PMID- 19125777
OWN - NLM
STAT- MEDLINE
DCOM- 20090805
LR  - 20220311
IS  - 1463-1326 (Electronic)
IS  - 1462-8902 (Linking)
VI  - 11
IP  - 2
DP  - 2009 Feb
TI  - Fifty-two-week efficacy and safety of vildagliptin vs. glimepiride in patients 
      with type 2 diabetes mellitus inadequately controlled on metformin monotherapy.
PG  - 157-66
LID - 10.1111/j.1463-1326.2008.00994.x [doi]
AB  - AIM: To examine the efficacy and safety of vildagliptin vs. glimepiride as add-on 
      therapy to metformin in patients with type 2 diabetes mellitus in a 52-week 
      interim analysis of a large, randomized, double-blind, multicentre study. The 
      primary objective was to demonstrate non-inferiority of vildagliptin vs. 
      glimepiride in glycosylated haemoglobin (HbA(1c)) reduction at week 52. METHODS: 
      Patients inadequately controlled on metformin monotherapy (HbA(1c) 6.5-8.5%) and 
      receiving a stable dose of metformin (mean dose 1898 mg/day; mean duration of use 
      36 months) were randomized 1:1 to receive vildagliptin (50 mg twice daily, n = 
      1396) or glimepiride (titrated up to 6 mg/day; mean dose 4.5 mg/day, n = 1393). 
      RESULTS: Non-inferiority of vildagliptin was demonstrated (97.5% confidence 
      interval 0.02%, 0.16%) with a mean (SE) change from baseline HbA(1c) (7.3% in 
      both groups) to week 52 endpoint of -0.44% (0.02%) with vildagliptin and -0.53% 
      (0.02%) with glimepiride. Although a similar proportion of patients reached a 
      target HbA(1c) level of <7% with vildagliptin and glimepiride (54.1 and 55.5%, 
      respectively), a greater proportion of patients reached this target without 
      hypoglycaemia in the vildagliptin group (50.9 vs. 44.3%; p < 0.01). Fasting 
      plasma glucose (FPG) reductions were comparable between groups (mean [SE] -1.01 
      [0.06] mmol/l and -1.14 [0.06] mmol/l respectively). Vildagliptin significantly 
      reduced body weight relative to glimepiride (mean [SE] change from baseline -0.23 
      [0.11] kg; between-group difference -1.79 kg; p < 0.001) and resulted in a 
      10-fold lower incidence of hypoglycaemia than glimepiride (1.7 vs. 16.2% of 
      patients presenting at least one hypoglycaemic event; 39 vs. 554 hypoglycaemic 
      events, p < 0.01). No severe hypoglycaemia occurred with vildagliptin compared 
      with 10 episodes with glimepiride (p < 0.01), and no patient in the vildagliptin 
      group discontinued because of hypoglycaemia compared with 11 patients in the 
      glimepiride group. The incidence of adverse events (AEs), serious AEs and 
      adjudicated cardiovascular events was 74.5, 7.1 and 0.9%, respectively, in 
      patients receiving vildagliptin, and 81.1, 9.5 and 1.6%, respectively, in 
      patients receiving glimepiride. CONCLUSIONS: When metformin alone fails to 
      maintain sufficient glycaemic control, the addition of vildagliptin provides 
      comparable efficacy to that of glimepiride after 52 weeks and displays a 
      favourable AE profile, with no weight gain and a significant reduction in 
      hypoglycaemia compared with glimepiride.
FAU - Ferrannini, E
AU  - Ferrannini E
AD  - Department of Internal Medicine and CNR Institute of Clinical Physiology, 
      University of Pisa, Pisa, Italy.
FAU - Fonseca, V
AU  - Fonseca V
FAU - Zinman, B
AU  - Zinman B
FAU - Matthews, D
AU  - Matthews D
FAU - Ahren, B
AU  - Ahren B
FAU - Byiers, S
AU  - Byiers S
FAU - Shao, Q
AU  - Shao Q
FAU - Dejager, S
AU  - Dejager S
LA  - eng
PT  - Journal Article
PT  - Multicenter Study
PT  - Randomized Controlled Trial
PT  - Research Support, Non-U.S. Gov't
PL  - England
TA  - Diabetes Obes Metab
JT  - Diabetes, obesity & metabolism
JID - 100883645
RN  - 0 (Blood Glucose)
RN  - 0 (Hypoglycemic Agents)
RN  - 0 (Nitriles)
RN  - 0 (Pyrrolidines)
RN  - 0 (Sulfonylurea Compounds)
RN  - 6KY687524K (glimepiride)
RN  - 9100L32L2N (Metformin)
RN  - I6B4B2U96P (Vildagliptin)
RN  - PJY633525U (Adamantane)
SB  - IM
EIN - Diabetes Obes Metab. 2009 Apr;11(4):405
MH  - Adamantane/administration & dosage/adverse effects/*analogs & derivatives
MH  - Blood Glucose/metabolism
MH  - Body Weight/drug effects
MH  - Diabetes Mellitus, Type 2/blood/*drug therapy
MH  - Double-Blind Method
MH  - Drug Administration Schedule
MH  - Female
MH  - Humans
MH  - Hypoglycemic Agents/*administration & dosage/adverse effects
MH  - Male
MH  - Metformin/*administration & dosage/adverse effects
MH  - Middle Aged
MH  - Nitriles/*administration & dosage/adverse effects
MH  - Pyrrolidines/*administration & dosage/adverse effects
MH  - Sulfonylurea Compounds/*administration & dosage/adverse effects
MH  - Time Factors
MH  - Vildagliptin
EDAT- 2009/01/08 09:00
MHDA- 2009/08/06 09:00
CRDT- 2009/01/08 09:00
PHST- 2009/01/08 09:00 [entrez]
PHST- 2009/01/08 09:00 [pubmed]
PHST- 2009/08/06 09:00 [medline]
AID - DOM994 [pii]
AID - 10.1111/j.1463-1326.2008.00994.x [doi]
PST - ppublish
SO  - Diabetes Obes Metab. 2009 Feb;11(2):157-66. doi: 
      10.1111/j.1463-1326.2008.00994.x.