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

This study has been completed.
Sponsor:
Information provided by:
GlaxoSmithKline
ClinicalTrials.gov Identifier:
NCT01387165
First received: April 14, 2011
Last updated: June 30, 2011
Last verified: June 2011
  Purpose

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.


Condition Intervention
Diabetes Mellitus, Type 2
Drug: Treatment

Study Type: Observational
Study Design: Time Perspective: Cross-Sectional
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

Resource links provided by NLM:


Further study details as provided by GlaxoSmithKline:

Primary Outcome Measures:
  • The achievement of the planned completed number of questionnaires. [ Time Frame: up to 1 year ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • 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 ] [ Designated as safety issue: No ]
  • 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 ] [ Designated as safety issue: No ]
  • Assessment of total cholesterol [ Time Frame: up to 1 year ] [ Designated as safety issue: No ]
  • Assessment of free fatty acids [ Time Frame: up to 1 year ] [ Designated as safety issue: No ]
  • Assessment of high-density lipoprotein [ Time Frame: up to 1 year ] [ Designated as safety issue: No ]
  • Assessment low-density lipoprotein [ Time Frame: up to 1 year ] [ Designated as safety issue: No ]
  • Assessment of triglycerides [ Time Frame: up to 1 year ] [ Designated as safety issue: No ]
  • Assessment of LDL relative flotation [ Time Frame: up to 1 year ] [ Designated as safety issue: No ]
  • Assessment of total cholesterol/HDL ratio [ Time Frame: up to 1 year ] [ Designated as safety issue: No ]
  • Assessment of LDL/HDL ratio [ Time Frame: up to 1 year ] [ Designated as safety issue: No ]
  • Assessment of fasting blood glucose [ Time Frame: up to 1 year ] [ Designated as safety issue: No ]

Enrollment: 3592
Study Start Date: October 2004
Study Completion Date: October 2005
Primary Completion Date: October 2005 (Final data collection date for primary outcome measure)
Groups/Cohorts Assigned Interventions
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
were receiving an oral hypoglycemic agent (OHA) or insulin

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.

  Eligibility

Ages Eligible for Study:   18 Years to 75 Years
Genders Eligible for Study:   Both
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.

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.
  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.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01387165

Sponsors and Collaborators
GlaxoSmithKline
Investigators
Study Director: GSK Clinical Trials GlaxoSmithKline
  More Information

Additional Information:
No publications provided

Responsible Party: Cheri Hudson; Clinical Disclosure Advisor, GSK Clinical Disclosure
ClinicalTrials.gov Identifier: NCT01387165     History of Changes
Other Study ID Numbers: 105407
Study First Received: April 14, 2011
Last Updated: June 30, 2011
Health Authority: Brazil: Institutional Review Board

Keywords provided by GlaxoSmithKline:
Latin America
diabetes complications
patient compliance
Diabetes mellitus, type 2
health services accessibility

Additional relevant MeSH terms:
Diabetes Mellitus, Type 2
Diabetes Mellitus
Glucose Metabolism Disorders
Metabolic Diseases
Endocrine System Diseases

ClinicalTrials.gov processed this record on September 22, 2014