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

Completed

• Conditions: Diabetes Mellitus, Type 1; Diabetes; Diabetes Mellitus, Type 2
• Interventions: Other: No treatment given

• Registration Number: NCT00877526
• Lead Sponsor: Novo Nordisk A/S

Brief 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.

Detailed Description

Not available

Basic Information
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Recruitment & Eligibility
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Study & Design
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Trial Locations

Study Timeline

• Study First Submitted: 2009-04-06
• Study First Submitted QC: 2009-04-06
• Study First Posted: 2009-04-07
• Study Start: 2009-05
• Primary Completion: 2009-09
• Study Completion: 2009-09
• Status Verified: 2016-11
• Last Update Submitted: 2016-11-21
• Last Update Posted: 2016-11-22

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 1670

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.

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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.

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Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
A	No treatment given	-

Primary Outcome Measures

Name	Time	Method
Mean age of onset of type 1 and type 2 diabetes mellitus, respectively	at baseline visit/study start
Mean duration of treatment of type 2 Diabetes mellitus	at baseline visit/study start
Percentage of patients on insulin and Oral Anti-Diabetics Drugs (OADs) theraphy, respectively	at baseline visit/study start
Mean duration of diabetes in type 1 and type 2 diabetic patients respectively	at baseline visit/study start
Mean FPG (Fasting plasma glucose), PPG (Post prandial glucose) and HbA1c of diabetic patients	at baseline visit/study start
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
Percentage of diabetic patients with HbA1c target below 7.0% and below 6.5%, respectively	at baseline visit/study start

Secondary Outcome Measures

Name	Time	Method
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
Duration of diabetes associated with highest number of diabetic complications	at baseline visit/study start
Minimum duration of diabetes associated with 10% incidence of diabetic complications (CVD, Nephropathy and retinopathy)	at baseline visit/study start
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

Trial Locations

Locations (1)

Novo Nordisk Investigational Site; 🇲🇾 Selangor Darul Ehsan, Malaysia