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

NCT ID: NCT03374774

Last Updated: 2018-08-31

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

516 participants

Study Classification

OBSERVATIONAL

Study Start Date

2017-11-13

Study Completion Date

2018-07-04

Brief Summary

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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.

Detailed Description

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Conditions

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Diabetes Diabetes Mellitus, Type 2

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Study Groups

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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®.

BIAsp 30

Intervention Type DRUG

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.

Interventions

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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.

Intervention Type DRUG

Eligibility Criteria

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Inclusion 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)
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Novo Nordisk A/S

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Clinical Reporting Anchor and Disclosure 1452

Role: STUDY_DIRECTOR

Novo Nordisk A/S

Locations

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Novo Nordisk Investigational Site

Guwahati, Assam, India

Site Status

Novo Nordisk Investigational Site

Ahmedabad, Gujarat, India

Site Status

Novo Nordisk Investigational Site

Bangalore, Karnataka, India

Site Status

Novo Nordisk Investigational Site

Bangalore, Karnataka, India

Site Status

Novo Nordisk Investigational Site

Kalaburagi, Karnataka, India

Site Status

Novo Nordisk Investigational Site

Mysore, Karnataka, India

Site Status

Novo Nordisk Investigational Site

Kolhāpur, Maharashtra, India

Site Status

Novo Nordisk Investigational Site

Nashik, Maharashtra, India

Site Status

Novo Nordisk Investigational Site

Pune, Maharashtra, India

Site Status

Novo Nordisk Investigational Site

Coimbatore, Tamil Nadu, India

Site Status

Novo Nordisk Investigational Site

Coimbatore, Tamil Nadu, India

Site Status

Novo Nordisk Investigational Site

Madurai, Tamil Nadu, India

Site Status

Novo Nordisk Investigational Site

Lucknow, Uttar Pradesh, India

Site Status

Novo Nordisk Investigational Site

Lucknow, Uttar Pradesh, India

Site Status

Novo Nordisk Investigational Site

Kolkata, West Bengal, India

Site Status

Novo Nordisk Investigational Site

Belagavi, , India

Site Status

Novo Nordisk Investigational Site

New Delhi, , India

Site Status

Novo Nordisk Investigational Site

Thriruvananthapuram, , India

Site Status

Countries

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India

References

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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.

Reference Type DERIVED
PMID: 33410093 (View on PubMed)

Other Identifiers

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U1111-1195-7991

Identifier Type: OTHER

Identifier Source: secondary_id

BIASP-4343

Identifier Type: -

Identifier Source: org_study_id

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