title: Multifactorial effects of vildagliptin added to ongoing metformin therapy in patients with type 2 diabetes mellitus.
abstract: BACKGROUND
  To assess the efficacy of a vildagliptin and metformin combination therapy to a metformin monotherapy in type 2 diabetes mellitus patients.
  
  
  METHODS
  Sixty-one patients with diabetes inadequately controlled by a metformin monotherapy were randomized to treatment with a combination therapy of vildagliptin 100mg and a metformin versus metformin monotherapy. This was a 12-week randomized parallel group study. During the study we assessed parameters of glycemic and lipid metabolism as well as the treatment effects on the release of proinflammatory and antiinflammatory cytokines.
  
  
  RESULTS
  Compared with baseline values we observed a significant improvement of glycaemic parameters such as HbA1c, FPG, PPG, FPI, HOMA-IR and HOMA-β index as well as decrease of TCh, TG and LDL and an increase of HDL with the greatest extent of vildagliptin plus a low-dose metformin therapy group. A metformin combination therapy significantly decreased such inflamation parameters as hs-CRP, ox-LDL, TNF-α and IL-1β levels relative to monotherapies. All treatments were well tolerated and there was no incidence of hypoglycaemia.
  
  
  CONCLUSIONS
  Vildagliptin added to an ongoing metformin therapy allows to achieve better metabolic control parameters in comparison with a metformin monotherapy and the combination treatment is well tolerated and has a low risk of serious adverse effects.
authors.affiliation: Department of Internal Medicine, Diabetology and Nephrology, Medical University of Silesia, Zabrze, Poland.
authors.forename: Agnieszka
authors.initials: A
authors.lastname: Strózik
authors.affiliation: Department of Neurology, Medical University of Silesia, Katowice, Poland.
authors.forename: Arkadiusz
authors.initials: A
authors.lastname: Stęposz
authors.affiliation: Department of Internal Medicine and Clinical Pharmacology, Medical University of Silesia, Katowice, Poland. Electronic address: marbas@mp.pl.
authors.forename: Marcin
authors.initials: M
authors.lastname: Basiak
authors.affiliation: Department of Internal Medicine and Clinical Pharmacology, Medical University of Silesia, Katowice, Poland.
authors.forename: Magdalena
authors.initials: M
authors.lastname: Drożdż
authors.affiliation: Department of Internal Medicine and Clinical Pharmacology, Medical University of Silesia, Katowice, Poland.
authors.forename: Bogusław
authors.initials: B
authors.lastname: Okopień
mesh_terms: D000218:Adamantane / Q000009:adverse effects / Q000031:analogs & derivatives* / Q000627:therapeutic use; D000328:Adult; D000368:Aged; D001786:Blood Glucose / Q000378:metabolism; D001794:Blood Pressure / Q000187:drug effects; D015992:Body Mass Index; D008078:Cholesterol, LDL / Q000097:blood; D016207:Cytokines / Q000378:metabolism; D003924:Diabetes Mellitus, Type 2 / Q000097:blood / Q000188:drug therapy*; D004311:Double-Blind Method; D004359:Drug Therapy, Combination; D005260:Female; D006442:Glycated Hemoglobin / Q000032:analysis; D006801:Humans; D007004:Hypoglycemic Agents / Q000009:adverse effects / Q000627:therapeutic use*; D007328:Insulin / Q000097:blood; D008055:Lipids / Q000097:blood; D008297:Male; D008687:Metformin / Q000009:adverse effects / Q000627:therapeutic use*; D008875:Middle Aged; D009570:Nitriles / Q000009:adverse effects / Q000627:therapeutic use*; D011759:Pyrrolidines / Q000009:adverse effects / Q000627:therapeutic use*; D000077597:Vildagliptin
chemical_list: D000218:Adamantane; D001786:Blood Glucose; D008078:Cholesterol, LDL; D016207:Cytokines; D006442:Glycated Hemoglobin; D007004:Hypoglycemic Agents; D007328:Insulin; D008055:Lipids; D008687:Metformin; D009570:Nitriles; D011759:Pyrrolidines; D000077597:Vildagliptin
keywords: DPP-IV inhibitors; Diabetes; Glycaemic control; Lipid profile; Metformin