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

Study identification

• EU PAS number:
  EUPAS13117
• Study ID:
  17136
• Official title and acronym:
  Efficiency and Safety of Six Month Oglition® Therapy of Patients with Diabetes Mellitus type 2
• DARWIN EU® study:
  No
• Study countries:
  Serbia
• Study description:
  Primary goal:Monitoring of efficiency and safety of the drug Oglition® in therapy of diabetes mellitus type 2 in the period of 6 months.Secondary goals: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.
• Study status:
  Finalised

Research institutions and networks

Institutions

Actavis

Multiple centres: 5 centers are involved in the study

Study timelines

Date when funding contract was signed

Planned: 01/11/2014

Actual: 01/11/2014

Study start date

Planned: 01/05/2015

Actual: 01/05/2015

Date of final study report

Planned: 30/09/2016

Actual: 08/01/2017

Sources of funding

Pharmaceutical company and other private sector 

More details on funding

Actavis

Regulatory

• Was the study required by a regulatory body?:
  No
• Is the study required by a Risk Management Plan (RMP)?:
  Not applicable