NCT01877200

Brief Summary

This study is conducted in Asia. The aim of this non-interventional study is to evaluate the the current status of diabetes management, control, and complications in diabetic subjects with type 2 diabetes in Bangladesh.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
2,092

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Jun 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

Study Start

First participant enrolled

June 1, 2013

Completed
10 days until next milestone

First Submitted

Initial submission to the registry

June 11, 2013

Completed
2 days until next milestone

First Posted

Study publicly available on registry

June 13, 2013

Completed
3 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 1, 2013

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

September 1, 2013

Completed
Last Updated

January 21, 2015

Status Verified

January 1, 2015

Enrollment Period

3 months

First QC Date

June 11, 2013

Last Update Submit

January 20, 2015

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 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 and 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 (type 2)

Other: No treatment given

Interventions

Patients will fill out a questionnaire by interview.

Subjects with diabetes (type 2)

Eligibility Criteria

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

People 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

Dhaka, 1206, Bangladesh

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

June 11, 2013

First Posted

June 13, 2013

Study Start

June 1, 2013

Primary Completion

September 1, 2013

Study Completion

September 1, 2013

Last Updated

January 21, 2015

Record last verified: 2015-01

Locations