PMID- 21977965
OWN - NLM
STAT- MEDLINE
DCOM- 20120110
LR  - 20221207
IS  - 1742-1241 (Electronic)
IS  - 1368-5031 (Linking)
VI  - 65
IP  - 12
DP  - 2011 Dec
TI  - Long-term treatment with the dipeptidyl peptidase-4 inhibitor saxagliptin in 
      patients with type 2 diabetes mellitus and renal impairment: a randomised 
      controlled 52-week efficacy and safety study.
PG  - 1230-9
LID - 10.1111/j.1742-1241.2011.02812.x [doi]
AB  - OBJECTIVE: Therapeutic options are limited for diabetes patients with renal 
      disease. This report presents 52-week results from a study assessing the 
      dipeptidyl peptidase-4 inhibitor saxagliptin in patients with type 2 diabetes 
      mellitus (T2DM) and renal impairment. DESIGN: Double-blind study in patients 
      stratified by baseline renal impairment (moderate, severe or end-stage renal 
      disease [ESRD] on haemodialysis) randomised to saxagliptin 2.5 mg once daily or 
      placebo added to other antidiabetic drugs in use at baseline, including insulin. 
      PATIENTS: A total of 170 adults with glycated haemoglobin (HbA(1c) ) 7-11% and 
      creatinine clearance < 50 ml/min or ESRD were randomised and treated. 
      MEASUREMENTS: Absolute changes in HbA(1c) and fasting plasma glucose (FPG) from 
      baseline to week 52 were evaluated using analysis of covariance (ANCOVA) with 
      last observation carried forward. Repeated-measures analyses were also performed. 
      RESULTS: Adjusted mean decrease in HbA(1c) was greater with saxagliptin than 
      placebo (difference, -0.73%, p < 0.001 [ANCOVA]). Reductions in adjusted mean 
      HbA(1c) were numerically greater with saxagliptin than placebo in patients with 
      renal impairment rated as moderate (-0.94% vs. 0.19% respectively) or severe 
      (-0.81% vs. -0.49%), but similar to placebo for those with ESRD (-1.13% vs. 
      -0.99%). Reductions in adjusted mean FPG were numerically greater with 
      saxagliptin in patients with moderate or severe renal impairment. Saxagliptin was 
      generally well tolerated; similar proportions of patients in the saxagliptin and 
      placebo groups reported hypoglycaemic events (28% and 29% respectively). 
      CONCLUSIONS: Saxagliptin 2.5 mg once daily offers sustained efficacy and good 
      tolerability for patients with T2DM and renal impairment.
CI  - (c) 2011 Blackwell Publishing Ltd.
FAU - Nowicki, M
AU  - Nowicki M
AD  - Medical University, Lodz, Poland.
FAU - Rychlik, I
AU  - Rychlik I
FAU - Haller, H
AU  - Haller H
FAU - Warren, M
AU  - Warren M
FAU - Suchower, L
AU  - Suchower L
FAU - Gause-Nilsson, I
AU  - Gause-Nilsson I
FAU - Schutzer, K-M
AU  - Schutzer KM
LA  - eng
PT  - Journal Article
PT  - Randomized Controlled Trial
PT  - Research Support, Non-U.S. Gov't
DEP - 20111007
PL  - India
TA  - Int J Clin Pract
JT  - International journal of clinical practice
JID - 9712381
RN  - 0 (Blood Glucose)
RN  - 0 (Dipeptides)
RN  - 0 (Glycated Hemoglobin A)
RN  - 0 (Hypoglycemic Agents)
RN  - 9GB927LAJW (saxagliptin)
RN  - PJY633525U (Adamantane)
SB  - IM
MH  - Adamantane/administration & dosage/adverse effects/*analogs & derivatives
MH  - Aged
MH  - Analysis of Variance
MH  - Blood Glucose/metabolism
MH  - Diabetes Mellitus, Type 2/blood/*drug therapy
MH  - Diabetic Nephropathies/blood/*drug therapy
MH  - Dipeptides/*administration & dosage/adverse effects
MH  - Double-Blind Method
MH  - Fasting/blood
MH  - Glycated Hemoglobin/metabolism
MH  - Humans
MH  - Hypoglycemia/chemically induced
MH  - Hypoglycemic Agents/*administration & dosage/adverse effects
MH  - Kidney Failure, Chronic/blood/*drug therapy
MH  - Treatment Outcome
EDAT- 2011/10/08 06:00
MHDA- 2012/01/11 06:00
CRDT- 2011/10/08 06:00
PHST- 2011/10/08 06:00 [entrez]
PHST- 2011/10/08 06:00 [pubmed]
PHST- 2012/01/11 06:00 [medline]
AID - 10.1111/j.1742-1241.2011.02812.x [doi]
PST - ppublish
SO  - Int J Clin Pract. 2011 Dec;65(12):1230-9. doi: 10.1111/j.1742-1241.2011.02812.x. 
      Epub 2011 Oct 7.