A Cross-Sectional Survey to Evaluate Diabetes Management, Control, Complications, Psychosocial Aspects of Patients With Type 2 Diabetes in Bangladesh, Indonesia, Malaysia, Philippines, Sri Lanka and Vietnam (DiabCare Asia)

October 21, 2019 updated by: Novo Nordisk A/S
This study is conducted in Asia. The aim of this non-interventional study is to evaluate the current status of diabetes management, control, and complications in diabetic subjects in Vietnam.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Observational

Enrollment (Actual)

1631

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

  • Vietnam
      • Hanoi, Vietnam
        • Novo Nordisk Investigational Site

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
  • CHILD

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

Study Population

People having been treated for at least a year are eligible for the study. The selection of the patients will be done randomly by the individual physician involved in the study.

Description

Inclusion Criteria:

  • People with type 2 diabetes mellitus (DM) who are being treated, with any of the non-pharmacological or pharmacological options, at a particular centre for at least 1 year and who have visited the centre within the last 3-6 months
  • Patients willing to sign informed consent form

Exclusion Criteria:

  • Previous participation in this study
  • Unable to comply with protocol requirements
  • Confirmed or suspected pregnancy

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
Subjects with diabetes mellitus (type 2)
Other: No treatment given
Patients will fill out a questionnaire by interview.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Proportion of patients having HbA1c ((Glycosylated Haemoglobin) as measured during survey) less than 7%
Time Frame: Evaluated at the first visit (only one study visit)
Evaluated at the first visit (only one study visit)

Secondary Outcome Measures

Outcome Measure
Time Frame
Mean Fasting Plasma Glucose (FPG) of patients
Time Frame: Evaluated at the first visit (only one study visit)
Evaluated at the first visit (only one study visit)
Mean Postprandial Plasma Glucose (PPG) of patients
Time Frame: Evaluated at the first visit (only one study visit)
Evaluated at the first visit (only one study visit)
Mean HbA1c of patients
Time Frame: Evaluated at the first visit (only one study visit)
Evaluated at the first visit (only one study visit)
Proportion of patients having dyslipidemia
Time Frame: Evaluated at the first visit (only one study visit)
Evaluated at the first visit (only one study visit)
Proportion of patients having hypertension
Time Frame: Evaluated at the first visit (only one study visit)
Evaluated at the first visit (only one study visit)
Proportion of patients having cardiovascular complications
Time Frame: Evaluated at the first visit (only one study visit)
Evaluated at the first visit (only one study visit)
Proportion of patients having peripheral vascular disease
Time Frame: Evaluated at the first visit (only one study visit)
Evaluated at the first visit (only one study visit)
Proportion of patients having diabetic nephropathy
Time Frame: Evaluated at the first visit (only one study visit)
Evaluated at the first visit (only one study visit)
Proportion of patients having diabetic eye complications
Time Frame: Evaluated at the first visit (only one study visit)
Evaluated at the first visit (only one study visit)

Collaborators and Investigators

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

Sponsor

Novo Nordisk A/S

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

  • Nguyen KT, Diep BTT, Nguyen VKD, Lam HV, Tran KQ, Tran NQ. A cross-sectional study to evaluate diabetes management, control and complications in 1631 patients with type 2 diabetes mellitus in Vietnam (DiabCare Asia). Int J Diabetes Dev Ctries 2019 [Epub ahead of print] DOI: 10.1007/s13410-019-00755-w

Helpful Links

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)

April 22, 2015

Primary Completion (ACTUAL)

August 31, 2015

Study Completion (ACTUAL)

August 31, 2015

Study Registration Dates

First Submitted

February 13, 2014

First Submitted That Met QC Criteria

February 19, 2014

First Posted (ESTIMATE)

February 20, 2014

Study Record Updates

Last Update Posted (ACTUAL)

October 23, 2019

Last Update Submitted That Met QC Criteria

October 21, 2019

Last Verified

October 1, 2019

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • INS-4069
  • U1111-1137-2575 (OTHER: WHO)

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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