Diabetes Mellitus, Type 2DEALNCT01387165
Epidemiologic Survey to Describe the Current Medical Practice of General Practitioners Treating Subjects With Type 2 Diabetes Mellitus in Latina
An observational study of Diabetes Mellitus, Type 2, run by GlaxoSmithKline.
Trial 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 more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Diabetes Mellitus, Type 2
- What is being tested?
- Treatment
- Type of treatment
- Pill or oral medicine
- How many people
- 3,592 participants
- Where
- No sites listed yet
- Study dates
- Oct 2004to Oct 2005
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
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.
Who may be able to join
- 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.
Who cannot join
None listed.
About this study
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
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.
- Conditions
- Diabetes Mellitus, Type 2
- Being tested
- Treatment
- Keywords
- Latin America, diabetes complications, patient compliance, Diabetes mellitus, type 2, health services accessibility
- Medical subject headings
- Diabetes Mellitus, Type 2, Diabetes Complications, Patient Compliance
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
TreatmentDrug
were receiving an oral hypoglycemic agent (OHA) or insulin
| Study group | Role | What they receive |
|---|---|---|
| Patients | males and females between 18 and 75 years of age who been diagnosed with T2DM as defined by the American Diabetes Association Receives: Drug: Treatment |
What is being measured
The primary outcome is the main question the study is designed to answer.
The achievement of the planned completed number of questionnaires.
Measured: up to 1 year
Secondary outcomes (11)
Changes in glycemic parameters in accordance with the historical information provided by the GPs and her/his judgement of control based on that information.
Measured: 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%)
Measured: up to 1 year
Assessment of total cholesterol
Measured: up to 1 year
Assessment of free fatty acids
Measured: up to 1 year
Assessment of high-density lipoprotein
Measured: up to 1 year
Assessment low-density lipoprotein
Measured: up to 1 year
Assessment of triglycerides
Measured: up to 1 year
Assessment of LDL relative flotation
Measured: up to 1 year
Assessment of total cholesterol/HDL ratio
Measured: up to 1 year
Assessment of LDL/HDL ratio
Measured: up to 1 year
Assessment of fasting blood glucose
Measured: up to 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Jul 2011 (estimated)
- Study startOct 2004
- Primary completionOct 2005
- Study completionOct 2005
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Diabetes Mellitus, Type 2Studies of the same condition, open and under way.
- More trials run by GlaxoSmithKlineThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Other
- Time perspective
- Cross-sectional
- Enrolment
- 3,592 participants (actual)
Sponsor and investigators
- Lead sponsor
- GlaxoSmithKline
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- GSK Clinical Trials, Study director, GlaxoSmithKline
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01387165
- Sponsor's protocol ID
- 105407
- Acronym
- DEAL
- Status last verified
- May 2017
- First submitted
- 14 Apr 2011
- Last updated
- 8 Jun 2017
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 8 Jun 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT01387165
- Acronym / sponsor ID
- DEAL / 105407
- Conditions
- Diabetes Mellitus, Type 2
- Keywords
- Latin America, diabetes complications, patient compliance, Diabetes mellitus, type 2, health services accessibility
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 3,592 participants (actual)
- Lead sponsor
- GlaxoSmithKlineIndustry (pharma, biotech, devices)
- Study start
- Oct 2004
- Primary completion
- Oct 2005 (actual)
- Study completion
- Oct 2005 (actual)
- First posted
- 4 Jul 2011 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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
- Observational model
- Other
- Time perspective
- Cross-sectional
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Patients | – | Drug: Treatmentmales and females between 18 and 75 years of age who been diagnosed with T2DM as defined by the American Diabetes Association |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- 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.
Key inclusion criteria (4 listed)
- 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.
Key exclusion criteria (0 listed)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Treatmentwere receiving an oral hypoglycemic agent (OHA) or insulin | Drug | Patients |
Primary outcome
The achievement of the planned completed number of questionnaires.
Time frame: up to 1 year
11 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.
Time frame: 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%)
Time frame: up to 1 year
Assessment of total cholesterol
Time frame: up to 1 year
Assessment of free fatty acids
Time frame: up to 1 year
Assessment of high-density lipoprotein
Time frame: up to 1 year
Assessment low-density lipoprotein
Time frame: up to 1 year
Assessment of triglycerides
Time frame: up to 1 year
Assessment of LDL relative flotation
Time frame: up to 1 year
Assessment of total cholesterol/HDL ratio
Time frame: up to 1 year
Assessment of LDL/HDL ratio
Time frame: up to 1 year
Assessment of fasting blood glucose
Time frame: up to 1 year
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 Jun 2017.
- Control of type 2 diabetes mellitus among general practitioners in private practice in nine countries of Latin AmericaLink provided by the sponsor.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
GSK Clinical Trials study director
GlaxoSmithKline
Questions about this trial
What is this clinical trial studying?
An observational study of Diabetes Mellitus, Type 2, run by GlaxoSmithKline.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 0 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 8 Jun 2017. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
The achievement of the planned completed number of questionnaires. (time frame: up to 1 year). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 8 Jun 2017; AzTrials last refreshed its copy on 8 Nov 2026.