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
  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:


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
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, see Learn About Clinical Studies.

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 September 18, 2014