NCT01950650

Brief Summary

This study is conducted in Asia, Europe and in the United States of America. The aim of this study is to examine patient and physician beliefs regarding insulin therapy and the degree to which patients adhere to their insulin regimens.

Trial Health

98
On Track

Trial Health Score

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

Enrollment
1,800

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Mar 2010

Shorter than P25 for all trials

Geographic Reach
10 countries

10 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

Study Start

First participant enrolled

March 1, 2010

Completed
6 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 1, 2010

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

September 1, 2010

Completed
3.1 years until next milestone

First Submitted

Initial submission to the registry

September 23, 2013

Completed
2 days until next milestone

First Posted

Study publicly available on registry

September 25, 2013

Completed
Last Updated

April 27, 2017

Status Verified

April 1, 2017

Enrollment Period

6 months

First QC Date

September 23, 2013

Last Update Submit

April 25, 2017

Conditions

Outcome Measures

Primary Outcomes (2)

  • Frequency of insulin omission/non-adherence

    In the past 30 days prior to the day when responding to the survey (patient survey)

  • Reasons for insulin omission/non-adherence reported by patient and physician

    Day 1 (when responding to the survey)

Secondary Outcomes (1)

  • Impact of insulin treatment on life domains (patient survey)

    Day 1 (when responding to the online questionnaire)

Study Arms (2)

Patients with diabetes

Behavioral: No treatment given

Physicians

Behavioral: survey

Interventions

Survey conducted through computer-assisted telephone interviewing.

Patients with diabetes
surveyBEHAVIORAL

Survey conducted via the Internet.

Physicians

Eligibility Criteria

Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)
Sampling MethodProbability Sample
Study Population

Insulin treated patients with diabetes (type 1 or 2), and physicians involved in the treatment, management of diabetes and care of patients with diabetes.

You may qualify if:

  • PATIENTS WITH DIABETES:
  • Age 18 years or older
  • Treated with insulin
  • Type 1 or Type 2 diabetes
  • PHYSICIANS:
  • In practice for more than 1 year since completing residency
  • See a minimum number of patients with diabetes per week (primary care physicians 5, specialists 10)
  • Initiate insulin treatment for patients with diabetes

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (10)

Novo Nordisk Investigational Site

Princeton, New Jersey, 08540, United States

Location

Novo Nordisk Investigational Site

Beijing, Beijing Municipality, 100004, China

Location

Novo Nordisk Investigational Site

Paris La Défense Cedex, 92932, France

Location

Novo Nordisk Investigational Site

Mainz, 55127, Germany

Location

Novo Nordisk Investigational Site

Bangalore, 560001, India

Location

Novo Nordisk Investigational Site

Tokyo, 1000005, Japan

Location

Novo Nordisk Investigational Site

Moscow, 119330, Russia

Location

Novo Nordisk Investigational Site

Madrid, 28033, Spain

Location

Novo Nordisk Investigational Site

Istanbul, 34335, Turkey (Türkiye)

Location

Novo Nordisk Investigational Site

Crawley, RH11 9RT, United Kingdom

Location

Related Publications (1)

  • Peyrot M, Barnett AH, Meneghini LF, Schumm-Draeger PM. Insulin adherence behaviours and barriers in the multinational Global Attitudes of Patients and Physicians in Insulin Therapy study. Diabet Med. 2012 May;29(5):682-9. doi: 10.1111/j.1464-5491.2012.03605.x.

Related Links

MeSH Terms

Conditions

Diabetes MellitusDiabetes Mellitus, Type 1Diabetes Mellitus, Type 2

Interventions

Surveys and Questionnaires

Condition Hierarchy (Ancestors)

Glucose Metabolism DisordersMetabolic DiseasesNutritional and Metabolic DiseasesEndocrine System DiseasesAutoimmune DiseasesImmune System Diseases

Intervention Hierarchy (Ancestors)

Data CollectionEpidemiologic MethodsInvestigative TechniquesHealth Care Evaluation MechanismsQuality of Health CareHealth Care Quality, Access, and EvaluationPublic HealthEnvironment and Public Health

Study Officials

  • Global Clinical Registry (GCR, 1452)

    Novo Nordisk A/S

    STUDY DIRECTOR

Study Design

Study Type
observational
Observational Model
ECOLOGIC OR COMMUNITY
Time Perspective
CROSS SECTIONAL
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

September 23, 2013

First Posted

September 25, 2013

Study Start

March 1, 2010

Primary Completion

September 1, 2010

Study Completion

September 1, 2010

Last Updated

April 27, 2017

Record last verified: 2017-04

Locations