PMID- 23881432
OWN - NLM
STAT- PubMed-not-MEDLINE
DCOM- 20131218
LR  - 20211021
IS  - 1869-6953 (Print)
IS  - 1869-6961 (Electronic)
IS  - 1869-6961 (Linking)
VI  - 4
IP  - 2
DP  - 2013 Dec
TI  - Adding Saxagliptin to Metformin Extended Release (XR) or Uptitration of Metformin 
      XR: Efficacy on Daily Glucose Measures.
PG  - 269-83
LID - 10.1007/s13300-013-0028-9 [doi]
AB  - INTRODUCTION: Saxagliptin added to metformin extended release (XR) and uptitrated 
      metformin XR were evaluated for their impact on daily glucose measurements and 
      their tolerability in patients with type 2 diabetes mellitus (T2DM) inadequately 
      controlled with metformin monotherapy. METHODS: Patients aged 18-78 years on 
      metformin 850-1,500 mg with glycated hemoglobin (HbA1c) 7.5-11.5% at screening 
      were eligible for this double-blind, active-controlled study. Patients were 
      stabilized on metformin XR 1,500 mg before randomization. Patients with HbA1c 
      7-11% and fasting plasma glucose (FPG) >/=126 mg/dL after a 4- 8-week lead-in 
      period were randomly assigned to saxagliptin 5 mg + metformin XR 1,500 mg or 
      metformin XR 500 mg + metformin XR 1,500 mg (uptitrated metformin XR). The 
      primary end point was change from baseline to week 4 in 24-h mean weighted 
      glucose (MWG). Secondary end points were changes from baseline to week 4 in 2-h 
      postprandial glucose (PPG) and FPG. RESULTS: At week 4, the adjusted mean +/- SE 
      change from baseline in 24-h MWG was -19.0 +/- 5.7 mg/dL (95% CI -30.3 to -7.6) for 
      saxagliptin + metformin XR and -8.2 +/- 6.0 mg/dL (95% CI -20.0 to 3.7) for 
      uptitrated metformin XR. Mean changes from baseline in 2-h PPG and FPG were 
      numerically greater with saxagliptin + metformin XR versus uptitrated metformin 
      XR. The incidence of adverse events was lower with saxagliptin + metformin XR 
      (17.4%) versus uptitrated metformin XR (31.9%) mainly due to differences in 
      gastrointestinal adverse event incidence (2.2% vs 10.6%, respectively). There 
      were no reports of confirmed hypoglycemia in either group. CONCLUSION: In this 
      4-week study in patients with T2DM inadequately controlled with metformin 
      monotherapy, saxagliptin added to metformin XR demonstrated a trend for 
      improvement in measures of daily glycemic control, with fewer gastrointestinal 
      adverse events, compared with uptitrated metformin.
FAU - Neutel, Joel M
AU  - Neutel JM
AD  - Orange County Research Center, 14351 Myford Rd, Suite B, Tustin, CA, 93780, USA, 
      jmneutel@aol.com.
FAU - Zhao, Cathy
AU  - Zhao C
FAU - Karyekar, Chetan S
AU  - Karyekar CS
LA  - eng
PT  - Journal Article
DEP - 20130724
PL  - United States
TA  - Diabetes Ther
JT  - Diabetes therapy : research, treatment and education of diabetes and related 
      disorders
JID - 101539025
PMC - PMC3889315
EDAT- 2013/07/25 06:00
MHDA- 2013/07/25 06:01
PMCR- 2013/07/24
CRDT- 2013/07/25 06:00
PHST- 2013/03/01 00:00 [received]
PHST- 2013/07/25 06:00 [entrez]
PHST- 2013/07/25 06:00 [pubmed]
PHST- 2013/07/25 06:01 [medline]
PHST- 2013/07/24 00:00 [pmc-release]
AID - 28 [pii]
AID - 10.1007/s13300-013-0028-9 [doi]
PST - ppublish
SO  - Diabetes Ther. 2013 Dec;4(2):269-83. doi: 10.1007/s13300-013-0028-9. Epub 2013 
      Jul 24.