Last updated: 11/03/2018 08:05:19

Epidemiologic survey to describe the current medical practice of general practitioners treating subjects with type 2 diabetes mellitus in LatinaDEAL

GSK study ID
105407
Clinicaltrials.gov ID
NCT01387165
EudraCT ID
Not applicable
EU CT Number
Not applicable
Trial status
Study complete
Study complete
Overview
Eligibility
Locations
Study documents
Results summary
Plain language summaries
Additional information

Trial overview

Official title: A multi-center, epidemiologic survey to describe the current medical practice of general practitioners treating subjects with type 2 diabetes mellitus in Latin America
Trial description: The DEAL (Diabetes En America Latina) study was a multicenter, cross-sectional, epidemiological, questionnaire based study carried out between October 2004 and October 2005 in 9 Latin American countries.
Primary purpose:
Not applicable
Trial design:
Not applicable
Masking:
Not applicable
Allocation:
Not applicable
Primary outcomes:

The achievement of the planned completed number of questionnaires.

Timeframe: up to 1 year

Secondary outcomes:

Changes in glycemic parameters in accordance with the historical information provided by the GPs and her/his judgement of control based on that information.

Timeframe: up to 1 year

Proportion of subjects who respond to any given treatment applied through the level of HbA1c responders (defined as subjects who have achieved HbA1c <7%)

Timeframe: up to 1 year

Assessment of total cholesterol

Timeframe: up to 1 year

Assessment of free fatty acids

Timeframe: up to 1 year

Assessment of high-density lipoprotein

Timeframe: up to 1 year

Assessment low-density lipoprotein

Timeframe: up to 1 year

Assessment of triglycerides

Timeframe: up to 1 year

Assessment of LDL relative flotation

Timeframe: up to 1 year

Assessment of total cholesterol/HDL ratio

Timeframe: up to 1 year

Assessment of LDL/HDL ratio

Timeframe: up to 1 year

Assessment of fasting blood glucose

Timeframe: up to 1 year

Interventions:
  • Drug: Treatment
    • Enrollment:
    3592
    Primary completion date:
    Not applicable
    Observational study model:
    Other
    Time perspective:
    Cross-Sectional
    Clinical publications:
    Not applicable
    Medical condition
    Diabetes Mellitus, Type 2
    Product
    rosiglitazone
    Collaborators
    GSK
    Study date(s)
    October 2004 to September 2005
    Type
    Observational
    Phase
    Not applicable

    Participation criteria

    Sex
    Female & Male
    Age
    18 - 75 years
    Accepts healthy volunteers
    No
    • Inclusion Criteria:
    • Males and females 18-75 years of age, inclusive,
    Inclusion and exclusion criteria
    Inclusion criteria:
    • Inclusion Criteria:
    • Males and females 18-75 years of age, inclusive,
    • Males and females with T2DM, as defined by the criteria of the American Diabetes Association (2003),
    • Males and females under oral anti-diabetics (OAD) or insulin treatment for diabetes and
    • Males and females that have given written informed consent.

    Trial location(s)

    This study does not involve prospective enrollment of participants.

    Study documents

    No study documents available.

    Results overview

    No study documents available

    Recruitment status
    Study complete
    Actual primary completion date
    Not applicable
    Actual study completion date
    2005-04-09

    Plain language summaries

    Not applicable. GSK’s transparency policy provides for Plain Language Summaries for Interventional studies.

    Additional information about the trial

    Participate in clinical trial
    Additional information
    Control of type 2 diabetes mellitus among general practitioners in private practice in nine countries of Latin America
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    Access to clinical trial data by researchers
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