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A comparison between Vildagliptin and Dapagliflozin in Diabetes Mellitus patients in addition to Metformin

An Institution based open label randomized controlled comparative clinical study between Vildagliptin and Dapagliflozin in Type 2 Diabetes Mellitus patients who are not controlled by Metformin monotherapy

Status
Active, not recruiting
Phases
Phase 4
Study type
Interventional
Source
CTRI
Registry ID
CTRI/2023/02/049942
Enrollment
110
Registered
2023-02-21
Start date
Unknown
Completion date
Unknown
Last updated
2023-03-06

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

Conditions

Health Condition 1: E119- Type 2 diabetes mellitus without complications

Interventions

Intervention1: Vildagliptin plus Metformin: One arm will receive tablet Vildagliptin 50mg twice daily before meals plus tablet Metformin 500mg two tablets in the morning after breakfast, one tablet in

Sponsors

Dr Bratati Sanyal
Lead Sponsor

Eligibility

Inclusion criteria

Inclusion criteria: Patients of either sex aged from 18 to 65, who are on oral Metformin therapy of 2000mg/day for type 2 diabetes mellitus for at least six months and with HbA1c values between 6.5 to 9, attending the General Medicine OPD of college of Medicine & Sagore Dutta Hospital, Kamarhati, Kolkata.

Exclusion criteria

Exclusion criteria: Pregnant and lactating women and patients planning for pregnancy in next few months. Patients suffering from any acute illness at the time of screening. Patients with known history of any hypersensitivity reactions from any of the study drugs. Patients who have already enrolled for any other ongoing clinical trial.

Design outcomes

Primary

MeasureTime frame
To compare the efficacies of Vildagliptin and Dapagliflozin in terms of reduction of HbA1c from baseline. To compare the safety of Vildagliptin and Dapagliflozin Timepoint: 0, 12 weeks, 24 weeks

Secondary

MeasureTime frame
To compare the reduction in FBS, PPBS, lipid profile, serum urea, creatinine, ACR in case of Vildagliptin and DapagliflozinTimepoint: 0, 12 weeks, 24 weeks

Countries

India

Contacts

Public ContactDr Bratati Sanyal

College of Medicine And Sagore Dutta Hospital

drprithwijit@gmail.com9830500513

Outcome results

None listed

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