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Improved glycaemic control with vildagliptin added to insulin, with or without metformin, in patients with type 2 diabetes mellitus.
MedLine Citation:
PMID:  23039321     Owner:  NLM     Status:  Publisher    
Abstract/OtherAbstract:
AIM: Assess the efficacy and safety of vildagliptin 50 mg bid as add-on therapy to insulin in type 2 diabetes mellitus (T2DM) METHODS: Multicenter, double-blind, placebo-controlled, parallel group, clinical trial in T2DM patients inadequately controlled by stable insulin therapy, with or without metformin. Patients received treatment with vildagliptin 50 mg bid or placebo for 24 weeks RESULTS: In all, 449 patients were randomised to vildagliptin (n=228) or placebo (n=221). After 24 weeks, the difference in adjusted mean change in HbA1c between vildagliptin and placebo was -0.7 ± 0.1% (p < 0.001) in the overall study population, -0.6 ± 0.1% (p < 0.001) in the subgroup also receiving metformin, and -0.8 ± 0.2% (p < 0.001) in the subgroup without metformin. Vildagliptin therapy was well tolerated, had a similarly low incidence of hypoglycaemia compared with placebo (8.4% vs 7.2%, p=n.s.) in spite of improved glycaemic control, and was not associated with weight gain. (+0.1 kg vs -0.4 kg) CONCLUSIONS: Vildagliptin 50 mg bid added to insulin significantly reduced HbA1c in patients with T2DM inadequately controlled by insulin, with or without metformin. Vildagliptin was well tolerated, with a safety profile similar to placebo. These results were achieved without weight gain or significant effects on hypoglycaemia incidence or severity in spite of improved glycaemic control.
Authors:
W Kothny; J Foley; P Kozlovski; Q Shao; B Gallwitz; V Lukashevich
Publication Detail:
Type:  JOURNAL ARTICLE     Date:  2012-10-5
Journal Detail:
Title:  Diabetes, obesity & metabolism     Volume:  -     ISSN:  1463-1326     ISO Abbreviation:  Diabetes Obes Metab     Publication Date:  2012 Oct 
Date Detail:
Created Date:  2012-10-8     Completed Date:  -     Revised Date:  -    
Medline Journal Info:
Nlm Unique ID:  100883645     Medline TA:  Diabetes Obes Metab     Country:  -    
Other Details:
Languages:  ENG     Pagination:  -     Citation Subset:  -    
Copyright Information:
© 2012 Blackwell Publishing Ltd.
Affiliation:
Novartis Pharmaceuticals, East Hanover, NJ, USA.
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