Diabetes Mellitus, Type 2 Clinical Trial
— DiabCare AsiaOfficial title:
DiabCare Asia 2008. A Cross-sectional Survey to Evaluate Diabetes Management, Control, Complications, Psychosocial Aspects of Diabetic Patients in Asia and to Evaluate Perceptions and Practices of Physicians and Patients About Diabetes Management in Asia. DiabCare Asia 2008 - Indonesia
Verified date | June 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 |
This study is conducted in Asia. The aim of this observational study is to evaluate current status of diabetes management, control, complications in diabetic subjects in Asia. Further perceptions and practices of physicians and subjects about diabetes management in Asia will be evaluated.
Status | Completed |
Enrollment | 1832 |
Est. completion date | February 2009 |
Est. primary completion date | February 2009 |
Accepts healthy volunteers | No |
Gender | Both |
Age group | N/A and older |
Eligibility |
Inclusion Criteria: - Diabetic patients registered in the particular centre for more than 12 months. - Patients should have visited the centre at least once in the last 3-6 months before the initial study visit. - Patients willing to sign informed consent form. Exclusion Criteria: - Repetition of any patient as patients should not be included twice for any reason. - Unwilling to participate or unable to comply with protocol requirements. |
Observational Model: Ecologic or Community, Time Perspective: Cross-Sectional
Country | Name | City | State |
---|---|---|---|
n/a |
Lead Sponsor | Collaborator |
---|---|
Novo Nordisk A/S |
Indonesia,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Mean age of onset of either type 1 or type 2 diabetes mellitus | study visit | No | |
Primary | Mean duration of treatment of type 2 diabetes mellitus. | study visit | No | |
Primary | Percentage of patients on either insulin therapy or OAD (oral anti-diabetic drug) therapy. | study visit | No | |
Primary | Mean duration of diabetes in type 1 and type 2 diabetes patients respectively. | study visit | No | |
Primary | Mean FPG (fasting plasma glucose),PPG (post prandial glucose) and HbA1c of diabetic patients. | study visit | No | |
Primary | Percentage of diabetic patients with HbA1c target below or equal to 7.0%. | study visit | No | |
Primary | Percentage of diabetic patients with HbA1c target below or equal to 6.5%. | study visit | No | |
Primary | Percentage of diabetic patients having dyslipidemia and hypertension | study visit | No | |
Primary | Percentage of diabetic patients having cardiovascular complications | study visit | No | |
Primary | Percentage of diabetic patients having peripheral vascular disease | study visit | No | |
Primary | Percentage of diabetic patients having diabetic nephropathy | study visit | No | |
Primary | Percentage of diabetic patients having diabetic eye complications | study visit | No | |
Secondary | Patients' perception will be analysed through Patient questionnaire measuring:Psychological well-being, Quality of life and Patients' compliant to treatment | study visit | No | |
Secondary | Physician questionnaire measuring awareness about:HbA1c test and its goal, Anti-diabetic treatment and Barriers towards optimum diabetes control | study visit | No | |
Secondary | Duration of diabetes associated with highest number of diabetic complications | study visit | No | |
Secondary | Minimum duration of diabetes associated with 10% incidence of diabetic complications (CVD, nephropathy and retinopathy) | study visit | No |
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