Healthcare Professional Survey to Assess the Effectiveness of Additional Risk Minimization Measures for Prescribing and Administration of Concentrated Insulin Human (Humulin R U-500 vial) Using the Dedicated U-500 Insulin Syringe (B5K-MC-B013)

Study identification

• PURI:
  https://redirect.ema.europa.eu/resource/23544
• EU PAS number:
  EUPAS23516
• Study ID:
  23544
• Official title and acronym:
  Healthcare Professional Survey to Assess the Effectiveness of Additional Risk Minimization Measures for Prescribing and Administration of Concentrated Insulin Human (Humulin R U-500 vial) Using the Dedicated U-500 Insulin Syringe (B5K-MC-B013)
• DARWIN EU® study:
  No
• Study countries:
  United States
• Study description:
  This study aims to evaluate the impact of the Dear Health Care Provider letter on prescriber understanding about the risk of potential dosing errors associated with the use and administration of Humulin R U-500 vial using the dedicated U-500 insulin syringe.
• Study status:
  Planned

Research institutions and networks

Institutions

Covance

Study timelines

Date when funding contract was signed

Planned: 30/11/2016

Study start date

Planned: 31/01/2018

Date of final study report

Planned: 30/04/2018

Sources of funding

Pharmaceutical company and other private sector 

More details on funding

Eli Lilly and Company

Study protocol

Initial protocol

B5K-MC-B013_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