NCT00805922

Brief Summary

This study is conducted in Asia. The aim of this observational study is to evaluate current status of diabetes management, control, complications in diabetic subjects in Thailand.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
2,342

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Dec 2008

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

Study Start

First participant enrolled

December 1, 2008

Completed
8 days until next milestone

First Submitted

Initial submission to the registry

December 9, 2008

Completed
1 day until next milestone

First Posted

Study publicly available on registry

December 10, 2008

Completed
9 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 1, 2009

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

September 1, 2009

Completed
Last Updated

November 22, 2016

Status Verified

November 1, 2016

Enrollment Period

9 months

First QC Date

December 9, 2008

Last Update Submit

November 21, 2016

Conditions

Outcome Measures

Primary Outcomes (1)

  • Mean blood glucose parameters of diabetic patients

    Study start

Secondary Outcomes (4)

  • Patients' perception will be analysed through patient questionnaire measuring psychological well-being, quality of life and patients' compliant to treatment

    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 and barriers towards optimum diabetes control

    Study start

  • Duration of diabetes associated with highest number of diabetic complications

    Study start

  • Minimum duration of diabetes associated with 10% incidence of diabetic complications (CVD, Nephropathy and retinopathy)

    Study start

Study Arms (1)

A

Other: No treatment given

Interventions

Capillary or venous blood will be drawn for analysing HbA1c.

A

Eligibility Criteria

Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

Patients with diabetes mellitus being treated at general hospitals, diabetes clinics and referral clinics will be selected according to the 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)

Novo Nordisk Investigational Site

Bangkok, 10500, Thailand

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

December 9, 2008

First Posted

December 10, 2008

Study Start

December 1, 2008

Primary Completion

September 1, 2009

Study Completion

September 1, 2009

Last Updated

November 22, 2016

Record last verified: 2016-11

Locations