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DiabetesDiabCare AsiaNCT00874159

A Survey to Evaluate Diabetes Management, Control, Complications and Psychosocial Aspects of Diabetic Patients in Philippines

An observational study of Diabetes and Diabetes Mellitus, Type 1, run by Novo Nordisk A/S at 1 site in Philippines.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial summary

This study is conducted in Asia. The aim of this observational study is to describe the diabetes management, control status and complication profile in a diabetic population of Philippines. Read more about this study

Who is it for?
Ages 18 years and older
What is being tested?
No treatment given
How many people
770 participants
Where
1 sitePhilippines
Study dates
Apr 2009to Oct 2009
Phase
Observational
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

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 inclusion and exclusion criteria.

Who may be able to join

  • 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

Who cannot join

  • Repetition of any patient as patients should not be included twice for any reason
  • Unwilling to participate or unable to comply with protocol requirements

Trial locations and contacts

1 site in 1 country.

Philippines1 site

  • Study site

    Manila, 1605

Other trials in Philippines

About this study

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

This study is conducted in Asia. The aim of this observational study is to describe the diabetes management, control status and complication profile in a diabetic population of Philippines.

Being tested
No treatment given
Medical subject headings
Diabetes Mellitus, Diabetes Mellitus, Type 1, Diabetes Mellitus, Type 2

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • No treatment givenOther

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

Study groups in NCT00874159
Study groupRoleWhat they receive
ANot described
Receives: Other: No treatment given

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Mean age of onset of type 1 diabetes mellitus

    Measured: at baseline visit/study start

  2. Mean age of onset of type 2 diabetes mellitus

    Measured: at baseline visit/study start

  3. Mean duration of treatment of type 2 DM

    Measured: at baseline visit/study start

  4. Percentage of patients on Insulin therapy

    Measured: at baseline visit/study start

  5. Percentage of patients on OAD therapy

    Measured: at baseline visit/study start

  6. Mean duration of diabetes in type 1 and type 2 patients respectively

    Measured: at baseline visit/study start

  7. Mean FPG of diabetic patients

    Measured: at baseline visit/study start

  8. Mean PPG of diabetic patients

    Measured: at baseline visit/study start

  9. Mean HbA1c of diabetic patients

    Measured: at baseline visit/study start

  10. Percentage of diabetic patients with HbA1c target below 7.0%

    Measured: at baseline visit/study start

  11. Percentage of diabetic patients with HbA1c target below 6.5%

    Measured: at baseline visit/study start

  12. Percentage of diabetic patients having dyslipidemia and hypertension

    Measured: at baseline visit/study start

  13. Percentage of diabetic patients having cardiovascular complications

    Measured: at baseline visit/study start

  14. Percentage of diabetic patients having peripheral vascular disease

    Measured: at baseline visit/study start

  15. Percentage of diabetic patients having diabetic nephropathy

    Measured: at baseline visit/study start

  16. Percentage of diabetic patients having diabetic eye complications

    Measured: at baseline visit/study start

Secondary outcomes (4)

  1. Patients' perception will be analysed through Patient questionnaire measuring: Psychological well-being, Quality of life, Patients' compliant to treatment

    Measured: at baseline visit/study start

  2. Physician perception of diabetes and its management will be analysed through Physician questionnaire measuring awareness about:o HbA1c test and its goal,Anti-diabetic treatment,Barriers towards optimum diabetes control

    Measured: at baseline visit/study start

  3. Duration of diabetes associated with highest number of diabetic complications

    Measured: at baseline visit/study start

  4. Minimum duration of diabetes associated with 10% incidence of diabetic complications (CVD, nephropathy and retinopathy)

    Measured: at baseline visit/study start

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted2 Apr 2009 (estimated)
  2. Study startApr 2009
  3. Primary completionOct 2009
  4. Study completionOct 2009

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Observational
Observational model
Ecologic or community
Time perspective
Cross-sectional
Enrolment
770 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT00874159
Sponsor's protocol ID
INS-3712
Acronym
DiabCare Asia
Status last verified
Oct 2023
First submitted
31 Mar 2009
Last updated
2 Nov 2023
Results posted
No
Data monitoring committee
No

Questions about this trial

What is this clinical trial studying?

An observational study of Diabetes and Diabetes Mellitus, Type 1, run by Novo Nordisk A/S at 1 site in Philippines.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 3 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 2 Nov 2023. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Philippines. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Mean age of onset of type 1 diabetes mellitus (time frame: at baseline visit/study start). The study lists 16 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT00874159.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 2 Nov 2023.

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