NCT03374774|Completed

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

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

Novo Nordisk A/S ClinicalTrials.gov

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2 other identifiers

BIASP-4343U1111-1195-7991

Study Type

observational

Target

516

Locations

1 country

Sites

Timeline

RegisteredDec 2017

StartedNov 2017

CompletionJul 2018

Brief 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.

Trial Health

On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment

516

participants targeted

Target at P75+ for all trials

Timeline

Completed

Started Nov 2017

Shorter than P25 for all trials

Geographic Reach

1 country

18 active sites

Status

completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

8 months study duration

Study Start

First participant enrolled

November 13, 2017

Completed

22 days until next milestone

First Submitted

Initial submission to the registry

December 5, 2017

Completed

10 days until next milestone

First Posted

Study publicly available on registry

December 15, 2017

Completed

7 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 4, 2018

Completed

Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

July 4, 2018

Completed

Last Updated

August 31, 2018

Status Verified

August 1, 2018

Enrollment Period

8 months

First QC Date

December 5, 2017

Last Update Submit

August 28, 2018

Conditions

Diabetes Diabetes Mellitus, Type 2

Outcome Measures

Primary Outcomes (1)

Proportion of patients who are using BIAsp 30 as their primary insulin
Proportion of patients
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
Week 12
Change from baseline to Week 12 after first prescription of BIAsp 30 in treatment satisfaction, measured by Diabetes Treatment Satisfaction Questionnaire (status)
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
Week 0, week 12
Diabetes Pen Experience Measure (DPEM) Scores (proportions of each item)
Week 0
Weighted patient preferences for treatment attributes derived from the Discrete Choice Experiment (DCE)
Week 0
+1 more secondary outcomes

Study Arms (1)

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®.

Drug: BIAsp 30

Interventions

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.

Participants with Type 2 Diabetes Mellitus

Eligibility Criteria

Age18 Years+

Sexall

Age GroupsAdult (18-64), Older Adult (65+)

Sampling MethodNon-Probability Sample

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

Contact the study team to confirm eligibility.