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Clinical Trial Details

Trial ID: L2283
Source ID: NCT03374774
Associated Drug: Biasp 30
Title: A Non-interventional Study of Ability and Willingness to Pay for BIAsp 30 in a Real World Population With Type 2 Diabetes Mellitus (T2DM)
Acronym:
Status: COMPLETED
Study Results: NO
Results:
Conditions: Diabetes|Diabetes Mellitus, Type 2
Interventions: DRUG: BIAsp 30
Outcome Measures: 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|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|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|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|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|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
Sponsor/Collaborators: Sponsor: Novo Nordisk A/S
Gender: ALL
Age: ADULT, OLDER_ADULT
Phases:
Enrollment: 516
Study Type: OBSERVATIONAL
Study Designs: Observational Model: |Time Perspective: p
Start Date: 2017-11-13
Completion Date: 2018-07-04
Results First Posted:
Last Update Posted: 2018-08-31
Locations: Novo Nordisk Investigational Site, Guwahati, Assam, 781006, India|Novo Nordisk Investigational Site, Ahmedabad, Gujarat, 380054, India|Novo Nordisk Investigational Site, Bangalore, Karnataka, 560092, India|Novo Nordisk Investigational Site, Bangalore, Karnataka, India|Novo Nordisk Investigational Site, Gulbarga, Karnataka, 585105, India|Novo Nordisk Investigational Site, Mysore, Karnataka, 570004, India|Novo Nordisk Investigational Site, Kolhapur, Maharashtra, India|Novo Nordisk Investigational Site, Nasik, Maharashtra, India|Novo Nordisk Investigational Site, Pune, Maharashtra, India|Novo Nordisk Investigational Site, Coimbatore, Tamil Nadu, 641009, India|Novo Nordisk Investigational Site, Coimbatore, Tamil Nadu, 641018, India|Novo Nordisk Investigational Site, Madurai, Tamil Nadu, 625 020, India|Novo Nordisk Investigational Site, Lucknow, Uttar Pradesh, 226005, India|Novo Nordisk Investigational Site, Lucknow, Uttar Pradesh, India|Novo Nordisk Investigational Site, Kolkata, West Bengal, 700054, India|Novo Nordisk Investigational Site, Belgaum, 590010, India|Novo Nordisk Investigational Site, New Delhi, 110017, India|Novo Nordisk Investigational Site, Thriruvananthapuram, 695 032, India
URL: https://clinicaltrials.gov/show/NCT03374774