Healthcare Professional and Patient Surveys to Assess the Effectiveness of Risk Minimisation Measures for Concentrated Insulin Lispro (Humalog 200 units/ml KwikPen; Liprolog 200 units/ml KwikPen) (F3Z-MC-B019)

Study identification

• EU PAS number:
  EUPAS13422
• Study ID:
  21063
• Official title and acronym:
  Healthcare Professional and Patient Surveys to Assess the Effectiveness of Risk Minimisation Measures for Concentrated Insulin Lispro (Humalog 200 units/ml KwikPen; Liprolog 200 units/ml KwikPen) (F3Z-MC-B019)
• DARWIN EU® study:
  No
• Study countries:
  France

  Germany

  Sweden
• Study description:
  This study aims to evaluate the impact of the additional risk minimisation measures on healthcare professional and patient understanding and behaviour regarding the risk of hypoglycaemia and/or hyperglycaemia due to medication errors associated with administration of Humalog KwikPen 200 units/ml. The study will be conducted in France, Germany, and Sweden within 12-18 months of product launch.
• Study status:
  Finalised

Research institutions and networks

Institutions

United BioSource Corporation (UBC)

Switzerland

Study timelines

Date when funding contract was signed

Planned:31/10/2014

Actual:31/10/2014

Study start date

Planned:30/06/2016

Actual:16/05/2016

Date of final study report

Planned:30/06/2017

Actual:29/03/2017

Sources of funding

Pharmaceutical company and other private sector 

More details on funding

Eli Lilly and Company

Regulatory

• Was the study required by a regulatory body?:
  No
• Is the study required by a Risk Management Plan (RMP)?:
  EU RMP category 3 (required)