Efficiency and Safety of Six Month Oglition® Therapy of Patients with Diabetes Mellitus type 2

Study type

• Study topic:
  Human medicinal product
• Study type:
  Non-interventional study
• Scope of the study:
  Assessment of risk minimisation measure implementation or effectiveness

  Other
• If ‘other’, further details on the scope of the study:
  Efficacy
• Data collection methods:
  Primary data collection

Non-interventional study

• Non-interventional study design:
  Cohort

Study drug and medical condition

• Name of medicine, other:
  Oglition

Population studied

• Short description of the study population:
  Adult patients with Diabetes Mellitus type 2 with HbA1c values ranging from 7% to 9.5% while on monotherapy by metformin (in the dose of 1 or 2 g), or on dual therapy by metformin (in dose of 1 or 2 g) and glimepiride (in dose of 2-4 g).
• Age groups:
  • Adult and elderly population (≥18 years)

    • Adults (18 to < 65 years)

      • Adults (18 to < 46 years)
      • Adults (46 to < 65 years)
    • Elderly (≥ 65 years)

      • Adults (65 to < 75 years)
      • Adults (75 to < 85 years)
      • Adults (85 years and over)
• Special population of interest:
  Other
• Special population of interest, other:
  Diabetes mellitus patients
• Estimated number of subjects:
  440

Study design details

• Main study objective:
  Obtain information on efficacy and safety.
• Outcomes:
  Monitoring of change of level of HbA1C before and during therapy by pioglitazone·Determining of glucose level on an empty stomach before and during therapy by pioglitazone·Monitoring of frequency of occurrence of hypoglycaemiaMonitoring of satisfaction with therapy, Monitoring of efficiency and safety of the drug Oglition® in the subgroup of patients on the previous monotherapy by metformin.Monitoring of efficiency and safety of the drug Oglition® in the subgroup of patients on the previous dual therapy by metformin and glimepiride.
• Data analysis plan:
  measures of risk