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

Diabetes Mellitus, Type 2 Clinical Trial

— DiabCare Asia  

Official title:

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 (Bangladesh)

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00839878
• Other study ID #: INS-3738
• Status: Completed
• Phase: N/A
• First received: February 6, 2009
• Last updated: October 13, 2016
• Start date: March 2009
• Est. completion date: March 2009

Study information

• Verified date: October 2016
• Source: Novo Nordisk A/S
• Contact: n/a
• Is FDA regulated: No
• Health authority: Bangladesh: Drug Control Administration
• 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, complications in diabetic subjects in Asia.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 2092
• Est. completion date: March 2009
• Est. primary completion date: March 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
Bangladesh	Novo Nordisk Investigational Site	Dhaka

Sponsors (1)

Lead Sponsor	Collaborator
Novo Nordisk A/S

Country where clinical trial is conducted

Bangladesh, 

Outcome

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 eye complications		at baseline visit/study start	No
Primary	Percentage of diabetic patients having diabetic nephropathy		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 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 and 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