Insulin Initiation and Adherence Behaviours: a Cross Sect... | NCT06517784

Studies
Insulin Initiation and Adherence Behaviours: a Cross Sectional Survey of Indian HCPs & Patients With Type 2 Diabetes

NCT06517784

Sponsor

Novo Nordisk A/S

Status

Completed

Last Update Posted

Aug 28, 2024Actual

Enrollment

752Actual

Phase

Not provided

Conditions

Type 2 Diabetes

Interventions

No treatment given

Countries

India

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

ID	Type	Description	Link
U1111-1302-7518	Other Identifier	World Health Organization (WHO)

Status Module

Record Verification Date

Aug 2024

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Jul 5, 2024Actual

Primary Completion Date

Aug 16, 2024Actual

Completion Date

Aug 16, 2024Actual

First Submitted Date

Jul 18, 2024

First Submission Date that Met QC Criteria

Jul 18, 2024

First Posted Date

Jul 24, 2024Actual

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Aug 27, 2024

Last Update Posted Date

Aug 28, 2024Actual

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Not provided

Is FDA Regulated Device

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

Brief Summary

This is a cross-sectional study planned among patients with Type 2 Diabetes (T2D) and Health Care Providers (HCPs) who treat T2D patients. Study participants will be recruited through existing databases/panels to complete a 30-minute self-administered online survey. The purpose of the study is to understand the insulinization barriers and the insulin adherence behaviours of both HCPs and patients.

Detailed Description

Not provided

Design Module

Study Type

Observational

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Target Follow-Up Duration

Not provided

Phases

Not provided

Interventional Study Design

Allocation

Not provided

Intervention Model

Biospecimen

No data available

No data is available for this block.

Enrollment

752Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
Patients		Patients with type 2 diabetes	Other: No treatment given
Health care providers		Health care providers who treat patients with type 2 diabetes	Other: No treatment given

Interventions

Name	Type	Description	Arm Group Labels	Other Names
No treatment given	Other	No treatment given	Health care providers Patients

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
The barriers toward insulin initiation among HCPs & patients	Barriers to insulin initiation = Likert scale: 1=Strongly disagree, 5=Strongly agree	At time of data abstraction (Day 1)

Secondary Outcomes

Not provided

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

For patients

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, age above or equal to 18 years at the time of signing informed consent.
Diagnosed with T2D
Currently seeing an HCP for T2D
Initiated on insulin within the past 12 months
Prescribed insulin on a permanent basis
Currently taking insulin via a vial and syringe or insulin pen

For HCP

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, age above or equal to 18 years at the time of signing informed consent.
Primary care physician (PCP) with degree in internal medicine or general medicine, diabetologist with degree in internal medicine or general medicine plus diploma in diabetology, or endocrinologist
Has been in practice a minimum of 2 years
Diabetologist/endocrinologist: treats at least 50 T2D patients per month
PCP: treats at least 40 T2D patients per month
Currently initiates T2D patients on insulin
Treats 20 percent or more of T2D patients with insulin

Exclusion Criteria:

Previous participation in this study. Participation is defined as having given informed consent in this study
Mental incapacity, unwillingness or language barriers precluding adequate understanding or cooperation

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

Not provided

Standard Ages

AdultOlder Adult

Study Population

Patients with Type 2 Diabetes (T2D) and Health Care Providers (HCPs) who treat T2D patients

Sampling Method

Non-Probability Sample

Name	Affiliation	Role
Clinical Transparency dept. 2834	Novo Nordisk A/S	Study Director

IPD Sharing Statement Module

Plan to Share IPD

Yes

Description

According to the Novo Nordisk disclosure commitment on novonordisk-trials.com

Types

Not provided

Time Frame

Not provided

Access Criteria

Not provided

URL

https://novonordisk-trials.com

ID	Term
D003920	Diabetes Mellitus
D044882	Glucose Metabolism Disorders
D008659	Metabolic Diseases
D009750	Nutritional and Metabolic Diseases