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

• PURI:
  https://redirect.ema.europa.eu/resource/21063
• 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 institution 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

Study protocol

Initial protocol

F3Z-MC-B019_EU-PAS-Registered

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)