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
| Verified date | November 2016 |
| Source | Novo Nordisk A/S |
| Contact | n/a |
| Is FDA regulated | No |
| Health authority | Singapore: Health Sciences Authority |
| Study type | Observational |
This study is conducted in Asia. The aim of this observational study is to evaluate current status of diabetes management, control and complications in diabetic subjects in Asia.
| Status | Completed |
| Enrollment | 854 |
| Est. completion date | April 2009 |
| Est. primary completion date | April 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 apart from the initial 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 |
|---|---|---|---|
| Singapore | Novo Nordisk Investigational Site | Singapore |
| Lead Sponsor | Collaborator |
|---|---|
| Novo Nordisk A/S |
Singapore,
| Type | Measure | Description | Time frame | Safety issue |
|---|---|---|---|---|
| Primary | Mean age of onset of type 1 and 2 diabetes mellitus | at baseline visit/study start | No | |
| Primary | Mean duration of treatment of type 2 DM | at baseline visit/study start | No | |
| Primary | Percentage of patients on Insulin and OAD therapy | at baseline visit/study start | No | |
| Primary | Mean duration of diabetes in type 1 and type 2 patients respectively | at baseline visit/study start | No | |
| Primary | Mean FPG and PPG of diabetic patients | at baseline visit/study start | No | |
| Primary | Mean HbA1c of diabetic patients | at baseline visit/study start | No | |
| Primary | Percentage of diabetic patients with HbA1c target below or equal to 7.0% | at baseline visit/study start | No | |
| Primary | Percentage of diabetic patients with HbA1c target below or equal to 6.5% | at baseline visit/study start | No | |
| Primary | Percentage of diabetic patients having dyslipidemia and hypertension | at baseline visit/study start | No | |
| Primary | Percentage of diabetic patients having cardiovascular complications | at baseline visit/study start | No | |
| Primary | Percentage of diabetic patients having peripheral vascular disease | at baseline visit/study start | No | |
| Primary | Percentage of diabetic patients having diabetic nephropathy | at baseline visit/study start | No | |
| Primary | Percentage of diabetic patients having diabetic eye complications | at baseline visit/study start | No | |
| Secondary | Patients' perception will be analysed through Patient questionnaire measuring - Psychological well-being, Quality of life, Patients' compliant to treatment | at baseline visit/study start | No | |
| Secondary | Physician perception of diabetes and its management will be analysed through Physician questionnaire measuring awareness about - HbA1c test and its goal, Anti-diabetic treatment, Barriers towards optimum diabetes control | at baseline visit/study start | No | |
| Secondary | Duration of diabetes associated with highest number of diabetic complications | at baseline visit/study start | No | |
| Secondary | Minimum duration of diabetes associated with 10% incidence of diabetic complications (CVD, Nephropathy and retinopathy) | at baseline visit/study start | No |
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