Healthcare Professional Survey to Assess the Effectiveness of Additional Risk Minimization Measures for Prescribing and Administration of Concentrated Insulin Human (Humulin R U-500 KwikPen) (B5K-MC-B012)

Study identification

• PURI:
  https://redirect.ema.europa.eu/resource/21607
• EU PAS number:
  EUPAS21539
• Study ID:
  21607
• 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 KwikPen) (B5K-MC-B012)
• 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 hypoglycemia associated with Humulin R U-500 KwikPen and educational points to be emphasized in discussion with patients.
• 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: 31/07/2017

Date of final study report

Planned: 31/10/2017

Sources of funding

Pharmaceutical company and other private sector 

More details on funding

Eli Lilly and Company

Study protocol

Initial protocol

B5K-MC-B012_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