NCT00874159

Brief 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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
770

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Apr 2009

Shorter than P25 for all trials

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

March 31, 2009

Completed
1 day until next milestone

Study Start

First participant enrolled

April 1, 2009

Completed
1 day until next milestone

First Posted

Study publicly available on registry

April 2, 2009

Completed
6 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 1, 2009

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

October 1, 2009

Completed
Last Updated

November 2, 2023

Status Verified

October 1, 2023

Enrollment Period

6 months

First QC Date

March 31, 2009

Last Update Submit

October 31, 2023

Conditions

DiabetesDiabetes Mellitus, Type 1Diabetes Mellitus, Type 2

Outcome Measures

Primary Outcomes (16)

  • Mean age of onset of type 1 diabetes mellitus

    at baseline visit/study start

  • Mean age of onset of type 2 diabetes mellitus

    at baseline visit/study start

  • Mean duration of treatment of type 2 DM

    at baseline visit/study start

  • Percentage of patients on Insulin therapy

    at baseline visit/study start

  • Percentage of patients on OAD therapy

    at baseline visit/study start

  • Mean duration of diabetes in type 1 and type 2 patients respectively

    at baseline visit/study start

  • Mean FPG of diabetic patients

    at baseline visit/study start

  • Mean PPG of diabetic patients

    at baseline visit/study start

  • Mean HbA1c of diabetic patients

    at baseline visit/study start

  • Percentage of diabetic patients with HbA1c target below 7.0%

    at baseline visit/study start

  • Percentage of diabetic patients with HbA1c target below 6.5%

    at baseline visit/study start

  • Percentage of diabetic patients having dyslipidemia and hypertension

    at baseline visit/study start

  • Percentage of diabetic patients having cardiovascular complications

    at baseline visit/study start

  • Percentage of diabetic patients having peripheral vascular disease

    at baseline visit/study start

  • Percentage of diabetic patients having diabetic nephropathy

    at baseline visit/study start

  • Percentage of diabetic patients having diabetic eye complications

    at baseline visit/study start

Secondary Outcomes (4)

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

    at baseline visit/study start

  • 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

    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

Study Arms (1)

A

Other: No treatment given

Interventions

No treatment givenOTHER

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

A

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-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 inclusion and exclusion criteria.

You may qualify if:

  • 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

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Unknown Facility

Manila, 1605, Philippines

Location

Related Links

Biospecimen

Retention: SAMPLES WITH DNA

Capillary or venous blood will be drawn for analysing HbA1c.

MeSH Terms

Conditions

Diabetes MellitusDiabetes Mellitus, Type 1Diabetes Mellitus, Type 2

Condition Hierarchy (Ancestors)

Glucose Metabolism DisordersMetabolic DiseasesNutritional and Metabolic DiseasesEndocrine System DiseasesAutoimmune DiseasesImmune System Diseases

Study Officials

  • Global Clinical Registry (GCR, 1452)

    Novo Nordisk A/S

    STUDY DIRECTOR

Study Design

Study Type
observational
Observational Model
ECOLOGIC OR COMMUNITY
Time Perspective
CROSS SECTIONAL
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

March 31, 2009

First Posted

April 2, 2009

Study Start

April 1, 2009

Primary Completion

October 1, 2009

Study Completion

October 1, 2009

Last Updated

November 2, 2023

Record last verified: 2023-10

Locations

PH(1)