PMID- 17300592
OWN - NLM
STAT- MEDLINE
DCOM- 20071105
LR  - 20221207
IS  - 1462-8902 (Print)
IS  - 1462-8902 (Linking)
VI  - 9
IP  - 2
DP  - 2007 Mar
TI  - Vildagliptin in combination with pioglitazone improves glycaemic control in 
      patients with type 2 diabetes failing thiazolidinedione monotherapy: a 
      randomized, placebo-controlled study.
PG  - 166-74
AB  - AIM: The purpose of this study was to assess the efficacy and tolerability of the 
      dipeptidyl peptidase-4 inhibitor vildagliptin in combination with the 
      thiazolidinedione (TZD) pioglitazone in patients with type 2 diabetes (T2DM). 
      METHODS: This was a 24-week, multicentre, double-blind, randomized, 
      parallel-group study comparing the effects of vildagliptin (50 or 100 mg daily) 
      with placebo as an add-on therapy to pioglitazone (45 mg daily) in 463 patients 
      with T2DM inadequately controlled by prior TZD monotherapy. Between-treatment 
      comparisons of efficacy parameters were made by analysis of covariance model. 
      RESULTS: The adjusted mean change (AM Delta) in haemoglobin A(1c) from baseline 
      to endpoint was -0.8 +/- 0.1% (p = 0.001 vs. placebo) and -1.0 +/- 0.1% (p < 
      0.001 vs. placebo), respectively, in patients receiving vildagliptin 50 or 100 mg 
      daily. Relative to baseline, vildagliptin added to pioglitazone also reduced 
      fasting plasma glucose (FPG) (AM Delta FPG =-0.8 +/- 0.2 mmol/l and -1.1 +/- 0.2 
      mmol/l; not significant (NS) vs. placebo) and postprandial glucose (PPG) [AM 
      Delta PPG =-1.9 +/- 0.6 mmol/l and -2.6 +/- 0.6 mmol/l (p = 0.008 vs. placebo)] 
      for 50 and 100 mg daily respectively. Relative to placebo, both doses of 
      vildagliptin significantly increased the insulin secretory rate/glucose by more 
      than threefold. The overall incidence of adverse events (AEs) was 55.5, 50.0 and 
      48.7% in patients receiving vildagliptin 50 mg, 100 mg daily or placebo 
      respectively. Serious AEs were experienced by 6.8, 1.3 and 5.7% of patients 
      receiving vildagliptin 50 mg, 100 mg daily or placebo respectively. Mild 
      hypoglycaemia was reported by 0, 0.6 and 1.9% of patients, respectively, 
      receiving vildagliptin 50 mg, 100 mg daily or placebo. CONCLUSION: Vildagliptin 
      is effective and well tolerated when added to a maximum dose of pioglitazone, 
      without increasing the risk of hypoglycaemia.
FAU - Garber, A J
AU  - Garber AJ
AD  - Division of Endocrinology, Baylor College of Medicine, Houston, TX 77030, USA. 
      agarber@bcm.tmc.edu
FAU - Schweizer, A
AU  - Schweizer A
FAU - Baron, M A
AU  - Baron MA
FAU - Rochotte, E
AU  - Rochotte E
FAU - Dejager, S
AU  - Dejager S
LA  - eng
SI  - ClinicalTrials.gov/NCT00099853
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 (Dipeptidyl-Peptidase IV Inhibitors)
RN  - 0 (Glycated Hemoglobin A)
RN  - 0 (Hypoglycemic Agents)
RN  - 0 (Insulin)
RN  - 0 (Ligands)
RN  - 0 (Lipids)
RN  - 0 (Nitriles)
RN  - 0 (Protease Inhibitors)
RN  - 0 (Pyrrolidines)
RN  - 0 (Thiazolidinediones)
RN  - 0 (hemoglobin A1c protein, human)
RN  - 9035-68-1 (Proinsulin)
RN  - AA68LXK93C (2,4-thiazolidinedione)
RN  - EC 3.4.14.5 (DPP4 protein, human)
RN  - EC 3.4.14.5 (Dipeptidyl Peptidase 4)
RN  - I6B4B2U96P (Vildagliptin)
RN  - PJY633525U (Adamantane)
RN  - X4OV71U42S (Pioglitazone)
SB  - IM
MH  - Adamantane/adverse effects/*analogs & derivatives/therapeutic use
MH  - Adult
MH  - Aged
MH  - Blood Glucose/metabolism
MH  - Body Weight
MH  - Diabetes Mellitus, Type 2/blood/*drug therapy
MH  - Dipeptidyl Peptidase 4
MH  - Dipeptidyl-Peptidase IV Inhibitors
MH  - Double-Blind Method
MH  - Drug Therapy, Combination
MH  - Female
MH  - Glycated Hemoglobin/metabolism
MH  - Humans
MH  - Hypoglycemic Agents/adverse effects/*therapeutic use
MH  - Insulin/blood
MH  - Insulin-Secreting Cells/physiology
MH  - Ligands
MH  - Lipids/blood
MH  - Male
MH  - Middle Aged
MH  - Nitriles/adverse effects/*therapeutic use
MH  - Pioglitazone
MH  - Proinsulin/blood
MH  - Protease Inhibitors/therapeutic use
MH  - Pyrrolidines/adverse effects/*therapeutic use
MH  - Thiazolidinediones/adverse effects/*therapeutic use
MH  - Treatment Failure
MH  - Treatment Outcome
MH  - Vildagliptin
EDAT- 2007/02/16 09:00
MHDA- 2007/11/06 09:00
CRDT- 2007/02/16 09:00
PHST- 2007/02/16 09:00 [pubmed]
PHST- 2007/11/06 09:00 [medline]
PHST- 2007/02/16 09:00 [entrez]
AID - DOM684 [pii]
AID - 10.1111/j.1463-1326.2006.00684.x [doi]
PST - ppublish
SO  - Diabetes Obes Metab. 2007 Mar;9(2):166-74. doi: 10.1111/j.1463-1326.2006.00684.x.