Now Available for Public Comment: Notice of Proposed Rulemaking (NPRM) for FDAAA 801 and NIH Draft Reporting Policy for NIH-Funded Trials

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This study has been withdrawn prior to enrollment.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

October 1, 2013
October 1, 2014
October 2014
December 2014   (final data collection date for primary outcome measure)
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 ]
Same as current
Complete list of historical versions of study NCT01957592 on ClinicalTrials.gov Archive Site
  • 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 ]
Same as current
Not Provided
Not Provided
 
A Cross-Sectional Survey to Evaluate Diabetes Management, Control, Complications, Psychosocial Aspects of Patients With Type 2 Diabetes in Sri Lanka
A Cross-Sectional Survey to Evaluate Diabetes Management, Control, Complications, Psychosocial Aspects of Patients With Type 2 Diabetes in Sri Lanka

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.

Not Provided
Observational
Observational Model: Ecologic or Community
Time Perspective: Cross-Sectional
Not Provided
Not Provided
Non-Probability Sample

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.

  • Diabetes
  • Diabetes Mellitus, Type 2
Other: No treatment given
Patients will fill out a questionnaire by interview.
Subjects with diabetes mellitus (type 2)
Intervention: Other: No treatment given
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Withdrawn
0
December 2014
December 2014   (final data collection date for primary outcome measure)

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
Both
18 Years and older
No
Contact information is only displayed when the study is recruiting subjects
Not Provided
 
NCT01957592
INS-4068, U1111-1138-8495
No
Novo Nordisk A/S
Novo Nordisk A/S
Not Provided
Study Director: Global Clinical Registry (GCR, 1452) Novo Nordisk A/S
Novo Nordisk A/S
October 2014

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP