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This randomized controlled trial studied whether empagliflozin lowers blood pressure better than non-SGLT2 oral hypoglycemic treatment in adults with type 2 diabetes mellitus and hypertension. A total of 300 participants were assigned to 1 of 2 treatment groups and followed for 12 weeks. One group received empagliflozin and the other received non-SGLT2 oral therapy. Blood pressure was measured at baseline and again after 12 weeks to compare the effect of treatment on systolic and diastolic blood pressure.
This single-center randomized controlled trial was conducted in the Department of Internal Medicine, Shahida Islam Teaching Hospital, Lodhran, Pakistan. Adults aged 20 to 70 years with type 2 diabetes mellitus and hypertension of more than 3 months duration were enrolled. Patients with heart failure, chronic renal failure, pregnancy, or a history of hypertension preceding type 2 diabetes mellitus by more than 6 months were excluded. A total of 300 participants were randomized into 2 parallel groups. Group A received empagliflozin 10 mg for the first 4 weeks, increased to 25 mg up to week 12. Group B received non-SGLT2 oral hypoglycemic therapy with metformin 500 mg twice daily. Blood pressure was recorded at baseline and after 12 weeks of treatment. The primary objective was to compare changes in systolic and diastolic blood pressure between the 2 groups after 12 weeks of treatment.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Empagliflozin | Experimental | Participants received empagliflozin 10 mg once daily for the first 4 weeks, increased to 25 mg once daily until week 12. |
|
| Metformin | Active Comparator | Participants received metformin 500 mg twice daily for 12 weeks. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Empagliflozin | Drug | Empagliflozin 10 mg once daily for the first 4 weeks, increased to 25 mg once daily until week 12. |
|
| Measure | Description | Time Frame |
|---|---|---|
| Change in Systolic Blood Pressure | Change in systolic blood pressure from baseline to 12 weeks after assigned treatment. | Baseline to 12 weeks |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Zarmina Younes | Department of Internal Medicine, Shahida Islam Teaching Hospital, Lodhran, Pakistan | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Shahida Islam Medical College, Lodhran | Lodhran | Punjab Province | Pakistan |
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| ID | Term |
|---|---|
| D003924 | Diabetes Mellitus, Type 2 |
| D006973 | Hypertension |
| ID | Term |
|---|---|
| D003920 | Diabetes Mellitus |
| D044882 | Glucose Metabolism Disorders |
| D008659 | Metabolic Diseases |
| D009750 | Nutritional and Metabolic Diseases |
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| ID | Term |
|---|---|
| C570240 | empagliflozin |
| D008687 | Metformin |
| ID | Term |
|---|---|
| D001645 | Biguanides |
| D006146 | Guanidines |
| D000578 | Amidines |
| D009930 | Organic Chemicals |
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Blood pressure outcomes were assessed by a ward doctor who was not aware of study group allocation.
| Metformin | Drug | Metformin 500 mg twice daily for 12 weeks. |
|
| D004700 | Endocrine System Diseases |
| D014652 | Vascular Diseases |
| D002318 | Cardiovascular Diseases |