Healthcare Professional and Patient Surveys to Assess the Effectiveness of Risk Minimization Measures for Concentrated Insulin Lispro (Humalog 200 units/mL KwikPen) (F3Z-MC-B020)

Study identification

• PURI:
  https://redirect.ema.europa.eu/resource/20643
• EU PAS number:
  EUPAS14789
• Study ID:
  20643
• Official title and acronym:
  Healthcare Professional and Patient Surveys to Assess the Effectiveness of Risk Minimization Measures for Concentrated Insulin Lispro (Humalog 200 units/mL KwikPen) (F3Z-MC-B020)
• DARWIN EU® study:
  No
• Study countries:
  United States
• Study description:
  This study aims to evaluate the impact of the additional risk minimization measures on healthcare professional and patient understanding and behavior regarding the risk of hypoglycemia and/or hyperglycemia due to medication errors associated with administration of Humalog KwikPen 200 units/ml. The study will be conducted in the United States within 18 months of product launch.
• Study status:
  Ongoing

Research institution and networks

Institutions

United BioSource Corporation (UBC)

Switzerland

Study timelines

Date when funding contract was signed

Planned: 31/10/2014

Study start date

Planned: 30/08/2016

Actual: 15/08/2016

Date of final study report

Planned: 30/01/2017

Sources of funding

Pharmaceutical company and other private sector 

More details on funding

Eli Lilly and Company

Study protocol

Initial protocol

F3Z-MC-B020_EU-PAS-Registered

Regulatory

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