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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.
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).
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| Measure | Description | Time Frame |
|---|---|---|
| To record the mean change in HbA1C from baseline | form basline visit to 6 months visit | 6 months |
| 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 |
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Inclusion Criteria:
Exclusion Criteria:
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Type 2 diabetes
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| Name | Affiliation | Role |
|---|---|---|
| Dr Vijay Viswanathan, M.D., Ph.D., FRCP | MV Hospital Chennai India | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Research Site | Hyderabad | Andhra Pradesh | India | |||
| Research Site |
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| Label | URL |
|---|---|
| D1690R00029 CSR synopsis | View source |
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no samples retained
| 6 months |
| Nellor |
| Andhra Pradesh |
| India |
| Research Site | Vijayawada | Andhra Pradesh | India |
| Research Site | Raipur | Chhattisgarh | India |
| Research Site | Ahmedabad | Gujarat | India |
| Research Site | Rajkot | Gujarat | India |
| Research Site | Surat | Gujarat | India |
| Research Site | Bangalore | Karnataka | India |
| Research Site | Aurangabad | Maharashtra | India |
| Research Site | Mumbai | Maharashtra | India |
| Research Site | Nagpur | Maharashtra | India |
| Research Site | Pune | Maharashtra | India |
| Research Site | New Delhi | National Capital Territory of Delhi | India |
| Research Site | Amritsar | Punjab | India |
| Research Site | Bhathinda | Punjab | India |
| Research Site | Chandigarh | Punjab | India |
| Research Site | Ludhiana | Punjab | India |
| Research Site | Patiāla | Punjab | India |
| Research Site | Jaipur | Rajasthan | India |
| Research Site | Chennai | Tamil Nadu | India |
| Research Site | Coimbatore | Tamil Nadu | India |
| Research Site | Madurai | Tamil Nadu | India |
| Research Site | Pudhucherry | Tamil Nadu | India |
| Research Site | Salem | Tamil Nadu | India |
| Research Site | Hyderabad | Telangana | India |
| Research Site | Kanpur | Uttar Pradesh | India |
| Research Site | Lucknow | Uttar Pradesh | India |
| Research Site | Jalpāiguri | West Bengal | India |
| Research Site | Kolkata | West Bengal | India |
| ID | Term |
|---|---|
| D003924 | Diabetes Mellitus, Type 2 |
| ID | Term |
|---|---|
| D003920 | Diabetes Mellitus |
| D044882 | Glucose Metabolism Disorders |
| D008659 | Metabolic Diseases |
| D009750 | Nutritional and Metabolic Diseases |
| D004700 | Endocrine System Diseases |
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