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A multi-hospital approach that depicts the routine practice of doctors treating patients with type 2 diabetes with Novomix 30, which will evaluate willingness and ability to pay in a real world population.

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 - NA

Status
Active, not recruiting
Phases
Phase 4
Study type
Observational
Source
CTRI
Registry ID
CTRI/2017/10/010218
Enrollment
666
Registered
2017-10-26
Start date
Unknown
Completion date
Unknown
Last updated
2021-11-24

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Health Condition 1: null- Diabetes Mellitus Health Condition 2: E08-E13- Diabetes mellitus

Interventions

Intervention1: Biphasic insulin aspart I.P. (NovoMix� 30 Penfill®): Mixture of insulin aspart and protamine crystallised insulin aspart, dose-NovoMix 30 50 70, 24 hours-duration, subcutaneous admin

Sponsors

Novo Nordisk India Private Ltd
Lead Sponsor

Eligibility

Inclusion criteria

Inclusion criteria: 1. 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. 2. 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. 3. Signed informed consent obtained before any study-related activities (study-related activities are any procedure related to recording of data according to the protocol). 4. Male or female more than or equal to 18 years at time of informed consent. 5. Diagnosed with T2DM and treated with BHI in vials for at least three consecutive months at time of informed consent.

Exclusion criteria

Exclusion criteria: 1. Previous participation in this study. Participation is defined as having given informed consent in this study. 2. Concurrent participation in any other clinical trial or study. 3. Patients previously treated with insulin analogues. 4. 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® 3011) or related products. 5. Mental incapacity, unwillingness, or language barriers precluding adequate understanding or cooperation. 6. Patients who are unable to read or write (illiterate).

Design outcomes

Primary

MeasureTime frame
The primary objective is to assess the proportion of patients with T2DM, previously treated with BHI in vials for at least 3 months, who are able and willing to pay for BIAsp 30 in a FlexPen® at Week 12 following the first prescription of BIAsp 30 (as part of a patientâ??s usual care).Timepoint: 6 months

Secondary

MeasureTime frame
To assess patientsâ?? preferences for BIAsp 30 attributes and satisfaction with treatment in general and the delivery device in particular. To investigate any difference in the characteristics of patients with T2DM that were treated with BHI in vials prior to the first prescription of BIAsp 30 and who are willing to pay for BIAsp 30 in a pen device after 12 weeks of treatment versus patients who are not able or willing to pay.Timepoint: 6 months

Countries

Egypt, India

Contacts

Public ContactDr Bharathi R

Novo Nordisk India Private Ltd.

ansd@novonordisk.com9148526835

Outcome results

None listed

Source: CTRI (via WHO ICTRP) · Data processed: Feb 4, 2026