Clinical trial NCT03374774: A Non-interventional Study of Ability and Willingness to Pay for BIAsp 30 in a Real World Population With Type 2 Diabetes Mellitus (T2DM)
Official title: A Multi-centre Prospective, Non-interventional Study of Ability and Willingness to Pay for BIAsp 30 in a Real World Population With Type 2 Diabetes Mellitus
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Diabetes
Diabetes Mellitus, Type 2
Lead sponsor: Novo Nordisk A/S
Sponsor class: INDUSTRY
First posted: 2017-12-15
Enrollment: 516
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients with type 2 diabetes mellitus, previously treated with biphasic human insulin (BHI), who are prescribed and treated with commercially available BIAsp 30 from their treating physician as part of a usual care

Brief summary: The purpose of this study is to collect information about the participant's ability and willingness to pay for NovoMix 30 using a modern device, which is prescribed to the participant by the study doctor for Type 2 Diabetes Mellitus according to routine clinical practice. The study aims to obtain data that can guide prescribers' understanding of the ability and willingness to pay for NovoMix 30 FlexPen or Penfill among participants in the growing middle class in India and Egypt. The decision to prescribe NovoMix 30 FlexPen or Penfill has been made independent from this study.


Eligibility criteria: Inclusion Criteria: - The decision to initiate treatment with commercially available BIAsp 30 has been made by the patient and the treating physician before and independently from the decision to include the patient in this study - Patients selected by their physician for participation in the study, who are likely to be able and willing to pay for the BIAsp 30 treatment for at least 12 weeks from baseline visit as assessed by the treating physician - Signed informed consent obtained before any study-related activities (study-related activities are any procedure related to recording of data according to the protocol) - Male or female greater than or equal to 18 years at time of informed consent - Diagnosed with T2DM and treated with BHI in vials for at least three consecutive months at time of informed consent Exclusion Criteria: - Previous participation in this study. Participation is defined as having given informed consent in this study - Concurrent participation in any other clinical trial or study - Patients previously treated with insulin analogues - Known or suspected hypersensitivity to study product (or any of the excipients of the study product; a full list of excipients is provided in Summary of product characteristics (SmPC) of NovoMix® 30) or related products - Mental incapacity, unwillingness, or language barriers precluding adequate understanding or cooperation - Patients who are unable to read or write (illiterate)

Primary outcomes:
measure: Proportion of patients who are using BIAsp 30 as their primary insulin
timeFrame: Week 12
Secondary outcomes:
measure: Demographic and socio-economic characteristics of patients still using BIAsp 30 and of patients no longer using BIAsp 30 as their primary insulin, measured by Ability to Pay Questionnaire
timeFrame: Week 12
measure: Change from baseline to Week 12 after first prescription of BIAsp 30 in treatment satisfaction, measured by Diabetes Treatment Satisfaction Questionnaire (status)
timeFrame: Week 0, week 12
measure: Change from baseline to Week 12 after first prescription of BIAsp 30 in patient evaluation of delivery system, measured by Treatment Related Impact Measure for Diabetes (TRIM-D) Device
timeFrame: Week 0, week 12
measure: Diabetes Pen Experience Measure (DPEM) Scores (proportions of each item)
timeFrame: Week 0
measure: Weighted patient preferences for treatment attributes derived from the Discrete Choice Experiment (DCE)
timeFrame: Week 0
measure: Diabetes Pen Experience Measure (DPEM) Scores (frequency of each item)
timeFrame: Week 0
Other outcomes:
Locations:
city: Guwahati
country: India
facility: Novo Nordisk Investigational Site
state: Assam
city: Ahmedabad
country: India
facility: Novo Nordisk Investigational Site
state: Gujarat
city: Bangalore
country: India
facility: Novo Nordisk Investigational Site
state: Karnataka
city: Bangalore
country: India
facility: Novo Nordisk Investigational Site
state: Karnataka
city: Gulbarga
country: India
facility: Novo Nordisk Investigational Site
state: Karnataka
city: Mysore
country: India
facility: Novo Nordisk Investigational Site
state: Karnataka
city: Kolhapur
country: India
facility: Novo Nordisk Investigational Site
state: Maharashtra
city: Nasik
country: India
facility: Novo Nordisk Investigational Site
state: Maharashtra
city: Pune
country: India
facility: Novo Nordisk Investigational Site
state: Maharashtra
city: Coimbatore
country: India
facility: Novo Nordisk Investigational Site
state: Tamil Nadu
city: Coimbatore
country: India
facility: Novo Nordisk Investigational Site
state: Tamil Nadu
city: Madurai
country: India
facility: Novo Nordisk Investigational Site
state: Tamil Nadu
city: Lucknow
country: India
facility: Novo Nordisk Investigational Site
state: Uttar Pradesh
city: Lucknow
country: India
facility: Novo Nordisk Investigational Site
state: Uttar Pradesh
city: Kolkata
country: India
facility: Novo Nordisk Investigational Site
state: West Bengal
city: Belgaum
country: India
facility: Novo Nordisk Investigational Site
city: New Delhi
country: India
facility: Novo Nordisk Investigational Site
city: Thriruvananthapuram
country: India
facility: Novo Nordisk Investigational Site
Study officials:
affiliation: Novo Nordisk A/S
name: Clinical Reporting Anchor and Disclosure 1452
role: STUDY_DIRECTOR
References:
citation: Murthy S, Aneja P, Asirvatham AJ, Husemoen LLN, Rhee NA, Kesavadev J. Understanding Patients' Willingness to Pay for Biphasic Insulin Aspart 30/70 in a Pen Device for Type 2 Diabetes Treatment in an Out-of-Pocket Payment Market. Pharmacoecon Open. 2021 Jun;5(2):261-273. doi: 10.1007/s41669-020-00246-3. Epub 2021 Jan 6.