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 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:
  INSULIN LISPRO

Population studied

• Short description of the study population:
  HCPs involved in the treatment and management of patients with diabetes who are aware of the insulin product Humalog 200 units/ml KwikPen were eligible. Patients who are 18 years or older, have diabetes and have been prescribed Humalog 200 units/ml KwikPen were eligible.; HCPs and patients in the United Kingdom (UK, if product uptake does not allow for participation, another comparable EU country will be selected), Germany, and one additional EU country, to be determined based on product launch and market uptake.
• Age groups:
  • Adult and elderly population (≥18 years)

    • Adults (18 to < 65 years)

      • Adults (18 to < 46 years)
      • Adults (46 to < 65 years)
    • Elderly (≥ 65 years)

      • Adults (65 to < 75 years)
      • Adults (75 to < 85 years)
      • Adults (85 years and over)
• Special population of interest:
  Other
• Special population of interest, other:
  Diabetes mellitus patients
• Estimated number of subjects:
  560

Study design details

• Main study objective:
  This primary study objective is to evaluate the impact of the risk minimisation measures on HCP and patient understanding regarding the risk of hypoglycaemia and/or hyperglycaemia due to medication errors associated with administration of Humalog KwikPen 200 units/ml as communicated through the risk minimisation measures.
• Outcomes:
  The risk minimisation tools 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.In addition to the overall analysis, survey data will be analysed to determine if there are any differences by country and, for HCPs, medical specialty.