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A Cross-Sectional Survey to Evaluate Diabetes Management, Control, Complications, Psychosocial Aspects of Patients With Type 2 Diabetes in Indonesia (DiabCare Asia)

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT01934686
First Posted: September 4, 2013
Last Update Posted: May 28, 2014
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 Indonesia.

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 Indonesia

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 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: 1862
Study Start Date: September 2013
Study Completion Date: March 2014
Primary Completion Date: March 2014 (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

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Ages Eligible for Study:   18 Years and older   (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): NCT01934686


Locations
Indonesia
Jakarta, Indonesia, 12520
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: NCT01934686     History of Changes
Other Study ID Numbers: INS-4070
U1111-1138-9049 ( Other Identifier: WHO )
First Submitted: August 30, 2013
First Posted: September 4, 2013
Last Update Posted: May 28, 2014
Last Verified: May 2014

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