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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)

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT02066766
First Posted: February 20, 2014
Last Update Posted: December 7, 2016
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by (Responsible Party):
Novo Nordisk A/S
  Purpose
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.

Condition Intervention
Diabetes Diabetes Mellitus, Type 2 Other: No treatment given

Study Type: Observational
Study Design: Observational Model: Ecologic or Community
Time Perspective: Cross-Sectional
Official Title: 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

Resource links provided by NLM:


Further study details as provided by Novo Nordisk A/S:

Primary Outcome Measures:
  • 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) ]

Secondary Outcome Measures:
  • Mean Fasting Plasma Glucose (FPG) of patients [ Time Frame: 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) ]
  • Mean HbA1c of patients [ Time Frame: 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) ]
  • Proportion of patients having hypertension [ Time Frame: 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) ]
  • Proportion of patients having peripheral vascular disease [ Time Frame: 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) ]
  • Proportion of patients having diabetic eye complications [ Time Frame: Evaluated at the first visit (only one study visit) ]

Enrollment: 1631
Study Start Date: April 2015
Study Completion Date: August 2015
Primary Completion Date: August 2015 (Final data collection date for primary outcome measure)
Groups/Cohorts Assigned Interventions
Subjects with diabetes mellitus (type 2) Other: No treatment given
Patients will fill out a questionnaire by interview.

  Eligibility

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Ages Eligible for Study:   Child, Adult, Senior
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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.
Criteria

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
  Contacts and Locations
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02066766


Locations
Vietnam
Novo Nordisk Investigational Site
Hanoi, Vietnam
Sponsors and Collaborators
Novo Nordisk A/S
Investigators
Study Director: Global Clinical Registry (GCR, 1452) Novo Nordisk A/S
  More Information

Additional Information:
Responsible Party: Novo Nordisk A/S
ClinicalTrials.gov Identifier: NCT02066766     History of Changes
Other Study ID Numbers: INS-4069
U1111-1138-8556 ( Other Identifier: WHO )
First Submitted: February 13, 2014
First Posted: February 20, 2014
Last Update Posted: December 7, 2016
Last Verified: December 2016

Additional relevant MeSH terms:
Diabetes Mellitus
Diabetes Mellitus, Type 2
Glucose Metabolism Disorders
Metabolic Diseases
Endocrine System Diseases