Healthcare Professional Survey to Assess the Effectiveness of Risk Evaluation and Mitigation Strategy for Dulaglutide (H9X-MC-B002)

Study type

• Study topic:
  Human medicinal product
• Study type:
  Non-interventional study
• Scope of the study:
  Assessment of risk minimisation measure implementation or effectiveness
• Data collection methods:
  Primary data collection

Non-interventional study

• Non-interventional study design:
  Cross-sectional

  Other
• Non-interventional study design, other:
  Survey Design

Study drug and medical condition

• Study drug International non-proprietary name (INN) or common name:
  DULAGLUTIDE

Population studied

• Short description of the study population:
  Certain health care professionals (HCPs) who have prescribed TRULICITY to at least 1 patient.; The participant must: live in the US, be a current or past prescriber of TRULICITY, and be an HCP (including physicians [family practice, internal medicine, and endocrinologists], nurse practitioners, physician assistants)
• Age groups:
  • Adults (18 to < 46 years)
  • Adults (46 to < 65 years)
  • Adults (65 to < 75 years)
  • Adults (75 to < 85 years)
  • Adults (85 years and over)
• Estimated number of subjects:
  201

Study design details

• Main study objective:
  This primary study objective is to evaluate the impact of the risk evaluation and mitigation strategy on HCP and understanding regarding the risk of pancreatitis and the potential risk of medullary thyroid carcinoma associated with dulaglutide therapy as communicated through the risk evaluation and mitigation strategy
• Outcomes:
  The risk evaluation and mitigation strategy will be considered effective if the majority of respondents demonstrate they are aware of the key risks communicated.
• Data analysis plan:
  Data collected from the survey will be reported as descriptive statistics. Frequency distributions with 95% CIs will be calculated for respondent responses to all questions that address the survey objectives.