Comparison of safety and efficacy of vildagliptin versus NPH insulin add-on to glimepiride in patients with type 2 diabetes mellitus

Update Il y a 4 ans
Reference: EUCTR2012-001143-46

Woman and Man

  • | Country :
  • -
  • | organs :
  • -
  • | Specialty :
  • -

Extract

1. To demonstrate that add-on to glimeperide vildagliptin is superior to NPH insulin with respect to the incidence of the combined endpoint, defined as a blood glucose target (HbA1c below 7.0%) without any confirmed hypoglycemic events (BG measurement < 3.9mM (71mg/dL)) and weight gain (+3%) in T2DM patients. 2. To demonstrate that add-on to glimepiride vildagliptin is superior to NPH insulin with respect to the rate of of confirmed hypoglycemic events (BG measurement < 3.9mM (71mg/dL)) in T2DM patients.


Inclusion criteria

  • type-2 diabetes mellitus that do not reach adequate glycemic control on their current sulfonylurea monotherapy

Links