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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
  Purpose

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


Condition
Dyslipidemia
Type 2 Diabetes Mellitus

Study Type: Observational
Study Design: 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

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by AstraZeneca:

Primary Outcome Measures:
  • 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 ]

Secondary Outcome Measures:
  • 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 ]

Biospecimen Retention:   Samples Without DNA

Lipid profile ( Low Density Lipoproteins(LDL), High Density Lipoprotein (HDL), Triglycerides & Total cholesterol) Blood Glucose Measurements (Fasting Plasma Glucose)


Enrollment: 5400
Study Start Date: February 2011
Study Completion Date: February 2012
  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population

Type 2 Diabetics with dyslipidemia on stable dose of Lipid Lowering Drugs(LLDs).

Criteria

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
  Contacts and Locations
No Contacts or Locations Provided
  More Information

No publications provided

Responsible Party: AstraZeneca
ClinicalTrials.gov Identifier: NCT01292018     History of Changes
Other Study ID Numbers: NIS-CIN-DUM-2010/1
Study First Received: January 31, 2011
Last Updated: February 20, 2013
Health Authority: India: Drugs Controller General of India

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
Dyslipidemias
Glucose Metabolism Disorders
 Metabolic Diseases
Endocrine System Diseases
Lipid Metabolism Disorders

ClinicalTrials.gov processed this record on May 19, 2013