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

August 27, 2024 updated by: Novo Nordisk A/S
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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Observational

Enrollment (Actual)

752

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • India
      • Bangalore, India
        • Novo Nordisk India

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Sampling Method

Non-Probability Sample

Study Population

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

Description

Inclusion Criteria:

For patients

  1. Informed consent obtained before any study-related activities (study-related activities are any procedure related to recording of data according to the protocol).
  2. Male or female, age above or equal to 18 years at the time of signing informed consent.
  3. Diagnosed with T2D
  4. Currently seeing an HCP for T2D
  5. Initiated on insulin within the past 12 months
  6. Prescribed insulin on a permanent basis
  7. Currently taking insulin via a vial and syringe or insulin pen

For HCP

  1. Informed consent obtained before any study-related activities (study-related activities are any procedure related to recording of data according to the protocol).
  2. Male or female, age above or equal to 18 years at the time of signing informed consent.
  3. 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
  4. Has been in practice a minimum of 2 years
  5. Diabetologist/endocrinologist: treats at least 50 T2D patients per month
  6. PCP: treats at least 40 T2D patients per month
  7. Currently initiates T2D patients on insulin
  8. Treats 20 percent or more of T2D patients with insulin

Exclusion Criteria:

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
Patients
Patients with type 2 diabetes
Other: No treatment given
No treatment given
Health care providers
Health care providers who treat patients with type 2 diabetes
Other: No treatment given
No treatment given

What is the study measuring?

Primary Outcome Measures

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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Novo Nordisk A/S

Investigators

  • Study Director: Clinical Transparency dept. 2834, Novo Nordisk A/S

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

July 5, 2024

Primary Completion (Actual)

August 16, 2024

Study Completion (Actual)

August 16, 2024

Study Registration Dates

First Submitted

July 18, 2024

First Submitted That Met QC Criteria

July 18, 2024

First Posted (Actual)

July 24, 2024

Study Record Updates

Last Update Posted (Actual)

August 28, 2024

Last Update Submitted That Met QC Criteria

August 27, 2024

Last Verified

August 1, 2024

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • NN000-7941
  • U1111-1302-7518 (Other Identifier: World Health Organization (WHO))

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

YES

IPD Plan Description

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

Drug and device information, study documents

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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