A Survey to Evaluate Diabetes Management, Control, Chronic Complications, Psychosocial Aspects of Diabetic Subjects in Malaysia

Diabetes Mellitus, Type 2 Clinical Trial

— DiabCare Asia  

Official title:

DiabCare Asia 2008 (Malaysia): A Cross-Sectional Survey to Evaluate Diabetes Management, Control, Complications, Psychosocial Aspects of Diabetic Patients in Asia & To Evaluate Perceptions and Practices of Physicians & Patients About Diabetes Management in Asia

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00877526
• Other study ID #: INS-3723
• Status: Completed
• Phase: N/A
• First received: April 6, 2009
• Last updated: November 21, 2016
• Start date: May 2009
• Est. completion date: September 2009

Study information

• Verified date: November 2016
• Source: Novo Nordisk A/S
• Contact: n/a
• Is FDA regulated: No
• Health authority: Malaysia: Drug Control Authority (DCA)
• Study type: Observational

Clinical Trial Summary

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 1670
• Est. completion date: September 2009
• Est. primary completion date: September 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.

Study Design

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

Related Conditions & MeSH terms

• Diabetes
• Diabetes Mellitus
• Diabetes Mellitus, Type 1
• Diabetes Mellitus, Type 2

Intervention

Other:
• No treatment given
Subject will only fill out a questionaire when entering the observational study.

Locations

Country	Name	City	State
Malaysia	Novo Nordisk Investigational Site	Selangor Darul Ehsan

Sponsors (1)

Lead Sponsor	Collaborator
Novo Nordisk A/S

Country where clinical trial is conducted

Malaysia, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Mean age of onset of type 1 and type 2 diabetes mellitus, respectively		at baseline visit/study start	No
Primary	Mean duration of treatment of type 2 Diabetes mellitus		at baseline visit/study start	No
Primary	Percentage of patients on insulin and Oral Anti-Diabetics Drugs (OADs) theraphy, respectively		at baseline visit/study start	No
Primary	Mean duration of diabetes in type 1 and type 2 diabetic patients respectively		at baseline visit/study start	No
Primary	Mean FPG (Fasting plasma glucose), PPG (Post prandial glucose) and HbA1c of diabetic patients		at baseline visit/study start	No
Primary	Percentage of diabetic patients with HbA1c target below 7.0% and below 6.5%, respectively		at baseline visit/study start	No
Primary	Percentage of diabetic patients having dyslipidemia and hypertension, cardiovascular complications, peripheral vascular disease, diabetic nephropathy and diabetic eye complications, respectively		at baseline visit/study start	No
Secondary	Patients' perception will be analysed through patient questionnaire measuring: Psychological well-being, Quality of Life and patients' compliant to treatmen		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

External Links

•   Clinical Trials at Novo Nordisk