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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT01292018
Recruitment Status : Completed
First Posted : February 9, 2011
Last Update Posted : February 21, 2013
Information provided by (Responsible Party):

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

Condition or disease
Dyslipidemia Type 2 Diabetes Mellitus

Study Type : Observational
Actual Enrollment : 5400 participants
Observational Model: Cohort
Time Perspective: Cross-Sectional
Official Title: A Non Interventional, Cross Sectional, Epidemiological Study on the Management of Dyslipidemia in Type 2 DM Adult Patients in India
Study Start Date : February 2011
Actual Study Completion Date : February 2012

Resource links provided by the National Library of Medicine

U.S. FDA Resources

Primary Outcome Measures :
  1. 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

Secondary Outcome Measures :
  1. Proportion of dyslipidemia control rate according to american diabetes Association (ADA) 2010 criteria by age and gender
  2. Control of dyslipidemia by Lipid Lowering Drugs (LLDs) drugs alone or combination
  3. Control of dyslipidemia by all commercial available brands hypolipidemics drugs

Biospecimen Retention:   Samples Without DNA
Lipid profile ( Low Density Lipoproteins(LDL), High Density Lipoprotein (HDL), Triglycerides & Total cholesterol) Blood Glucose Measurements (Fasting Plasma Glucose)

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.

Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
Type 2 Diabetics with dyslipidemia on stable dose of Lipid Lowering Drugs(LLDs).

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

Responsible Party: AstraZeneca Identifier: NCT01292018     History of Changes
Other Study ID Numbers: NIS-CIN-DUM-2010/1
First Posted: February 9, 2011    Key Record Dates
Last Update Posted: February 21, 2013
Last Verified: February 2013

Keywords provided by AstraZeneca:
Management of dyslipidemia in Type 2 Diabetes Mellitus adult patients in India
Dyslipidemia control rates in Type 2 diabetic Mellitus patients

Additional relevant MeSH terms:
Diabetes Mellitus
Diabetes Mellitus, Type 2
Glucose Metabolism Disorders
Metabolic Diseases
Endocrine System Diseases
Lipid Metabolism Disorders