Subject: Participation in study “Assessment of drug utilization pattern of Dapagliflozin and Sitagliptin FDC in Indian type 2 diabetes mellitus patients (MIDAS-DM)”

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.

RSSDI 2022 recommends dual therapy if glucose control targets are not achieved. Addition of (SGLT2) inhibitor, or DPP-4 inhibitor or sulfonylurea or thiazolidinediones (TZDs) or sodium-glucose cotransporter 2 inhibitors, Alpha Glucosidase Inhibitor or oral Glucagon Like Peptide 1-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 lack of country wide data to obtain meaningful insights on the drug utilization pattern of dapagliflozin/sitagliptin FDC in patients with type 2 diabetes.

This retrospective, cross-sectional multicenter study is planned to evaluate the drug utilization pattern of dapagliflozin/sitagliptin FDC 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.