NCT00836030

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.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
854

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Jan 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

Study Start

First participant enrolled

January 1, 2009

Completed
29 days until next milestone

First Submitted

Initial submission to the registry

January 30, 2009

Completed
5 days until next milestone

First Posted

Study publicly available on registry

February 4, 2009

Completed
2 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 1, 2009

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

April 1, 2009

Completed
Last Updated

November 22, 2016

Status Verified

November 1, 2016

Enrollment Period

3 months

First QC Date

January 30, 2009

Last Update Submit

November 21, 2016

Conditions

DiabetesDiabetes Mellitus, Type 1Diabetes Mellitus, Type 2

Outcome Measures

Primary Outcomes (13)

  • Mean age of onset of type 1 and 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 and 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 and 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 or equal to 7.0%

    at baseline visit/study start

  • Percentage of diabetic patients with HbA1c target below or equal to 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 - 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

No treatment given

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 (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.

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

Singapore, 307684, Singapore

Location

Related Links

Biospecimen

Retention: SAMPLES WITH DNA

Blood sample

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

January 30, 2009

First Posted

February 4, 2009

Study Start

January 1, 2009

Primary Completion

April 1, 2009

Study Completion

April 1, 2009

Last Updated

November 22, 2016

Record last verified: 2016-11

Locations

SG(1)