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

Withdrawn

• Conditions: Diabetes; Diabetes Mellitus, Type 2
• Interventions: Other: No treatment given

• Registration Number: NCT01957592
• Lead Sponsor: Novo Nordisk A/S

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 Sri Lanka.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2013-10-01
• Study First Submitted QC: 2013-10-01
• Study First Posted: 2013-10-08
• Status Verified: 2014-10
• Study Start: 2014-10
• Last Update Submitted: 2014-10-01
• Last Update Posted: 2014-10-02
• Primary Completion: 2014-12
• Study Completion: 2014-12

Recruitment & Eligibility

• Status: WITHDRAWN
• Sex: All
• Target Recruitment: Not specified

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

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Exclusion Criteria

• Previous participation in this study
• Unable to comply with protocol requirements
• Confirmed or suspected pregnancy

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Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Subjects with diabetes mellitus (type 2)	No treatment given	-

Primary Outcome Measures

Name	Time	Method
Proportion of patients having HbA1c ((Glycosylated Haemoglobin) as measured during survey) less than 7%	Evaluated at the first visit (only one study visit)

Secondary Outcome Measures

Name	Time	Method
Mean HbA1c of patients	Evaluated at the first visit (only one study visit)
Proportion of patients having diabetic eye complications	Evaluated at the first visit (only one study visit)
Mean Fasting Plasma Glucose (FPG) of patients	Evaluated at the first visit (only one study visit)
Proportion of patients having dyslipidemia	Evaluated at the first visit (only one study visit)
Proportion of patients having hypertension	Evaluated at the first visit (only one study visit)
Proportion of patients having peripheral vascular disease	Evaluated at the first visit (only one study visit)
Mean Postprandial Plasma Glucose (PPG) of patients	Evaluated at the first visit (only one study visit)
Proportion of patients having cardiovascular complications	Evaluated at the first visit (only one study visit)
Proportion of patients having diabetic nephropathy	Evaluated at the first visit (only one study visit)