NCT01934686

Brief Summary

This study is conducted in Asia. The aim of this non-interventional study is to evaluate the current status of diabetes management, control, and complications in diabetic subjects in Indonesia.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
1,862

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Sep 2013

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

August 30, 2013

Completed
2 days until next milestone

Study Start

First participant enrolled

September 1, 2013

Completed
3 days until next milestone

First Posted

Study publicly available on registry

September 4, 2013

Completed
6 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 1, 2014

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

March 1, 2014

Completed
Last Updated

May 28, 2014

Status Verified

May 1, 2014

Enrollment Period

6 months

First QC Date

August 30, 2013

Last Update Submit

May 26, 2014

Conditions

Outcome Measures

Primary Outcomes (1)

  • Proportion of patients having HbA1c ((Glycosylated Haemoglobin) as measured during survey) less than 7%

    Evaluated at the first visit (only one study visit)

Secondary Outcomes (8)

  • Mean Postprandial Plasma Glucose (PPG) of patients

    Evaluated at the first visit (only one study visit)

  • Mean HbA1c of patients

    Evaluated at the first visit (only one study visit)

  • Proportion of patients having dyslipidemia

    Evaluated at the first visit (only one study visit)

  • Proportion of patients having hypertension

    Evaluated at the first visit (only one study visit)

  • Proportion of patients having cardiovascular complications

    Evaluated at the first visit (only one study visit)

  • +3 more secondary outcomes

Study Arms (1)

Subjects with diabetes mellitus (type 2)

Other: No treatment given

Interventions

Patients will fill out a questionnaire by interview.

Subjects with diabetes mellitus (type 2)

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

People having been treated for at least a year are eligible for the study. The selection of the patients will be done randomly by the individual physician involved in the study.

You may qualify if:

  • People with type 2 diabetes mellitus (DM) who are being treated, with any of the non-pharmacological or pharmacological options, at a particular centre for at least 1 year and who have visited the centre within the last 3-6 months
  • Patients willing to sign informed consent form

You may not qualify if:

  • Previous participation in this study
  • Unable to comply with protocol requirements
  • Confirmed or suspected pregnancy

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Unknown Facility

Jakarta, 12520, Indonesia

Location

Related Links

MeSH Terms

Conditions

Diabetes MellitusDiabetes Mellitus, Type 2

Condition Hierarchy (Ancestors)

Glucose Metabolism DisordersMetabolic DiseasesNutritional and Metabolic DiseasesEndocrine 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

August 30, 2013

First Posted

September 4, 2013

Study Start

September 1, 2013

Primary Completion

March 1, 2014

Study Completion

March 1, 2014

Last Updated

May 28, 2014

Record last verified: 2014-05

Locations