A Cross-Sectional Survey to Evaluate Diabetes Management, Control, Complications, Psychosocial Aspects of Patients With Type 2 Diabetes in Sri Lanka (DiabCare Asia)

This study is not yet open for participant recruitment.
Verified October 2013 by Novo Nordisk A/S
Sponsor:
Information provided by (Responsible Party):
Novo Nordisk A/S
ClinicalTrials.gov Identifier:
NCT01957592
First received: October 1, 2013
Last updated: October 25, 2013
Last verified: October 2013
  Purpose

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.


Condition Intervention
Diabetes
Diabetes Mellitus, Type 2
Other: No treatment given

Study Type: Observational
Study Design: Observational Model: Ecologic or Community
Time Perspective: Cross-Sectional
Official Title: A Cross-Sectional Survey to Evaluate Diabetes Management, Control, Complications, Psychosocial Aspects of Patients With Type 2 Diabetes in Sri Lanka

Resource links provided by NLM:


Further study details as provided by Novo Nordisk A/S:

Primary Outcome Measures:
  • Proportion of patients having HbA1c ((Glycosylated Haemoglobin) as measured during survey) less than 7% [ Time Frame: Evaluated at the first visit (only one study visit) ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Mean Fasting Plasma Glucose (FPG) of patients [ Time Frame: Evaluated at the first visit (only one study visit) ] [ Designated as safety issue: No ]
  • Mean Postprandial Plasma Glucose (PPG) of patients [ Time Frame: Evaluated at the first visit (only one study visit) ] [ Designated as safety issue: No ]
  • Mean HbA1c of patients [ Time Frame: Evaluated at the first visit (only one study visit) ] [ Designated as safety issue: No ]
  • Proportion of patients having dyslipidemia [ Time Frame: Evaluated at the first visit (only one study visit) ] [ Designated as safety issue: No ]
  • Proportion of patients having hypertension [ Time Frame: Evaluated at the first visit (only one study visit) ] [ Designated as safety issue: No ]
  • Proportion of patients having cardiovascular complications [ Time Frame: Evaluated at the first visit (only one study visit) ] [ Designated as safety issue: No ]
  • Proportion of patients having peripheral vascular disease [ Time Frame: Evaluated at the first visit (only one study visit) ] [ Designated as safety issue: No ]
  • Proportion of patients having diabetic nephropathy [ Time Frame: Evaluated at the first visit (only one study visit) ] [ Designated as safety issue: No ]
  • Proportion of patients having diabetic eye complications [ Time Frame: Evaluated at the first visit (only one study visit) ] [ Designated as safety issue: No ]

Estimated Enrollment: 669
Study Start Date: October 2014
Estimated Study Completion Date: December 2014
Estimated Primary Completion Date: December 2014 (Final data collection date for primary outcome measure)
Groups/Cohorts Assigned Interventions
Subjects with diabetes mellitus (type 2) Other: No treatment given
Patients will fill out a questionnaire by interview.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Sampling Method:   Non-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.

Criteria

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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01957592

Contacts
Contact: Novo Nordisk clinicaltrials@novonordisk.com

Locations
Sri Lanka
Not yet recruiting
Bangalore, Sri Lanka, 560001
Sponsors and Collaborators
Novo Nordisk A/S
Investigators
Study Director: Prasanna Kumar Novo Nordisk Ltd.
  More Information

Additional Information:
No publications provided

Responsible Party: Novo Nordisk A/S
ClinicalTrials.gov Identifier: NCT01957592     History of Changes
Other Study ID Numbers: INS-4068, U1111-1138-8495
Study First Received: October 1, 2013
Last Updated: October 25, 2013
Health Authority: Sri Lanka: Ministry of Health

Additional relevant MeSH terms:
Diabetes Mellitus
Diabetes Mellitus, Type 2
Glucose Metabolism Disorders
Metabolic Diseases
Endocrine System Diseases

ClinicalTrials.gov processed this record on April 16, 2014