DyslipidemiaSOLIDNCT01292018
Management of Dyslipidemia in Adult Type 2 Diabetes Patients in India
An observational study of Dyslipidemia and Type 2 Diabetes Mellitus, run by AstraZeneca.
Trial summary
The purpose of study to assess the control of dyslipidemia in the Indian diabetic population treated with any hypolipidemic agent. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Dyslipidemia, Type 2 Diabetes Mellitus
- How many people
- 5,400 participants
- Where
- No sites listed yet
- Study dates
- Feb 2011to Feb 2012
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Type 2 Diabetics with dyslipidemia on stable dose of Lipid Lowering Drugs(LLDs).
Who may be able to join
- 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.
Who cannot join
- Type 1 diabetic patients
- Patients with a history of hepatic or renal diseases
- Hypertension due to organic diseases
About this study
Official title: A Non Interventional, Cross Sectional, Epidemiological Study on the Management of Dyslipidemia in Type 2 DM Adult Patients in India
The purpose of study to assess the control of dyslipidemia in the Indian diabetic population treated with any hypolipidemic agent.
- Conditions
- Dyslipidemia, Type 2 Diabetes Mellitus
- Keywords
- Management of dyslipidemia in Type 2 Diabetes Mellitus adult patients in India, Dyslipidemia control rates in Type 2 diabetic Mellitus patients
- Medical subject headings
- Dyslipidemias, Diabetes Mellitus, Type 2
What is being measured
The primary outcome is the main question the study is designed to answer.
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 outcomes (3)
Proportion of dyslipidemia control rate according to american diabetes Association (ADA) 2010 criteria by age and gender
Control of dyslipidemia by Lipid Lowering Drugs (LLDs) drugs alone or combination
Control of dyslipidemia by all commercial available brands hypolipidemics drugs
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Feb 2011 (estimated)
- Study startFeb 2011
- Study completionFeb 2012
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for DyslipidemiaStudies of the same condition, open and under way.
- More trials run by AstraZenecaThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Cross-sectional
- Enrolment
- 5,400 participants (actual)
Sponsor and investigators
- Lead sponsor
- AstraZeneca
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01292018
- Sponsor's protocol ID
- NIS-CIN-DUM-2010/1
- Acronym
- SOLID
- Status last verified
- Feb 2013
- First submitted
- 31 Jan 2011
- Last updated
- 21 Feb 2013
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 21 Feb 2013. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Non Interventional, Cross Sectional, Epidemiological Study on the Management of Dyslipidemia in Type 2 DM Adult Patients in India
- ClinicalTrials.gov ID
- NCT01292018
- Acronym / sponsor ID
- SOLID / NIS-CIN-DUM-2010/1
- Conditions
- Dyslipidemia, Type 2 Diabetes Mellitus
- Keywords
- Management of dyslipidemia in Type 2 Diabetes Mellitus adult patients in India, Dyslipidemia control rates in Type 2 diabetic Mellitus patients
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 5,400 participants (actual)
- Lead sponsor
- AstraZenecaIndustry (pharma, biotech, devices)
- Study start
- Feb 2011
- Study completion
- Feb 2012 (actual)
- First posted
- 9 Feb 2011 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The purpose of study to assess the control of dyslipidemia in the Indian diabetic population treated with any hypolipidemic agent.
Study design
- Observational model
- Cohort
- Time perspective
- Cross-sectional
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Type 2 Diabetics with dyslipidemia on stable dose of Lipid Lowering Drugs(LLDs).
Key inclusion criteria (2 listed)
- 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.
Key exclusion criteria (3 listed)
- Type 1 diabetic patients
- Patients with a history of hepatic or renal diseases
- Hypertension due to organic diseases
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
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
3 secondary outcomes
Proportion of dyslipidemia control rate according to american diabetes Association (ADA) 2010 criteria by age and gender
Control of dyslipidemia by Lipid Lowering Drugs (LLDs) drugs alone or combination
Control of dyslipidemia by all commercial available brands hypolipidemics drugs
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 21 Feb 2013.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
Questions about this trial
What is this clinical trial studying?
An observational study of Dyslipidemia and Type 2 Diabetes Mellitus, run by AstraZeneca.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 21 Feb 2013. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 21 Feb 2013.