Usage of Dapagliflozin in the Management of Type-2 Diabetes Mellitus: A Real World Evidence Study in Indian Patients

Study Overview
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Brief Summary
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This study is a non-interventional, multicentre, prospective, observational study to be conducted at 50 sites in India. The study targets to enrol 2000 patients with 40 patients per site. The study will be initiated after obtaining written approval of Independent Ethics Committee (IEC) /Institutional Review Board (IRB) and written informed consent of the patient.

Detailed Description
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This study is a non-interventional, multicentre, prospective, observational study to be conducted at 50 sites in India. The study targets to enrol 2000 patients with 40 patients per site. The study would enrol T2DM patients who are/were inadequately controlled (HbA1c >7%) with existing anti-diabetic medications and who have been prescribed dapagliflozin 3 months prior to study initiation. No study medication will be prescribed or administered as a part of study procedure. Patients, who have been treated as per Investigators' routine clinical practice and prescribed dapagliflozin 3 months before will be screened for enrolment in study. Dosage of dapagliflozin and other medications should be as per the routine clinical practice and prescribing information. The study will be initiated after obtaining written approval of Independent Ethics Committee (IEC) /Institutional Review Board (IRB).

Official Title
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Usage of Dapagliflozin - a Sodium Glucose Co-transporter Inhibitor, in the managEment of Type-2 Diabetes Mellitus: A Real World Evidence Study in Indian Patients

Conditions
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Type 2 Diabetes

Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Male or female patients with 18 years and above. Patients who provide written informed consent. Patients with previously diagnosed Type-2 diabetes mellitus Patients with inadequately controlled diabetes (HbA1c >7%) with existing anti-diabetic medications, prior to initiation of dapagliflozin treatment. Patients who are taking dapagliflozin within last 3 months. Exclusion Criteria: Patients with Type-1 diabetes mellitus Patients with any medical condition which in the opinion of the investigator would interfere with safe completion of the study Pregnant or lactating women

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 99 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| To record the mean change in HbA1C from baseline | form basline visit to 6 months visit | 6 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| To record the change in weight | from Baseline to 6 month visit | 6 months | 
| To record the change in blood pressure | from baseline to 6 month visit | 6 months | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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T2DM, T2D,, Type 2 Diabetes,