Type 2 Diabetes Mellitus Clinical Trial
— SOLIDOfficial title:
A Non Interventional, Cross Sectional, Epidemiological Study on the Management of Dyslipidemia in Type 2 DM Adult Patients in India
Verified date | February 2013 |
Source | AstraZeneca |
Contact | n/a |
Is FDA regulated | No |
Health authority | India: Drugs Controller General of India |
Study type | Observational |
The purpose of study to assess the control of dyslipidemia in the Indian diabetic population treated with any hypolipidemic agent.
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 |
Observational Model: Cohort, Time Perspective: Cross-Sectional
Country | Name | City | State |
---|---|---|---|
n/a |
Lead Sponsor | Collaborator |
---|---|
AstraZeneca |
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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