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

Sponsor

GlaxoSmithKline (Industry)

Overall Status

Completed

CT.gov ID

NCT01387165

Collaborator

(none)

3,592

Enrollment

Duration (Months)

Study Details

Study Description

Brief Summary

Condition or Disease	Intervention/Treatment	Phase
Diabetes Mellitus, Type 2	Drug: Treatment

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.

Study Design

Study Type:

Observational

Actual Enrollment :

3592 participants

Observational Model:

Other

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

Study Start Date :

Oct 1, 2004

Actual Primary Completion Date :

Oct 1, 2005

Actual Study Completion Date :

Oct 1, 2005

Arms and Interventions

Arm	Intervention/Treatment
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

Arm

Intervention/Treatment

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

Outcome Measures

Primary Outcome Measures

The achievement of the planned completed number of questionnaires. [up to 1 year]

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. [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%) [up to 1 year]
Assessment of total cholesterol [up to 1 year]
Assessment of free fatty acids [up to 1 year]
Assessment of high-density lipoprotein [up to 1 year]
Assessment low-density lipoprotein [up to 1 year]
Assessment of triglycerides [up to 1 year]
Assessment of LDL relative flotation [up to 1 year]
Assessment of total cholesterol/HDL ratio [up to 1 year]
Assessment of LDL/HDL ratio [up to 1 year]
Assessment of fasting blood glucose [up to 1 year]

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years to 75 Years

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

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.