Dear Dr. {{$doctorName}}
Subject: Drug utilization pattern of Oral Antidiabetic agents in Management of Obese /
Overweight Patients with Type 2 diabetes Mellitus on the background of
availability of novel classes of Antidiabetic agents (AMPLIFY- II Study)
Type 2 diabetes is an obesity-related disease. The recent increase in the prevalence of type
2 diabetes worldwide has largely mirrored the rise in obesity, which may contribute to the
development of complications.
Obesity affects all organ systems, causing increased rates of cardiovascular and renal
disease, certain cancers, arthritis, and sleep apnea. More than 90% of patients with type 2
diabetes have a BMI ≥25.0 kg/m2. Abdominal obesity is a known risk factor for CVD
independent of BMI and is thought to affect disease risk through increased insulin
resistance.
Current ADA/EASD guidelines for the treatment of type 2 diabetes emphasise the
importance of lifestyle-promoted weight management for obese and overweight
individuals, and support an individualized choice of medication to favor medicines that
are ‘weight neutral’ or result in weight loss for individuals in whom weight loss is
considered a priority.
Diabetes and Obesity together increase risk of progression of diabetes and associated
cardiac and renal comorbidities, thus it becomes critical that emphasis is given to
recommendations given by ADA and RSSDI during management of such patients.
The present study is planned to evaluate drug utilization pattern of antidiabetic drugs for
associated conditions on the backdrop of available published clinical evidence on
improving the outcomes for comorbid conditions in obese or overweight patients with
T2DM.
We invite you to participate in this study. On acceptance, you will need to capture the
relevant data as mentioned in the standard Data Collection Form (DCF) provided, from
the patient’s medical records (case papers and investigational reports – hereafter referred as source documents).
We would recommend you to capture data fulfilling the criteria as outlined in the protocol
and whose relevant laboratory investigations are available for the preceding 3 months.
We wish to inform you that the DCF will capture all data in de-identified form and any
identifiable parameters which may potentially disclose the identity of the patient such as
name or address will strictly not be captured so as to ensure we maintain patient
confidentiality. We would encourage you to carefully fill all available information to the
fullest as recommended in the DCF.
In alignment with good clinical research practices, an independent Contract Research
Organization (CRO) will monitor this study and do the source data verification of the data
captured in the DCF with copies of the patients’ source medical records (case papers and
investigational reports) to ensure that the data entered in the DCFs are accurate and in
alignment with the patients’ medical records. The study is approved by independent
ethics committee.
If you agree to participate in the said study, we would request you to sign and return the
enclosed reply along with your visiting card for accuracy of records.
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