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

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ClinicalTrials.gov Identifier: NCT00877526
Recruitment Status : Completed
First Posted : April 7, 2009
Last Update Posted : November 22, 2016
Sponsor:
Information provided by (Responsible Party):
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.

Condition or disease Intervention/treatment
Diabetes Diabetes Mellitus, Type 1 Diabetes Mellitus, Type 2 Other: No treatment given

Study Type : Observational
Actual Enrollment : 1670 participants
Observational Model: Ecologic or Community
Time Perspective: Cross-Sectional
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
Study Start Date : May 2009
Actual Primary Completion Date : September 2009
Actual Study Completion Date : September 2009

Resource links provided by the National Library of Medicine

U.S. FDA Resources

Group/Cohort Intervention/treatment
A Other: No treatment given
Subject will only fill out a questionaire when entering the observational study.



Primary Outcome Measures :
  1. Mean age of onset of type 1 and type 2 diabetes mellitus, respectively [ Time Frame: at baseline visit/study start ]
  2. Mean duration of treatment of type 2 Diabetes mellitus [ Time Frame: at baseline visit/study start ]
  3. Percentage of patients on insulin and Oral Anti-Diabetics Drugs (OADs) theraphy, respectively [ Time Frame: at baseline visit/study start ]
  4. Mean duration of diabetes in type 1 and type 2 diabetic patients respectively [ Time Frame: at baseline visit/study start ]
  5. Mean FPG (Fasting plasma glucose), PPG (Post prandial glucose) and HbA1c of diabetic patients [ Time Frame: at baseline visit/study start ]
  6. Percentage of diabetic patients with HbA1c target below 7.0% and below 6.5%, respectively [ Time Frame: at baseline visit/study start ]
  7. Percentage of diabetic patients having dyslipidemia and hypertension, cardiovascular complications, peripheral vascular disease, diabetic nephropathy and diabetic eye complications, respectively [ Time Frame: at baseline visit/study start ]

Secondary Outcome Measures :
  1. Patients' perception will be analysed through patient questionnaire measuring: Psychological well-being, Quality of Life and patients' compliant to treatmen [ Time Frame: at baseline visit/study start ]
  2. 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 [ Time Frame: at baseline visit/study start ]
  3. Duration of diabetes associated with highest number of diabetic complications [ Time Frame: at baseline visit/study start ]
  4. Minimum duration of diabetes associated with 10% incidence of diabetic complications (CVD, Nephropathy and retinopathy) [ Time Frame: at baseline visit/study start ]

Biospecimen Retention:   Samples With DNA
Capillary or venous blood will be drawn for analysing HbA1c.


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Ages Eligible for Study:   Child, Adult, Senior
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
Patients with diabetes mellitus (both type 1 and type 2) being treated at general hospitals, diabetes clinics and referral clinics will be selected according to the inclusion and exclusion criteria.
Criteria

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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00877526


Locations
Malaysia
Novo Nordisk Investigational Site
Selangor Darul Ehsan, Malaysia
Sponsors and Collaborators
Novo Nordisk A/S
Investigators
Study Director: Global Clinical Registry (GCR, 1452) Novo Nordisk A/S

Additional Information:
Responsible Party: Novo Nordisk A/S
ClinicalTrials.gov Identifier: NCT00877526     History of Changes
Other Study ID Numbers: INS-3723
First Posted: April 7, 2009    Key Record Dates
Last Update Posted: November 22, 2016
Last Verified: November 2016

Additional relevant MeSH terms:
Diabetes Mellitus
Diabetes Mellitus, Type 2
Diabetes Mellitus, Type 1
Glucose Metabolism Disorders
Metabolic Diseases
Endocrine System Diseases
Autoimmune Diseases
Immune System Diseases