Safety and Efficacy Study to Compare Vildagliptin to Pioglitazone as Adding on Metformin in Type 2 Diabetes
Condition: Type 2 Diabetes
MeSH terms: Diabetes Mellitus, Type 2
Study type: Interventional
Phase: Phase 4

Summary: 
      The purpose of this study is to compare the effect of 16 weeks treatment with vildagliptin to
      pioglitazone as add-on the therapy to metformin in patients with type 2 diabetes inadequately
      controlled with metformin monotherapy.
    

Detailed description: 
      Type 2 diabetes mellitus (T2DM) is a chronic progressive disease characterized by
      hyperglycemia that result from pancreatic islet dysfunction. Presently available oral
      antihypoglycemic drug improves glycemic control over the short term, none has been shown to
      stop the progressive decline in beta cell function which contributes to the deterioration of
      glycemic control over time.

      Pathophysiology of T2DM is known as tissue resistance for insulin and progressive beta cell
      failure. Which one attributes first is unclear, but non-obese T2DM patients often show normal
      fasting plasma glucose (FPG) but postprandial plasma glucose (PPG) level is high and reduced
      or lacking normal compensatory insulin secretion. In Korea, more than 80% of T2DM are
      non-obese type (BMI >= 27 ) and it was observed that basal insulin level and compensatory
      insulin secretion reaction were reduced in normal healthy population. Based on that,
      metformin is an established first line treatment for type 2 diabetes, acting primarily to
      enhance hepatic and peripheral insulin sensitivity. However, it has become increasingly
      apparent that many patients require a combination of agents to attain optimal glycemic
      control.

      Better understanding of incretin effect on the pathophysiology of T2DM has recently led to
      development of new oral hypoglycemic agents. Vildagliptin is a potent and highly selective
      dipeptidyl peptidase (DPP)-IV inhibitor that improves islet function by increasing pancreatic
      alpha and beta cell responsiveness to glucose. Studies in patients with T2DM have shown that
      vildagliptin significantly reduced HbA1c and FPG level from baseline and did not induce
      weight gain and the incidence of hypoglycemia was low. In addition, studies in rodents
      support an effort of vildagliptin on beta cell remodeling.

      The thiazolidinediones are effective in reducing HbA1C in obese T2DM patients and it is known
      that only thiazolidinedione can delay the beta cell failure . But recently,
      thiazolidinediones were found to be associated with a decrease in bone mineral density and to
      raise the risk of myocardial infarct and cardiovascular related mortality. Thus, there is a
      need for new classes of blood glucose lowering drug which has the potential to delay or
      prevent the progression of T2DM.
    

Intervention name(s): vildagliptin; Pioglitazone
Intervention type(s): Drug; Drug
Intervention description(s): vildagliptin 50mg bid for 16 weeks; Pioglitazone 15mg bid for 16 weeks
Other intervention name(s): Galvus; Actos
Intervention MeSH terms: Pioglitazone; Vildagliptin
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: vildagliptin; metformin