Subject:Assessment of drug utilization pattern of DPP4 inhibitors in Indian type 2 diabetes mellitus patients (RED-II)
Diabetes mellitus (DM) is a worldwide health problem with epidemic proportions and a huge economic burden. The global prevalence of DM in 2019 was estimated to be 9.3% (463 million people) with a projection to rise to 10.2% (578 million) by 2030 and 10.9% (700 million) by 2045. DM is a major cause of blindness, chronic kidney disease (CKD), stroke, lower extremity amputations and death from coronary heart disease and heart failure (HF). The ICMR-INDIAB study highlights the enormous burden of NCDs faced by India. It estimates the prevalence of diabetes and rediabetes in India to be 101 million and 136 million, respectively. DPP-4 inhibitors cause a clinically meaningful reduction in blood glucose, have a low risk of hypoglycemia and a neutral effect on body weight, while their safety profile is overall favorable. They are also easy to use, requiring no dose titration and can be taken at any time of day regardless of meal times. Furthermore, DPP-4 inhibitors exhibit non-glycemic favorable effects including reductions in systolic blood pressure, total cholesterol and triglycerides, as well as improvement in β-cell function. For the above reasons, until recently, they were a safe choice for the up titration of antidiabetic therapy after metformin. 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. Diabetes prevalence is at an alarming level 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 Dpp4 inhibitors in patients with type 2 diabetes.
This retrospective, cross-sectional multicenter study is planned to evaluate the drug utilization pattern of Dpp4 inhibitors 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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