CClinicalTrials.gg
CompletedNCT00877526DiabCare AsiaUpdated Nov 22, 2016

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

An observational study in Diabetes, Diabetes Mellitus, Type 1 and Diabetes Mellitus, Type 2, sponsored by Novo Nordisk A/S. Completed at 1 site in Malaysia. Per ClinicalTrials.gov, last updated 2016-11-22.

Sponsored by Novo Nordisk A/S · Observational

Study type
Observational
Model
Ecologic or community
Time perspective
Cross-sectional
Enrollment
1,670
Sex
All
01

Study 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.

02

Conditions studied

  • Diabetes
  • Diabetes Mellitus, Type 1
  • Diabetes Mellitus, Type 2
03

In context

Diabetes Mellitus

10,925 studies on the registry are indexed under Diabetes Mellitus; 1,319 are open to participants now.

This study's enrollment of 1,670 is above the median of 233 across 2,220 observational studies indexed under Diabetes Mellitus.

Browse Diabetes Mellitus studies →

Lead sponsor

Novo Nordisk A/S is the lead sponsor of 1,370 studies on the registry; 101 are open to participants now.

Of its 198 completed or terminated interventional studies of FDA-regulated products, 94 (47%) have results posted.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
Child (0–17), Adult (18–64), Older adult (65+)
Sexes eligible
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.

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

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.
05

Study design

Observational model
Ecologic or community
Time perspective
Cross-sectional
Enrollment
1,670 participants (actual)
Patient registry
No
Biospecimen retention
Samples with dna

Groups and cohorts

  • A

    Other: No treatment given

Interventions

  • OtherNo treatment given

    Subject will only fill out a questionaire when entering the observational study.

06

What researchers measure

Primary outcomes

  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 outcomes

  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

07

Study locations

1 site
  • Novo Nordisk Investigational Site
    Selangor Darul Ehsan, Malaysia
08

References and documents

09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Nov 22, 2016, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT00877526
Lead sponsor
Novo Nordisk A/S
Responsible party
Sponsor
First posted
Apr 7, 2009
Start date
May 2009
Primary completion
Sep 2009
Completion
Sep 2009
Last update
Nov 22, 2016

Study contacts

Global Clinical Registry (GCR, 1452)
study director · Novo Nordisk A/S

Oversight

Data monitoring committee
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Nov 2016. You cannot join it, but the record below documents what was studied.

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