DiabetesNCT03374774
A Non-interventional Study of Ability and Willingness to Pay for BIAsp 30 in a Real World Population With Type 2 Diabetes Mellitus (T2DM)
An observational study of Diabetes and Diabetes Mellitus, Type 2, run by Novo Nordisk A/S at 18 sites in India.
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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Diabetes, Diabetes Mellitus, Type 2
- What is being tested?
- BIAsp 30
- How many people
- 516 participants
- Where
- 18 sitesIndia
- Study dates
- 13 Nov 2017to 4 Jul 2018
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- Adult, Older adult
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
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)
Trial locations and contacts
18 sites in 1 country.
18 sites in 1 country
India18 sites
Novo Nordisk Investigational Site
Ahmedabad, Gujarat, 380054
Novo Nordisk Investigational Site
Bangalore, Karnataka, 560092
Novo Nordisk Investigational Site
Bangalore, Karnataka
Novo Nordisk Investigational Site
Belagavi, 590010
Novo Nordisk Investigational Site
Coimbatore, Tamil Nadu, 641009
Novo Nordisk Investigational Site
Coimbatore, Tamil Nadu, 641018
Novo Nordisk Investigational Site
Guwahati, Assam, 781006
Novo Nordisk Investigational Site
Kalaburagi, Karnataka, 585105
Novo Nordisk Investigational Site
Kolhāpur, Maharashtra
Novo Nordisk Investigational Site
Kolkata, West Bengal, 700054
Novo Nordisk Investigational Site
Lucknow, Uttar Pradesh, 226005
Novo Nordisk Investigational Site
Lucknow, Uttar Pradesh
Novo Nordisk Investigational Site
Madurai, Tamil Nadu, 625 020
Novo Nordisk Investigational Site
Mysore, Karnataka, 570004
Novo Nordisk Investigational Site
Nashik, Maharashtra
Novo Nordisk Investigational Site
New Delhi, 110017
Novo Nordisk Investigational Site
Pune, Maharashtra
Novo Nordisk Investigational Site
Thriruvananthapuram, 695 032
About this study
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
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.
- Conditions
- Diabetes, Diabetes Mellitus, Type 2
- Being tested
- BIAsp 30
- Medical subject headings
- Diabetes Mellitus, Diabetes Mellitus, Type 2
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
BIAsp 30Drug
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.
| Study group | Role | What they receive |
|---|---|---|
| Participants with Type 2 Diabetes Mellitus | Participants will be prescribed and treated with commercially available BIAsp 30 according to routine clinical practice at the discretion of the treating physician, independent of this study. The study will gather data over the course of routine treatment on willingness to pay for BIAsp 30 in FlexPen® or Penfill®. Receives: Drug: BIAsp 30 |
What is being measured
The primary outcome is the main question the study is designed to answer.
Proportion of patients who are using BIAsp 30 as their primary insulin
Proportion of patients
Measured: Week 12
Secondary outcomes (6)
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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: Week 0
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Dec 2017
- Study start13 Nov 2017
- Primary completion4 Jul 2018
- Study completion4 Jul 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for DiabetesStudies of the same condition, open and under way.
- More trials run by Novo Nordisk A/SThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 516 participants (actual)
Sponsor and investigators
- Lead sponsor
- Novo Nordisk A/S
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Clinical Reporting Anchor and Disclosure 1452, Study director, Novo Nordisk A/S
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03374774
- Sponsor's protocol ID
- BIASP-4343
- Other IDs
- U1111-1195-7991
- Status last verified
- Aug 2018
- First submitted
- 5 Dec 2017
- Last updated
- 31 Aug 2018
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: According to the Novo Nordisk disclosure commitment on novonordisk-trials.com
Publications
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.
PubMed 33410093
Study at a glance
From the registry record, last updated by the sponsor on 31 Aug 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT03374774
- Acronym / sponsor ID
- BIASP-4343
- Conditions
- Diabetes, Diabetes Mellitus, Type 2
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 516 participants (actual)
- Lead sponsor
- Novo Nordisk A/SIndustry (pharma, biotech, devices)
- Study start
- 13 Nov 2017 (actual)
- Primary completion
- 4 Jul 2018 (actual)
- Study completion
- 4 Jul 2018 (actual)
- First posted
- 15 Dec 2017 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Participants with Type 2 Diabetes Mellitus | – | Drug: BIAsp 30Participants will be prescribed and treated with commercially available BIAsp 30 according to routine clinical practice at the discretion of the treating physician, independent of this study. The study will gather data over the course of routine treatment on willingness to pay for BIAsp 30 in FlexPen® or Penfill®. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Age groups
- Adult, Older adult
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| BIAsp 30Participants 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. | Drug | Participants with Type 2 Diabetes Mellitus |
Primary outcome
Proportion of patients who are using BIAsp 30 as their primary insulin
Time frame: Week 12
Proportion of patients
6 secondary outcomes
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
Time frame: Week 12
Change from baseline to Week 12 after first prescription of BIAsp 30 in treatment satisfaction, measured by Diabetes Treatment Satisfaction Questionnaire (status)
Time frame: 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
Time frame: Week 0, week 12
Diabetes Pen Experience Measure (DPEM) Scores (proportions of each item)
Time frame: Week 0
Weighted patient preferences for treatment attributes derived from the Discrete Choice Experiment (DCE)
Time frame: Week 0
Diabetes Pen Experience Measure (DPEM) Scores (frequency of each item)
Time frame: Week 0
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 31 Aug 2018.
- Derived from this study: PubMed 33410093Murthy 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.
- Individual participant dataSharing planned: Yes. According to the Novo Nordisk disclosure commitment on novonordisk-trials.com
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Clinical Reporting Anchor and Disclosure 1452 study director
Novo Nordisk A/S
18 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Diabetes and Diabetes Mellitus, Type 2, run by Novo Nordisk A/S at 18 sites in India.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 31 Aug 2018. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 18 sites in India. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Proportion of patients who are using BIAsp 30 as their primary insulin (time frame: Week 12). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03374774, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 31 Aug 2018.