean age of 63.3 years, BMI of 30.4 kg/m(2), HbA1c of 8.2% (66 mmol/mol), 
      and diabetes disease duration of 11.2 years. HbA1c change from baseline at week 
      26 was significantly greater for albiglutide than sitagliptin (-0.83% vs. -0.52%, 
      P = 0.0003). Decreases in HbA1c, FPG, and weight were seen through week 52. Time 
      to hyperglycemic rescue through week 52 was significantly longer for albiglutide 
      than sitagliptin (P = 0.0017). Results of safety assessments were similar between 
      groups, and most adverse events (AEs) were mild or moderate. The incidences of 
      gastrointestinal AEs for albiglutide and sitagliptin were as follows: overall, 
      31.7%, 25.2%; diarrhea, 10.0%, 6.5%; nausea, 4.8%, 3.3%; and vomiting, 1.6%, 
      1.2%, respectively. CONCLUSIONS: Once-weekly albiglutide therapy in renally 
      impaired patients with type 2 diabetes provided statistically superior glycemic 
      improvement with almost similar tolerability compared with daily sitagliptin 
      therapy.
CI  - (c) 2014 by the American Diabetes Association. Readers may use this article as long 
      as the work is properly cited, the use is educational and not for profit, and the 
      work is not altered.
FAU - Leiter, Lawrence A
AU  - Leiter LA
AD  - Division of Endocrinology and Metabolism, Li Ka Shing Knowledge Institute and 
      Keenan Research Centre for Biomedical Science, St. Michael's Hospital, University 
      of Toronto, Toronto, Ontario, Canada leiterl@smh.ca.
FAU - Carr, Molly C
AU  - Carr MC
AD  - GlaxoSmithKline, King of Prussia, PA.
FAU - Stewart, Murray
AU  - Stewart M
AD  - GlaxoSmithKline, King of Prussia, PA.
FAU - Jones-Leone, Angela
AU  - Jones-Leone A
AD  - GlaxoSmithKline, King of Prussia, PA.
FAU - Scott, Rhona
AU  - Scott R
AD  - GlaxoSmithKline, Uxbridge, Middlesex, U.K.
FAU - Yang, Fred
AU  - Yang F
AD  - GlaxoSmithKline, King of Prussia, PA.
FAU - Handelsman, Yehuda
AU  - Handelsman Y
AD  - Metabolic Institute of America, Tarzana, CA.
LA  - eng
PT  - Clinical Trial, Phase III
PT  - Journal Article
PT  - Multicenter Study
PT  - Randomized Controlled Trial
PT  - Research Support, Non-U.S. Gov't
DEP - 20140721
PL  - United States
TA  - Diabetes Care
JT  - Diabetes care
JID - 7805975
RN  - 0 (Blood Glucose)
RN  - 0 (GLP1R protein, human)
RN  - 0 (Glucagon-Like Peptide-1 Receptor)
RN  - 0 (Glycated Hemoglobin A)
RN  - 0 (Hypoglycemic Agents)
RN  - 0 (Pyrazines)
RN  - 0 (Receptors, Glucagon)
RN  - 0 (Triazoles)
RN  - 5E7U48495E (rGLP-1 protein)
RN  - 89750-14-1 (Glucagon-Like Peptide 1)
RN  - TS63EW8X6F (Sitagliptin Phosphate)
SB  - IM
MH  - Aged
MH  - Blood Glucose/drug effects
MH  - Diabetes Mellitus, Type 2/blood/complications/*drug therapy
MH  - Diabetic Nephropathies/blood/*drug therapy
MH  - Double-Blind Method
MH  - Drug Administration Schedule
MH  - Female
MH  - Glucagon-Like Peptide 1/administration & dosage/adverse effects/*analogs & 
      derivatives
MH  - Glucagon-Like Peptide-1 Receptor
MH  - Glycated Hemoglobin/analysis
MH  - Humans
MH  - Hypoglycemic Agents/*administration & dosage/adverse effects
MH  - Male
MH  - Middle Aged
MH  - Pyrazines/*administration & dosage/adverse effects
MH  - Receptors, Glucagon/*agonists
MH  - Renal Insufficiency/blood/*drug therapy
MH  - Sitagliptin Phosphate
MH  - Treatment Outcome
MH  - Triazoles/*administration & dosage/adverse effects
EDAT- 2014/07/23 06:00
MHDA- 2015/06/18 06:00
CRDT- 2014/07/23 06:00
PHST- 2014/07/23 06:00 [entrez]
PHST- 2014/07/23 06:00 [pubmed]
PHST- 2015/06/18 06:00 [medline]
AID - dc13-2855 [pii]
AID - 10.2337/dc13-2855 [doi]
PST - ppublish
SO  - Diabetes Care. 2014 Oct;37(10):2723-30. doi: 10.2337/dc13-2855. Epub 2014 Jul 21.