PMID- 18284434
OWN - NLM
STAT- MEDLINE
DCOM- 20090820
LR  - 20221207
IS  - 1463-1326 (Electronic)
IS  - 1462-8902 (Linking)
VI  - 10
IP  - 11
DP  - 2008 Nov
TI  - Effects of vildagliptin on glucose control in patients with type 2 diabetes 
      inadequately controlled with a sulphonylurea.
PG  - 1047-56
LID - 10.1111/j.1463-1326.2008.00859.x [doi]
AB  - AIM: To compare the efficacy and tolerability of vildagliptin vs. placebo in 
      patients with type 2 diabetes mellitus (T2DM) who are inadequately controlled 
      [haemoglobin A(1c) (HbA(1c)) 7.5 to 11%] with prior sulphonylurea (SU) 
      monotherapy. METHODS: This 24-week, multicentre, randomized, double-blind, 
      placebo-controlled study assessed the effects of the dipeptidyl peptidase-4 
      inhibitor vildagliptin (50 mg given once or twice daily) vs. placebo added to 
      glimepiride (4 mg once daily) in 515 patients with T2DM. Adjusted mean changes 
      from baseline to end-point (AMDelta) in HbA(1c), fasting plasma glucose, fasting 
      lipids and body weight were compared by analysis of covariance. RESULTS: The 
      between-group difference (vildagliptin - placebo) in AMDelta HbA(1c) was -0.6 +/- 
      0.1% in patients receiving vildagliptin 50 mg daily and -0.7 +/- 0.1% in those 
      receiving 100 mg daily (p < 0.001 vs. placebo for both). Greater efficacy was 
      seen in patients > or =65 years of age (-0.7 +/- 0.1% and -0.8 +/- 0.2% for 50 
      and 100 mg daily respectively) and in patients with baseline HbA(1c) > 9% (Delta 
      = -1.0 +/- 0.2% and -0.9 +/- 0.2% for 50 and 100 mg daily respectively). Relative 
      to placebo, patients receiving vildagliptin also had improvements in beta-cell 
      function and postprandial glucose, with small changes in fasting lipids and body 
      weight. The incidences of adverse events (AEs) (67.1, 66.3 and 64.2%) and serious 
      AEs (2.9, 2.4 and 5.1%) were similar in patients receiving 50 mg vildagliptin, 
      100 mg vildagliptin or placebo respectively. The incidence of hypoglycaemic 
      events was low but slightly higher in the group receiving vildagliptin 100 mg 
      (3.6%) than in the group receiving vildagliptin 50 mg (1.2%) or placebo (0.6%). 
      CONCLUSIONS: In patients with T2DM inadequately controlled with prior SU 
      monotherapy, addition of vildagliptin (50 or 100 mg daily) to glimepiride (4 mg 
      once daily) improves glycaemic control and is well tolerated. Addition of 
      vildagliptin 50 mg daily to SU monotherapy may be a particularly attractive 
      therapy in elderly patients.
FAU - Garber, A J
AU  - Garber AJ
AD  - Baylor College of Medicine, Houston, TX, USA.
FAU - Foley, J E
AU  - Foley JE
FAU - Banerji, M A
AU  - Banerji MA
FAU - Ebeling, P
AU  - Ebeling P
FAU - Gudbjornsdottir, S
AU  - Gudbjornsdottir S
FAU - Camisasca, R-P
AU  - Camisasca RP
FAU - Couturier, A
AU  - Couturier A
FAU - Baron, M A
AU  - Baron MA
LA  - eng
SI  - ClinicalTrials.gov/NCT00099944
PT  - Journal Article
PT  - Multicenter Study
PT  - Randomized Controlled Trial
PT  - Research Support, Non-U.S. Gov't
DEP - 20080218
PL  - England
TA  - Diabetes Obes Metab
JT  - Diabetes, obesity & metabolism
JID - 100883645
RN  - 0 (Biomarkers)
RN  - 0 (Blood Glucose)
RN  - 0 (Dipeptidyl-Peptidase IV Inhibitors)
RN  - 0 (Glycated Hemoglobin A)
RN  - 0 (Hypoglycemic Agents)
RN  - 0 (Insulin)
RN  - 0 (Lipids)
RN  - 0 (Nitriles)
RN  - 0 (Pyrrolidines)
RN  - 0 (Sulfonylurea Compounds)
RN  - 6KY687524K (glimepiride)
RN  - I6B4B2U96P (Vildagliptin)
RN  - PJY633525U (Adamantane)
SB  - IM
MH  - Adamantane/adverse effects/*analogs & derivatives/therapeutic use
MH  - Aged
MH  - Biomarkers/blood
MH  - Blood Glucose/*analysis
MH  - Body Weight
MH  - Diabetes Mellitus, Type 2/*blood/drug therapy
MH  - Dipeptidyl-Peptidase IV Inhibitors/adverse effects/*therapeutic use
MH  - Double-Blind Method
MH  - Drug Administration Schedule
MH  - Drug Therapy, Combination
MH  - Female
MH  - Glycated Hemoglobin/analysis
MH  - Humans
MH  - Hypoglycemic Agents/adverse effects/*therapeutic use
MH  - Insulin/blood
MH  - Lipids/blood
MH  - Male
MH  - Middle Aged
MH  - Nitriles/adverse effects/*therapeutic use
MH  - Postprandial Period
MH  - Pyrrolidines/adverse effects/*therapeutic use
MH  - Sulfonylurea Compounds/adverse effects/*therapeutic use
MH  - Treatment Outcome
MH  - Vildagliptin
EDAT- 2008/02/21 09:00
MHDA- 2009/08/21 09:00
CRDT- 2008/02/21 09:00
PHST- 2008/02/21 09:00 [pubmed]
PHST- 2009/08/21 09:00 [medline]
PHST- 2008/02/21 09:00 [entrez]
AID - DOM859 [pii]
AID - 10.1111/j.1463-1326.2008.00859.x [doi]
PST - ppublish
SO  - Diabetes Obes Metab. 2008 Nov;10(11):1047-56. doi: 
      10.1111/j.1463-1326.2008.00859.x. Epub 2008 Feb 18.