A Non-interventional Study of Ability and Willingness to Pay for BIAsp 30 in a Real World Population With Type 2 Diabetes Mellitus (T2DM)

Diabetes Mellitus, Type 2 Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03374774
• Other study ID #: BIASP-4343
• Secondary ID: U1111-1195-7991
• Status: Completed
• Start date: November 13, 2017
• Est. completion date: July 4, 2018

Study information

• Verified date: August 2018
• Source: Novo Nordisk A/S
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 516
• Est. completion date: July 4, 2018
• Est. primary completion date: July 4, 2018
• Gender: All
• Age group: 18 Years and older

Eligibility

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)

Related Conditions & MeSH terms

• Diabetes
• Diabetes Mellitus
• Diabetes Mellitus, Type 2

Intervention

Drug:
• BIAsp 30
Participants will receive commercially available BIAsp 30 according to routine clinical practice. The physician will determine the starting dose and any potential later change to the dose.

Locations

Country	Name	City	State
India	Novo Nordisk Investigational Site	Ahmedabad	Gujarat
India	Novo Nordisk Investigational Site	Bangalore	Karnataka
India	Novo Nordisk Investigational Site	Bangalore	Karnataka
India	Novo Nordisk Investigational Site	Belgaum
India	Novo Nordisk Investigational Site	Coimbatore	Tamil Nadu
India	Novo Nordisk Investigational Site	Coimbatore	Tamil Nadu
India	Novo Nordisk Investigational Site	Gulbarga	Karnataka
India	Novo Nordisk Investigational Site	Guwahati	Assam
India	Novo Nordisk Investigational Site	Kolhapur	Maharashtra
India	Novo Nordisk Investigational Site	Kolkata	West Bengal
India	Novo Nordisk Investigational Site	Lucknow	Uttar Pradesh
India	Novo Nordisk Investigational Site	Lucknow	Uttar Pradesh
India	Novo Nordisk Investigational Site	Madurai	Tamil Nadu
India	Novo Nordisk Investigational Site	Mysore	Karnataka
India	Novo Nordisk Investigational Site	Nasik	Maharashtra
India	Novo Nordisk Investigational Site	New Delhi
India	Novo Nordisk Investigational Site	Pune	Maharashtra
India	Novo Nordisk Investigational Site	Thriruvananthapuram

Sponsors (1)

Lead Sponsor	Collaborator
Novo Nordisk A/S

Country where clinical trial is conducted

India, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Proportion of patients who are using BIAsp 30 as their primary insulin	Proportion of patients	Week 12
Secondary	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	This questionnaire consists of a physician's part and a patient's part. The questionnaire reflects the socio-economic and lifestyle characteristics of patients.	Week 12
Secondary	Change from baseline to Week 12 after first prescription of BIAsp 30 in treatment satisfaction, measured by Diabetes Treatment Satisfaction Questionnaire (status)	The DTSQs questionnaire will be used to assess subject's treatment satisfaction. This instrument contains 8 items and measures the treatment for your diabetes (including insulin, tablets and/or diet) in terms of convenience, flexibility and general feelings regarding treatment.	Week 0, week 12
Secondary	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	The TRIM-D Device is an eight item measure with two domains assessing Device Bother and Device Function. This captures information on the ease of use, convenience, and handling of the device(s) used to take diabetes medication. The measure has acceptable reliability, validity and ability to detect change.	Week 0, week 12
Secondary	Diabetes Pen Experience Measure (DPEM) Scores (proportions of each item)	This measure captures information on the convenience, user friendliness, and handling of pen, which is used to administer BIAsp 30. Seven items are scored on a 5 point scale from 'Not at all' to 'Extremely'. Proportion of each item to be presented.	Week 0
Secondary	Weighted patient preferences for treatment attributes derived from the Discrete Choice Experiment (DCE)	Through multiple scenarios, each patient will be prompted to select the choice that seems most favourable to the patient. Each scenario will consist of a bundled collection of attributes relevant for insulin therapy. The questionnaire consists of approximately nine questions/scenarios for each patient.	Week 0
Secondary	Diabetes Pen Experience Measure (DPEM) Scores (frequency of each item)	This measure captures information on the convenience, user friendliness, and handling of pen, which is used to administer BIAsp 30. Seven items are scored on a 5 point scale from 'Not at all' to 'Extremely'. Frequency of each item to be presented.	Week 0