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A study to compare effectiveness and safety of oral antidiabetic drugs Dapagliflozin plus metformin combination with Sitagliptin plus Metformin combination in Type-2 Diabetes Mellitus patients.

A Prospective Observational Study On Effectiveness And Safety Of Dapagliflozin Versus Sitagliptin As An Add-On To Metformin In Type 2 Diabetes Mellitus At A Tertiary Care Hospital - MDMS Trial

Status
Active, not recruiting
Phases
Unknown
Study type
Observational
Source
CTRI
Registry ID
CTRI/2025/06/089588
Enrollment
80
Registered
2025-06-25
Start date
Unknown
Completion date
Unknown
Last updated
2025-07-21

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: Nil: Nil Intervention2: Nil: Nil Intervention3: Nil: Nil

Sponsors

Dr Pragyan Paramita Bairisal
Lead Sponsor

Eligibility

Inclusion criteria

Inclusion criteria: Treatment naive newly diagnosed Type 2 Diabetes Mellitus patients as per ADA criteria. HbA1c more than or equal to 6.5 Patients receiving either combination of metformin 1000mg per day plus sitagliptin 100mg per day or combination of metformin 1000mg per day plus dapagliflozin 10mg per day. Subjects who have given consent

Exclusion criteria

Exclusion criteria: History of drug allergy to metformin/dapagliflozin/sitagliptin. Other types of clinical diabetes. Pregnancy/Breastfeeding or those contemplating pregnancy in women of reproductive age group. Patients with acute metabolic decompensation such as Hyperglycemic hyperosmolar state /Diabetic ketoacidosis Patients with Chronic kidney disease, Chronic liver disease, coronary artery disease or Stroke within preceding 6 months.

Design outcomes

Primary

MeasureTime frame
To evaluate and compare glycemic control of group taking metformin and dapagliflozin combination with group taking metformin and sitagliptin combination as determined by reduction in HbA1c . Timepoint: Baseline HbA1c at zero week and 12 week will be recorded and compared

Secondary

MeasureTime frame
1- To assess the lipid profile and weight changes. Timepoint: Baseline(0 week) and 12 weeks;To assess the adverse effects of the drugsTimepoint: Baseline (0 week) till 12 weeks

Countries

India

Contacts

Public ContactDr PRAGYAN PARAMITA BAIRISAL

Institute of Medical Science And SUM Hospital

karmajeetrath@soa.ac.in9438911361

Outcome results

None listed

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