PMID- 22192246
OWN - NLM
STAT- MEDLINE
DCOM- 20120614
LR  - 20221207
IS  - 1463-1326 (Electronic)
IS  - 1462-8902 (Linking)
VI  - 14
IP  - 4
DP  - 2012 Apr
TI  - Adding saxagliptin to extended-release metformin vs. uptitrating metformin 
      dosage.
PG  - 365-71
LID - 10.1111/j.1463-1326.2011.01553.x [doi]
AB  - AIM: To investigate whether patients taking metformin for type 2 diabetes 
      mellitus (T2DM) have improved glycaemic control without compromising tolerability 
      by adding an agent with a complementary mechanism of action vs. uptitrating 
      metformin. METHODS: Adults with T2DM and glycated haemoglobin (HbA1c) between 7.0 
      and 10.5% receiving metformin extended release (XR) 1500 mg/day for >/=8 weeks were 
      randomized to receive saxagliptin 5 mg added to metformin XR 1500 mg (n = 138) or 
      metformin XR uptitrated to 2000 mg/day (n = 144). Endpoints were change from 
      baseline to week 18 in HbA1c (primary), 120-min postprandial glucose (PPG), 
      fasting plasma glucose (FPG) and the proportion of patients achieving HbA1c <7%. 
      RESULTS: At week 18, the adjusted mean reduction from baseline HbA1c was -0.88% 
      for saxagliptin + metformin XR and -0.35% for uptitrated metformin XR 
      (difference, -0.52%; p < 0.0001). For 120-min PPG and FPG, differences in 
      adjusted mean change from baseline between saxagliptin + metformin XR and 
      uptitrated metformin XR were -1.3 mmol/l (-23.32 mg/dl) (p = 0.0013) and -0.73 
      mmol/l (-13.18 mg/dl) (p = 0.0030), respectively. More patients achieved HbA1c 
      <7.0% with saxagliptin + metformin XR than with uptitrated metformin XR (37.2 vs. 
      26.1%; p = 0.0459). The proportions of patients experiencing any adverse events 
      (AEs) were generally similar between groups; neither group showed any notable 
      difference in hypoglycaemia or gastrointestinal AEs. CONCLUSION: Adding 
      saxagliptin to metformin XR provided superior glycaemic control compared with 
      uptitrating metformin XR without the emergence of additional safety concerns.
CI  - (c) 2011 Blackwell Publishing Ltd.
FAU - Fonseca, V
AU  - Fonseca V
AD  - Department of Medicine, Tulane University Health Sciences Center, 1430 Tulane 
      Avenue, New Orleans, LA 70112, USA. vfonseca@tulane.edu
FAU - Zhu, T
AU  - Zhu T
FAU - Karyekar, C
AU  - Karyekar C
FAU - Hirshberg, B
AU  - Hirshberg B
LA  - eng
SI  - ClinicalTrials.gov/NCT00960076
PT  - Clinical Trial, Phase III
PT  - Journal Article
PT  - Multicenter Study
PT  - Randomized Controlled Trial
PT  - Research Support, Non-U.S. Gov't
DEP - 20120118
PL  - England
TA  - Diabetes Obes Metab
JT  - Diabetes, obesity & metabolism
JID - 100883645
RN  - 0 (Blood Glucose)
RN  - 0 (Delayed-Action Preparations)
RN  - 0 (Dipeptides)
RN  - 0 (Dipeptidyl-Peptidase IV Inhibitors)
RN  - 0 (Glycated Hemoglobin A)
RN  - 9100L32L2N (Metformin)
RN  - 9GB927LAJW (saxagliptin)
RN  - PJY633525U (Adamantane)
SB  - IM
MH  - Adamantane/administration & dosage/*analogs & derivatives/pharmacology
MH  - Blood Glucose/*drug effects/metabolism
MH  - Delayed-Action Preparations
MH  - Diabetes Mellitus, Type 2/blood/*drug therapy
MH  - Dipeptides/*administration & dosage/pharmacology
MH  - Dipeptidyl-Peptidase IV Inhibitors/*administration & dosage/pharmacology
MH  - Double-Blind Method
MH  - Drug Administration Schedule
MH  - Drug Therapy, Combination
MH  - Fasting
MH  - Female
MH  - Glycated Hemoglobin/metabolism
MH  - Humans
MH  - Latin America
MH  - Male
MH  - Maximum Tolerated Dose
MH  - Metformin/*administration & dosage/pharmacology
MH  - Middle Aged
MH  - Postprandial Period/drug effects
MH  - Treatment Outcome
MH  - United States
EDAT- 2011/12/24 06:00
MHDA- 2012/06/15 06:00
CRDT- 2011/12/24 06:00
PHST- 2011/12/24 06:00 [entrez]
PHST- 2011/12/24 06:00 [pubmed]
PHST- 2012/06/15 06:00 [medline]
AID - 10.1111/j.1463-1326.2011.01553.x [doi]
PST - ppublish
SO  - Diabetes Obes Metab. 2012 Apr;14(4):365-71. doi: 
      10.1111/j.1463-1326.2011.01553.x. Epub 2012 Jan 18.