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NCT01292018 Clinical Trial

Management of Dyslipidemia in Adult Type 2 Diabetes Patients in India

Type 2 Diabetes Mellitus Clinical Trial

— SOLID  

Official title:
A Non Interventional, Cross Sectional, Epidemiological Study on the Management of Dyslipidemia in Type 2 DM Adult Patients in India

Clinical Trial Details — Status: Completed

Administrative data
NCT number NCT01292018
Other study ID # NIS-CIN-DUM-2010/1
Secondary ID
Status Completed
Phase N/A
First received January 31, 2011
Last updated February 20, 2013
Start date February 2011
Est. completion date February 2012

Study information
Verified date February 2013
Source AstraZeneca
Contact n/a
Is FDA regulated No
Health authority India: Drugs Controller General of India
Study type Observational

Clinical Trial Summary

The purpose of study to assess the control of dyslipidemia in the Indian diabetic population treated with any hypolipidemic agent.

Recruitment information / eligibility
Status Completed
Enrollment 5400
Est. completion date February 2012
Est. primary completion date
Accepts healthy volunteers No
Gender Both
Age group 18 Years and older
Eligibility Inclusion Criteria:

- Adult who is a known Type 2 diabetic as per the ADA 2010 criteria OR controlled diabetic (taking any antidiabetic medication)

- Patients in the study will have been on lipid lowering drugs at a stable dose for the last three months before the designated study visit.

Exclusion Criteria:

- Type 1 diabetic patients

- Patients with a history of hepatic or renal diseases

- Hypertension due to organic diseases

Study Design

Observational Model: Cohort, Time Perspective: Cross-Sectional

Related Conditions & MeSH terms

Locations
Country Name City State
n/a

Sponsors (1)
Lead Sponsor Collaborator
AstraZeneca

Outcome
Type Measure Description Time frame Safety issue
Primary Proportion of type 2 diabetic dyslipidemia patients achieving the target LDL goal according to ADA 2010. These patients should be on stable dose of Lipid Lowering Drugs(LDL) for at least 3 months No
Secondary Proportion of dyslipidemia control rate according to american diabetes Association (ADA) 2010 criteria by age and gender No
Secondary Control of dyslipidemia by Lipid Lowering Drugs (LLDs) drugs alone or combination No
Secondary Control of dyslipidemia by all commercial available brands hypolipidemics drugs No
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