PMID- 23248197
OWN - NLM
STAT- MEDLINE
DCOM- 20131202
LR  - 20220311
IS  - 1935-5548 (Electronic)
IS  - 0149-5992 (Print)
IS  - 0149-5992 (Linking)
VI  - 36
IP  - 5
DP  - 2013 May
TI  - Efficacy and safety of sitagliptin versus glipizide in patients with type 2 
      diabetes and moderate-to-severe chronic renal insufficiency.
PG  - 1067-73
LID - 10.2337/dc12-1365 [doi]
AB  - OBJECTIVE: Patients with type 2 diabetes mellitus (T2DM) and chronic kidney 
      disease have an increased risk of micro- and macrovascular disease, but limited 
      options for antihyperglycemic therapy. We compared the efficacy and safety of 
      sitagliptin with glipizide in patients with T2DM and moderate-to-severe chronic 
      renal insufficiency and inadequate glycemic control. RESEARCH DESIGN AND METHODS: 
      Patients (n = 426) were randomized 1:1 to sitagliptin (50 mg every day [q.d.] for 
      moderate renal insufficiency and 25 mg q.d. for severe renal insufficiency) or 
      glipizide (2.5 mg q.d., adjusted based on glycemic control to a 10-mg twice a day 
      maximum dose). Randomization was stratified by: 1) renal status (moderate or 
      severe renal insufficiency); 2) history of cardiovascular disease; and 3) history 
      of heart failure. RESULTS: At week 54, treatment with sitagliptin was noninferior 
      to treatment with glipizide in A1C change from baseline (-0.8 vs. -0.6%; 
      between-group difference -0.11%; 95% CI -0.29 to 0.06) because the upper bound of 
      the 95% CI was less than the prespecified noninferiority margin of 0.4%. There 
      was a lower incidence of symptomatic hypoglycemia adverse events (AEs) with 
      sitagliptin versus glipizide (6.2 and 17.0%, respectively; P = 0.001) and a 
      decrease in body weight with sitagliptin (-0.6 kg) versus an increase (1.2 kg) 
      with glipizide (difference, -1.8 kg; P < 0.001). The incidence of 
      gastrointestinal AEs was low with both treatments. CONCLUSIONS: In patients with 
      T2DM and chronic renal insufficiency, sitagliptin and glipizide provided similar 
      A1C-lowering efficacy. Sitagliptin was generally well-tolerated, with a lower 
      risk of hypoglycemia and weight loss versus weight gain, relative to glipizide.
FAU - Arjona Ferreira, Juan Camilo
AU  - Arjona Ferreira JC
AD  - Merck Sharp & Dohme Corp., Whitehouse Station, NJ, USA. juan_arjona@merck.com
FAU - Marre, Michel
AU  - Marre M
FAU - Barzilai, Nir
AU  - Barzilai N
FAU - Guo, Hua
AU  - Guo H
FAU - Golm, Gregory T
AU  - Golm GT
FAU - Sisk, Christine McCrary
AU  - Sisk CM
FAU - Kaufman, Keith D
AU  - Kaufman KD
FAU - Goldstein, Barry J
AU  - Goldstein BJ
LA  - eng
PT  - Journal Article
PT  - Randomized Controlled Trial
PT  - Research Support, Non-U.S. Gov't
DEP - 20121217
PL  - United States
TA  - Diabetes Care
JT  - Diabetes care
JID - 7805975
RN  - 0 (Hypoglycemic Agents)
RN  - 0 (Pyrazines)
RN  - 0 (Triazoles)
RN  - TS63EW8X6F (Sitagliptin Phosphate)
RN  - X7WDT95N5C (Glipizide)
SB  - IM
MH  - Body Weight/drug effects
MH  - Diabetes Mellitus, Type 2/*drug therapy
MH  - Female
MH  - Glipizide/*adverse effects/*therapeutic use
MH  - Humans
MH  - Hypoglycemic Agents/*adverse effects/*therapeutic use
MH  - Male
MH  - Pyrazines/*adverse effects/*therapeutic use
MH  - Renal Insufficiency, Chronic/*blood
MH  - Sitagliptin Phosphate
MH  - Triazoles/*adverse effects/*therapeutic use
PMC - PMC3631833
EDAT- 2012/12/19 06:00
MHDA- 2013/12/16 06:00
PMCR- 2014/05/01
CRDT- 2012/12/19 06:00
PHST- 2012/12/19 06:00 [entrez]
PHST- 2012/12/19 06:00 [pubmed]
PHST- 2013/12/16 06:00 [medline]
PHST- 2014/05/01 00:00 [pmc-release]
AID - dc12-1365 [pii]
AID - 1365 [pii]
AID - 10.2337/dc12-1365 [doi]
PST - ppublish
SO  - Diabetes Care. 2013 May;36(5):1067-73. doi: 10.2337/dc12-1365. Epub 2012 Dec 17.