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NCT01934686 Clinical Trial

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

Diabetes Mellitus, Type 2 Clinical Trial

— DiabCare Asia  

Official title:
A Cross-Sectional Survey to Evaluate Diabetes Management, Control, Complications, Psychosocial Aspects of Patients With Type 2 Diabetes in Indonesia

Clinical Trial Details — Status: Completed

Administrative data
NCT number NCT01934686
Other study ID # INS-4070
Secondary ID U1111-1138-9049
Status Completed
Phase N/A
First received August 30, 2013
Last updated May 26, 2014
Start date September 2013
Est. completion date March 2014

Study information
Verified date May 2014
Source Novo Nordisk A/S
Contact n/a
Is FDA regulated No
Health authority Indonesia: National Agency of Drug and Food Control
Study type Observational

Clinical Trial Summary

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.

Recruitment information / eligibility
Status Completed
Enrollment 1862
Est. completion date March 2014
Est. primary completion date March 2014
Accepts healthy volunteers No
Gender Both
Age group 18 Years and older
Eligibility 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 Design

Observational Model: Ecologic or Community, Time Perspective: Cross-Sectional

Related Conditions & MeSH terms

Intervention

Other:
• No treatment given
Patients will fill out a questionnaire by interview.

Locations
Country Name City State
n/a

Sponsors (1)
Lead Sponsor Collaborator
Novo Nordisk A/S

Country where clinical trial is conducted

Indonesia, 

Outcome
Type Measure Description Time frame Safety issue
Primary Proportion of patients having HbA1c ((Glycosylated Haemoglobin) as measured during survey) less than 7% Evaluated at the first visit (only one study visit) No
Secondary Mean Postprandial Plasma Glucose (PPG) of patients Evaluated at the first visit (only one study visit) No
Secondary Mean HbA1c of patients Evaluated at the first visit (only one study visit) No
Secondary Proportion of patients having dyslipidemia Evaluated at the first visit (only one study visit) No
Secondary Proportion of patients having hypertension Evaluated at the first visit (only one study visit) No
Secondary Proportion of patients having cardiovascular complications Evaluated at the first visit (only one study visit) No
Secondary Proportion of patients having peripheral vascular disease Evaluated at the first visit (only one study visit) No
Secondary Proportion of patients having diabetic nephropathy Evaluated at the first visit (only one study visit) No
Secondary Proportion of patients having diabetic eye complications Evaluated at the first visit (only one study visit) No
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