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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.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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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.

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 groups in NCT01387165
Study groupRoleWhat they receive
Patientsmales 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.

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

    Measured: up to 1 year

Secondary outcomes (11)
  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.

    Measured: 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%)

    Measured: up to 1 year

  3. Assessment of total cholesterol

    Measured: up to 1 year

  4. Assessment of free fatty acids

    Measured: up to 1 year

  5. Assessment of high-density lipoprotein

    Measured: up to 1 year

  6. Assessment low-density lipoprotein

    Measured: up to 1 year

  7. Assessment of triglycerides

    Measured: up to 1 year

  8. Assessment of LDL relative flotation

    Measured: up to 1 year

  9. Assessment of total cholesterol/HDL ratio

    Measured: up to 1 year

  10. Assessment of LDL/HDL ratio

    Measured: up to 1 year

  11. 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.

  1. First posted4 Jul 2011 (estimated)
  2. Study startOct 2004
  3. Primary completionOct 2005
  4. Study completionOct 2005

Resources

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)
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

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.

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