A study on the effect of Dapagliflozin and Metformin combination on Insulin resistance and cardiovascular disease risk factors in subjects with type II diabetes mellitus

Effect of Dapagliflozin and Metformin Combination on Insulin Resistance and Cardiovascular Disease Risk Factors in Drug Naïve Type II Diabetes Mellitus Patients in a Tertiary Care Hospital: An Open Label Randomized Controlled Trial - NIL

Status

Active, not recruiting

Phases

Phase 3Phase 4

Study type

Interventional

Source

CTRI

Registry ID

CTRI/2023/10/059034

Enrollment

Registered

2023-10-23

Start date

Unknown

Completion date

Unknown

Last updated

2023-11-13

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

Conditions

Health Condition 1: E118- Type 2 diabetes mellitus with unspecified complications

Interventions

Intervention1: Tab. Metformin-Dapagliflozin FDC (fixed dose combinaton): Tab. Metformin-Dapagliflozin FDC (Dapagliflozin 5mg and Tab. Metformin 500mg) once daily in the morning after food for 12 week

Eligibility

Inclusion criteria

Inclusion criteria: 1) Male/female aged 18-60 years 2) Newly diagnosed with type 2 diabetes mellitus patients (FBS >126mg/dl and PPBS >200mg/dl) 3) HbA1c level 7% to 8% 4) Newly diagnosed type II diabetes with or without hypertension and dyslipidemia

Exclusion criteria

Exclusion criteria: 1) Diabetes with renal failure 2) Diabetes with liver failure 3) Pregnancy and lactation, psychiatric patients 4) Age above 60 years 5) Patients who are not willing to give informed consent

Design outcomes

Primary

Measure	Time frame
1) TyG index, TG to HDL C ratio from baseline to 12 weeks 2) Changes in FBS, PPBS & HbA1c, serum uric acid, systolic BP, body mass index, abdominal circumference, waist circumference, neck circumference, waist to hip ratio from baseline to 12 weeks Timepoint: baseline to 12 weeks	—

Secondary

Measure	Time frame
Assessing the tolerability & safety of monotherapy and combination therapy based on patient reported outcomesTimepoint: baseline to 12 weeks	—

Countries

India

Contacts

Public ContactDr Jamuna Rani

SRM Medical College Hospital and Research Centre

hod.medpharm.ktr@srmist.edu.in9840279010

Outcome results

None listed

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