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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This study has been withdrawn prior to enrollment.
Sponsor:
Information provided by (Responsible Party):
Novo Nordisk A/S
ClinicalTrials.gov Identifier:
NCT01957592
First received: October 1, 2013
Last updated: October 1, 2014
Last verified: October 2014
  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 ]

Enrollment: 0
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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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

Sponsors and Collaborators
Novo Nordisk A/S
Investigators
Study Director: Global Clinical Registry (GCR, 1452) Novo Nordisk A/S
  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 1, 2014
Health Authority: Sri Lanka: Ministry of Health

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

ClinicalTrials.gov processed this record on November 25, 2014