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CompletedNCT01387165DEALUpdated Jun 8, 2017

Epidemiologic Survey to Describe the Current Medical Practice of General Practitioners Treating Subjects With Type 2 Diabetes Mellitus in Latina

An observational study in Diabetes Mellitus, Type 2, sponsored by GlaxoSmithKline. Completed. Open to participants aged 18 Years to 75 Years. Per ClinicalTrials.gov, last updated 2017-06-08.

Sponsored by GlaxoSmithKline · Observational

Study type
Observational
Model
Other
Time perspective
Cross-sectional
Enrollment
3,592
Ages
18 Years to 75 Years
Sex
All
01

Study summary

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.

Read the detailed 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. General practitioners (GP) from private settings were selected for participation in the study if they were in full time active clinical practice (three or more days per week and treating at least 100 patients per week), had been practicing for at least two years and were seeing at least five type 2 diabetes mellitus (T2DM) patients per week. Over a period of two weeks after receipt of study questionnaires, GPs were required to review the charts of the first 10 (+/- 2) consecutive diabetic patients to visit the clinic and to provide information about their treatment in accordance with the supplied questionnaire.

Patients were eligible for inclusion in the study if they were males or females aged 18-75 with Type II Diabetes Mellitus - T2DM - (defined by the criteria of the American Diabetes Association (12)), were receiving an oral hypoglycemic agent (OHA) or insulin and had given written informed consent, where required. Measurement of glycosylated hemoglobin (HbA1c) performed at the diagnosis and within the previous three months was collected; if the measure was not available for the period, the sponsor supported the laboratory test when necessary, according to the physician's judgment of the patient's need.

Demographic data were collected including information regarding the patient's lifestyle. The most recent fasting blood glucose, lipid level and blood pressure measurements were recorded along with the existence of diabetes related complications such as dyslipidemia, hypertension, macrovascular diseases, eye disorders, kidney disorders, erectile dysfunction and diabetic neuropathy. Antidiabetic medication and/or insulin therapy and therapy for prevention of macrovascular events were also recorded. Information was collected on visits to specialists, challenges to managing the patient's T2DM and on future plans for management. No explanations or clarifications related to the questions were provided and the physicians answered them based on their own understanding. Instructions on how to answer the questionnaire were provided to maximize the validation of the questionnaires.

Descriptive statistical analysis was performed on all variables. Multivariate logistic regression analyses were performed to test the possibility of association between the outcome measures and duration of disease. The independent variables were age, gender, BMI (body-mass index) category, current prescription, drug insurance coverage, glycemic management, lifestyle, number of co-morbidities and compliance to recommendations/therapy. All statistical analyses were conducted using SAS software. A p value \<0.05 was considered statistically significant.

02

Conditions studied

  • Diabetes Mellitus, Type 2

Keywords

  • Latin America
  • diabetes complications
  • patient compliance
  • Diabetes mellitus, type 2
  • health services accessibility
03

In context

Diabetes Mellitus

10,925 studies on the registry are indexed under Diabetes Mellitus; 1,319 are open to participants now.

This study's enrollment of 3,592 is above the median of 233 across 2,220 observational studies indexed under Diabetes Mellitus.

Browse Diabetes Mellitus studies →

Lead sponsor

GlaxoSmithKline is the lead sponsor of 3,562 studies on the registry; 117 are open to participants now.

Of its 258 completed or terminated interventional studies of FDA-regulated products, 232 (90%) have results posted.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years to 75 Years
Sexes eligible
All
Accepts healthy volunteers
No
Sampling method
Probability sample

Study population

Males and females 18-75 years of age, inclusive, with T2DM, as defined by the criteria of the American Diabetes Association (2003), under oral anti-diabetics (OAD) or insulin treatment for diabetes and that have given written informed consent.

The total number of patients planned for this study was up to 6,000 patients: Mexico - 1,500, Argentina - 1,000, Brazil - 1,500, CariCam - 1,100 (Colombia, Costa Rica, Ecuador, Guatemala, Honduras, Peru, Dominican Republic and Venezuela) and Chile - 500.

Eligibility 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.
05

Study design

Observational model
Other
Time perspective
Cross-sectional
Enrollment
3,592 participants (actual)

Groups and cohorts

  • Patients

    males and females between 18 and 75 years of age who been diagnosed with T2DM as defined by the American Diabetes Association

    Drug: Treatment

Interventions

  • DrugTreatment

    were receiving an oral hypoglycemic agent (OHA) or insulin

06

What researchers measure

Primary outcomes

  1. The achievement of the planned completed number of questionnaires.

    Time frame: up to 1 year

Secondary outcomes

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

    Time frame: up to 1 year

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

    Time frame: up to 1 year

  3. Assessment of total cholesterol

    Time frame: up to 1 year

  4. Assessment of free fatty acids

    Time frame: up to 1 year

  5. Assessment of high-density lipoprotein

    Time frame: up to 1 year

  6. Assessment low-density lipoprotein

    Time frame: up to 1 year

  7. Assessment of triglycerides

    Time frame: up to 1 year

  8. Assessment of LDL relative flotation

    Time frame: up to 1 year

  9. Assessment of total cholesterol/HDL ratio

    Time frame: up to 1 year

  10. Assessment of LDL/HDL ratio

    Time frame: up to 1 year

  11. Assessment of fasting blood glucose

    Time frame: up to 1 year

07

Study locations

No study locations are listed for this record.

08

References and documents

09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Jun 8, 2017, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT01387165
Lead sponsor
GlaxoSmithKline
Responsible party
Sponsor
First posted
Jul 4, 2011
Start date
Oct 2004
Primary completion
Oct 2005
Completion
Oct 2005
Last update
Jun 8, 2017

Study contacts

GSK Clinical Trials
study director · GlaxoSmithKline

Oversight

Data monitoring committee
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in May 2017. You cannot join it, but the record below documents what was studied.

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