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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT00874159
Other study ID # INS-3712
Secondary ID
Status Completed
Phase
First received
Last updated
Start date April 2009
Est. completion date October 2009

Study information

Verified date October 2023
Source Novo Nordisk A/S
Contact n/a
Is FDA regulated No
Health authority
Study type Observational

Clinical Trial Summary

This study is conducted in Asia. The aim of this observational study is to describe the diabetes management, control status and complication profile in a diabetic population of Philippines.


Recruitment information / eligibility

Status Completed
Enrollment 770
Est. completion date October 2009
Est. primary completion date October 2009
Accepts healthy volunteers No
Gender All
Age group 18 Years and older
Eligibility Inclusion Criteria: - Diabetic patients registered in the particular centre for more than 12 months - Patients should have visited the centre at least once in the last 3-6 months apart from the initial visit - Patients willing to sign informed consent form Exclusion Criteria: - Repetition of any patient as patients should not be included twice for any reason - Unwilling to participate or unable to comply with protocol requirements

Study Design


Intervention

Other:
No treatment given
Subject will only fill out a questionaire when entering the observational study.

Locations

Country Name City State
n/a

Sponsors (1)

Lead Sponsor Collaborator
Novo Nordisk A/S

Country where clinical trial is conducted

Philippines, 

Outcome

Type Measure Description Time frame Safety issue
Primary Mean age of onset of type 1 diabetes mellitus at baseline visit/study start
Primary Mean age of onset of type 2 diabetes mellitus at baseline visit/study start
Primary Mean duration of treatment of type 2 DM at baseline visit/study start
Primary Percentage of patients on Insulin therapy at baseline visit/study start
Primary Percentage of patients on OAD therapy at baseline visit/study start
Primary Mean duration of diabetes in type 1 and type 2 patients respectively at baseline visit/study start
Primary Mean FPG of diabetic patients at baseline visit/study start
Primary Mean PPG of diabetic patients at baseline visit/study start
Primary Mean HbA1c of diabetic patients at baseline visit/study start
Primary Percentage of diabetic patients with HbA1c target below 7.0% at baseline visit/study start
Primary Percentage of diabetic patients with HbA1c target below 6.5% at baseline visit/study start
Primary Percentage of diabetic patients having dyslipidemia and hypertension at baseline visit/study start
Primary Percentage of diabetic patients having cardiovascular complications at baseline visit/study start
Primary Percentage of diabetic patients having peripheral vascular disease at baseline visit/study start
Primary Percentage of diabetic patients having diabetic nephropathy at baseline visit/study start
Primary Percentage of diabetic patients having diabetic eye complications at baseline visit/study start
Secondary Patients' perception will be analysed through Patient questionnaire measuring: Psychological well-being, Quality of life, Patients' compliant to treatment at baseline visit/study start
Secondary Physician perception of diabetes and its management will be analysed through Physician questionnaire measuring awareness about:o HbA1c test and its goal,Anti-diabetic treatment,Barriers towards optimum diabetes control at baseline visit/study start
Secondary Duration of diabetes associated with highest number of diabetic complications at baseline visit/study start
Secondary Minimum duration of diabetes associated with 10% incidence of diabetic complications (CVD, nephropathy and retinopathy) at baseline visit/study start
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