Clinical trial NCT02066766: A Cross-Sectional Survey to Evaluate Diabetes Management, Control, Complications, Psychosocial Aspects of Patients With Type 2 Diabetes in Bangladesh, Indonesia, Malaysia, Philippines, Sri Lanka and Vietnam
Official title: A Cross-Sectional Survey to Evaluate Diabetes Management, Control, Complications, Psychosocial Aspects of Patients With Type 2 Diabetes in Bangladesh, Indonesia, Malaysia, Philippines, Sri Lanka and Vietnam
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Diabetes
Diabetes Mellitus, Type 2
Lead sponsor: Novo Nordisk A/S
Sponsor class: INDUSTRY
First posted: 2014-02-20
Enrollment: 1631
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: ECOLOGIC_OR_COMMUNITY
Time perspective: CROSS_SECTIONAL
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.

Brief summary: 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 Vietnam.


Eligibility 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

Primary outcomes:
measure: Proportion of patients having HbA1c ((Glycosylated Haemoglobin) as measured during survey) less than 7%
timeFrame: Evaluated at the first visit (only one study visit)
Secondary outcomes:
measure: Mean Fasting Plasma Glucose (FPG) of patients
timeFrame: Evaluated at the first visit (only one study visit)
measure: Mean Postprandial Plasma Glucose (PPG) of patients
timeFrame: Evaluated at the first visit (only one study visit)
measure: Mean HbA1c of patients
timeFrame: Evaluated at the first visit (only one study visit)
measure: Proportion of patients having dyslipidemia
timeFrame: Evaluated at the first visit (only one study visit)
measure: Proportion of patients having hypertension
timeFrame: Evaluated at the first visit (only one study visit)
measure: Proportion of patients having cardiovascular complications
timeFrame: Evaluated at the first visit (only one study visit)
measure: Proportion of patients having peripheral vascular disease
timeFrame: Evaluated at the first visit (only one study visit)
measure: Proportion of patients having diabetic nephropathy
timeFrame: Evaluated at the first visit (only one study visit)
measure: Proportion of patients having diabetic eye complications
timeFrame: Evaluated at the first visit (only one study visit)
Other outcomes:
Locations:
city: Hanoi
country: Vietnam
facility: Novo Nordisk Investigational Site
Study officials:
affiliation: Novo Nordisk A/S
name: Global Clinical Registry (GCR, 1452)
role: STUDY_DIRECTOR
References:
citation: Nguyen KT, Diep BTT, Nguyen VKD, Lam HV, Tran KQ, Tran NQ. A cross-sectional study to evaluate diabetes management, control and complications in 1631 patients with type 2 diabetes mellitus in Vietnam (DiabCare Asia). Int J Diabetes Dev Ctries 2019 [Epub ahead of print] DOI: 10.1007/s13410-019-00755-w