NCT01957592

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 Sri Lanka.

Trial Health

15
At Risk

Trial Health Score

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

Trial has exceeded expected completion date
Timeline
Completed

Started Oct 2014

Shorter than P25 for all trials

Status
withdrawn

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

October 1, 2013

Completed
7 days until next milestone

First Posted

Study publicly available on registry

October 8, 2013

Completed
12 months until next milestone

Study Start

First participant enrolled

October 1, 2014

Completed
2 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2014

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2014

Completed
Last Updated

October 2, 2014

Status Verified

October 1, 2014

Enrollment Period

2 months

First QC Date

October 1, 2013

Last Update Submit

October 1, 2014

Conditions

DiabetesDiabetes Mellitus, Type 2

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 (9)

  • Mean Fasting Plasma Glucose (FPG) of patients

    Evaluated at the first visit (only one study visit)

  • 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)

  • +4 more secondary outcomes

Study Arms (1)

Subjects with diabetes mellitus (type 2)

Other: No treatment given

Interventions

No treatment givenOTHER

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

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
0

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

October 1, 2013

First Posted

October 8, 2013

Study Start

October 1, 2014

Primary Completion

December 1, 2014

Study Completion

December 1, 2014

Last Updated

October 2, 2014

Record last verified: 2014-10