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
EudraCT ID
Not applicable
EU CT Number
Not applicable
Trial status
Finalized
Finalized
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
Observational study model:
Other
Primary completion date:
Not applicable
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)
No location data available.
Study documents
No study documents available.
Results overview
No study documents available
Recruitment status
Finalized
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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