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How do dapagliflozin and vildagliptin differ in protecting the heart and ensuring safety when added to the regular treatment of patients who have both type 2 diabetes and high blood pressure?

Evaluation and comparison of cardioprotective efficacy and safety of dapagliflozin vs vildagliptin as an add-on therapy to standard treatment in patients with type 2 diabetes mellitus with hypertension - NIL

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
CTRI
Registry ID
CTRI/2025/10/096654
Enrollment
90
Registered
2025-10-30
Start date
Unknown
Completion date
Unknown
Last updated
2025-11-17

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Health Condition 1: I10- Essential (primary) hypertension Health Condition 2: E119- Type 2 diabetes mellitus without complications

Interventions

Intervention1: Tab Vildagliptin plus Standard treatment.: Intervention groups V will have 45 patients each will receive tab vildagliptin along with standard treatment for 6 months. Control Intervent

Sponsors

BPS GMC For Women
Lead Sponsor

Eligibility

Inclusion criteria

Inclusion criteria: 1. Age: 40- 79 years. 2. Diagnosis of type 2 diabetes mellitus Duration: more than or equal to 1 year HbA1c: 7.0 to 9.0(on current therapy) 3. Diagnosis of hypertension BP controlled On stable treatment for more than or equal to 4 weeks. Duration: more than or equal to 8 weeks before 4. Tablet metformin (500mg BD) and tablet glimepiride (2mg OD) enrolment. 5. Willingness to provide informed consent and comply with study protocol. 6. No changes in antihypertensive or antidiabetic medications in the last 4 weeks. 7. Body mass index (BMI) more than or equal to 22 kg/m2 .

Exclusion criteria

Exclusion criteria:

Design outcomes

Primary

MeasureTime frame
ASCVD 10 year risk score • Glycated Haemoglobin (HbA1c) • Fasting Plasma Glucose and post prandial glucose (FPG and PPG) • Bioelectrical Impedance Analysis (BIA): Body Composition Parameters • Blood pressure • Complete Blood Count (NLR, PLR, RPR): • Interleukin - 6 • Lipid ProfileTimepoint: ASCVD 10 year risk score • Glycated Haemoglobin (HbA1c) • Fasting Plasma Glucose and post prandial glucose (FPG and PPG) • Bioelectrical Impedance Analysis (BIA): Body Composition Parameters • Blood pressure • Complete Blood Count (NLR, PLR, RPR): • Interleukin - 6 • Lipid Profile—

Secondary

MeasureTime frame
SF-36 ScoreTimepoint: baseline and 6th month—

Countries

India

Contacts

Public ContactNiti
drrahulnanu@gmail.com9416837647

Outcome results

None listed

Source: CTRI (via WHO ICTRP) · Data processed: Feb 4, 2026