Dear Dr. {{$doctorName}}
Subject: Participation in study “Assessment of drug utilization pattern of Sitagliptin in
Indian type 2 Diabetes mellitus patients (RED)”
India has the second largest diabetic population in the world. The chronic nature of the
disease and high prevalence of co-existing chronic medical conditions or co morbidities makes diabetes management complex for the patient and for health care providers.
International Diabetes Federation (IDF 2021) has estimated that India currently has around 74 million people with type 2 diabetes mellitus (T2DM) and the numbers are
poised to increase to 125 million in the next 20 years.
The excess mortality risk in T2DM is due to high prevalence of major cardiovascular risk
factors such as hypertension (HTN), lipid abnormalities, smoking and obesity that are in
addition to factors specific to T2DM like hyperglycemia, diabetic dyslipidemia, and
oxidation-related and glycation-related vascular injury. If glucose control targets are not
achieved on metformin RSSDI 2022 recommends addition of DPP-4 inhibitor or sodium-
glucose cotransporter 2 inhibitors (SGLT2i), or sulfonylurea or thiazolidinediones (TZDs)
or Alpha Glucosidase Inhibitors or oral Glucagon like peptide - RA. A similar approach
has been advised by other guidelines as well.
Although diabetes prevalence is growing in India, there is a lack of evidence on whether
diabetes is adequately managed or not, in alignment with RSSDI 2022 guidelines. At
present, there is limited country wide data to obtain meaningful insights on the drug
utilization pattern of sitagliptin in patients with type 2 diabetes.
This retrospective, cross-sectional multicenter study is planned to evaluate the drug
utilization pattern of sitagliptin in patients with type 2 diabetes in India. 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 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.
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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