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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT01877200
Other study ID # INS-4071
Secondary ID U1111-1137-2729
Status Completed
Phase N/A
First received June 11, 2013
Last updated January 20, 2015
Start date June 2013
Est. completion date September 2013

Study information

Verified date January 2015
Source Novo Nordisk A/S
Contact n/a
Is FDA regulated No
Health authority Bangladesh: Ministry of Health
Study type Observational

Clinical Trial 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.


Recruitment information / eligibility

Status Completed
Enrollment 2092
Est. completion date September 2013
Est. primary completion date September 2013
Accepts healthy volunteers No
Gender Both
Age group 18 Years and older
Eligibility Inclusion Criteria:

- 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

Exclusion Criteria:

- Previous participation in this study

- Unable to comply with protocol requirements

- Confirmed or suspected pregnancy

Study Design

Observational Model: Ecologic or Community, Time Perspective: Cross-Sectional


Related Conditions & MeSH terms


Intervention

Other:
No treatment given
Patients will fill out a questionnaire by interview.

Locations

Country Name City State
n/a

Sponsors (1)

Lead Sponsor Collaborator
Novo Nordisk A/S

Country where clinical trial is conducted

Bangladesh, 

Outcome

Type Measure Description Time frame Safety issue
Primary Proportion of patients having HbA1c ((Glycosylated Haemoglobin) as measured during survey) less than 7% Evaluated at the first visit (only one study visit) No
Secondary Mean Fasting Plasma Glucose (FPG) of patients Evaluated at the first visit (only one study visit) No
Secondary Mean Postprandial Plasma Glucose (PPG) of patients Evaluated at the first visit (only one study visit) No
Secondary Mean HbA1c of patients Evaluated at the first visit (only one study visit) No
Secondary Proportion of patients having dyslipidemia and hypertension Evaluated at the first visit (only one study visit) No
Secondary Proportion of patients having cardiovascular complications Evaluated at the first visit (only one study visit) No
Secondary Proportion of patients having peripheral vascular disease Evaluated at the first visit (only one study visit) No
Secondary Proportion of patients having diabetic nephropathy Evaluated at the first visit (only one study visit) No
Secondary Proportion of patients having diabetic eye complications Evaluated at the first visit (only one study visit) No
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