Date: {{$ActivityAssignDate}}

Dear Dr. {{$doctorName}},


Subject: Assessment of drug utilization pattern of Dapagliflozin and Sitagliptin FDC in Indian type 2 diabetes mellitus patients with obesity (MIDAS-DMO Study)


Obesity is defined as excess and unhealthy body fat mass in a person and is a modifiable risk factor for various diseases. According to an ICMR-INDIAB-3 (Indian Council of Medical Research – INdia DIABetes) study, prevalence of generalized obesity (GO), abdominal obesity (AO) and combined obesity (CO) from different parts of India varies from 11.8–31.3%, 16.9–36.1% and 9.8–26.6%, respectively. Prevalence of obesity is 2–4 times more in diabetes mellitus as compared with the non-diabetic population. In a study by Daousi et al, 86% of type 2 diabetes mellitus (T2DM) were either overweight or obese and 52% were obese. Nowadays obesity and its complications such as diabetes mellitus (DM), hyperuricemia (HU), hypertension and cardiovascular disease (CVD) have emerged as a serious concern for public health and put a substantial economic burden on society. The lifetime diabetes risk in men older than 18 years increases from 7% to 70% and in females increases from 12% to 74% when BMI increases from less than 18.5 kg/m to more than 35 kg/m.


WHO classification of BMI for the Asian population.


Underweight <18.5 kg/m2
Normal Weight 18.5–22.9 kg/m2
Overweight >23 kg/m2
Obese >25kg/m2


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, Metformin as the first line drug and GLP-1 analogues, DPP-4 inhibitors and SGLT2 inhibitors as add-ons in obese T2DM patients in addition to lifestyle changes.


Although diabetes in obesity 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 obese patients with type 2 diabetes.


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

Yours truly,

Sun Pharma Laboratories Limited

Sun House, 201/B1, Western Express Highway,

Goregaon (East), Mumbai,

Maharashtra (India) – 400 063