Management of Dyslipidemia in Adult Type 2 Diabetes Patients in India (SOLID)

This study has been completed.

Sponsor:

Information provided by (Responsible Party):

AstraZeneca

ClinicalTrials.gov Identifier:

NCT01292018

First received: January 31, 2011

Last updated: February 20, 2013

Last verified: February 2013

History of Changes

Tracking Information
First Received Date ^ICMJE	January 31, 2011
Last Updated Date	February 20, 2013
Start Date ^ICMJE	February 2011
Primary Completion Date	Not Provided
Current Primary Outcome Measures ^ICMJE (submitted: February 8, 2011)	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 [ Designated as safety issue: No ]
Original Primary Outcome Measures ^ICMJE	Same as current
Change History	Complete list of historical versions of study NCT01292018 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures ^ICMJE (submitted: February 8, 2011)	Proportion of dyslipidemia control rate according to american diabetes Association (ADA) 2010 criteria by age and gender [ Designated as safety issue: No ] Control of dyslipidemia by Lipid Lowering Drugs (LLDs) drugs alone or combination [ Designated as safety issue: No ] Control of dyslipidemia by all commercial available brands hypolipidemics drugs [ Designated as safety issue: No ]
Original Secondary Outcome Measures ^ICMJE	Same as current
Current Other Outcome Measures ^ICMJE	Not Provided
Original Other Outcome Measures ^ICMJE	Not Provided

Descriptive Information
Brief Title ^ICMJE	Management of Dyslipidemia in Adult Type 2 Diabetes Patients in India
Official Title ^ICMJE	A Non Interventional, Cross Sectional, Epidemiological Study on the Management of Dyslipidemia in Type 2 DM Adult Patients in India
Brief Summary	The purpose of study to assess the control of dyslipidemia in the Indian diabetic population treated with any hypolipidemic agent.
Detailed Description	Not Provided
Study Type ^ICMJE	Observational
Study Design ^ICMJE	Observational Model: Cohort Time Perspective: Cross-Sectional
Target Follow-Up Duration	Not Provided
Biospecimen	Retention: Samples Without DNA Description: Lipid profile ( Low Density Lipoproteins(LDL), High Density Lipoprotein (HDL), Triglycerides & Total cholesterol) Blood Glucose Measurements (Fasting Plasma Glucose)
Sampling Method	Non-Probability Sample
Study Population	Type 2 Diabetics with dyslipidemia on stable dose of Lipid Lowering Drugs(LLDs).
Condition ^ICMJE	Dyslipidemia Type 2 Diabetes Mellitus
Intervention ^ICMJE	Not Provided
Study Group/Cohort (s)	Not Provided
Publications *	Not Provided
* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.

Recruitment Information
Recruitment Status ^ICMJE	Completed
Enrollment ^ICMJE	5400
Completion Date	February 2012
Primary Completion Date	Not Provided
Eligibility Criteria ^ICMJE	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
Gender	Both
Ages	18 Years and older
Accepts Healthy Volunteers	No
Contacts ^ICMJE	Contact information is only displayed when the study is recruiting subjects
Location Countries ^ICMJE	Not Provided

Administrative Information
NCT Number ^ICMJE	NCT01292018
Other Study ID Numbers ^ICMJE	NIS-CIN-DUM-2010/1
Has Data Monitoring Committee	No
Responsible Party	AstraZeneca
Study Sponsor ^ICMJE	AstraZeneca
Collaborators ^ICMJE	Not Provided
Investigators ^ICMJE	Not Provided
Information Provided By	AstraZeneca
Verification Date	February 2013
^ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP

To Top