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Effectiveness and Safety of diabetic drugs in diabetic participants

Comparison of Effectiveness and Safety of Dapagliflozin and Empagliflozin in Type 2 Diabetes Mellitus - NIL

Status
Active, not recruiting
Phases
Phase 4
Study type
Interventional
Source
CTRI
Registry ID
CTRI/2024/07/071196
Enrollment
104
Registered
2024-07-24
Start date
Unknown
Completion date
Unknown
Last updated
2026-06-01

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

Conditions

Health Condition 1: E11- Type 2 diabetes mellitus

Interventions

Intervention1: Empagliflozin 25mg OD for 20 weeks: Empagliflozin 25mg OD for 20 weeks Control Intervention1: Dapagliflozin 5mg OD: Dapagliflozin 5mg OD

Sponsors

Dr Manu Arya
Lead Sponsor

Eligibility

Inclusion criteria

Inclusion criteria: All Patients with Type2 diabetes mellitus as per ADA guidelines Patients of either gender with age more than 18 years. Patients giving written informed consent.

Exclusion criteria

Exclusion criteria: Pregnant & lactating women. Patients not complying with the study protocol. Patients with underlying comorbid conditions like recurrent UTI, chronic renal diseases. Patients with co-morbid conditions like malignancy, psychiatric disorders, substance abuse Patients with concomitant medications likely to interfere with glycemic control e.g.: Steroids, Beta-blockers, Thiazide Diuretics

Design outcomes

Primary

MeasureTime frame
Fasting Plasma Glucose(FPG), glycosylated haemoglobin(HbA1c), NT-pro BNP , Kidney function Test(KFT) Timepoint: Fasting Plasma Glucose(FPG), glycosylated haemoglobin(HbA1c), NT-pro BNP , Kidney function Test(KFT) follow up after 4 weeks and 8 weeks

Secondary

MeasureTime frame
Adverse drug monitoring using a pre-validated ADR checklist along with spontaneous reporting Timepoint: Changes in NT-proBNP, KFT & FPG from baseline to End of the study follow up after 4 weeks & 8 weeks

Countries

India

Contacts

Public ContactDr Manu Arya

Teerthanker Mahaveer University Medical College and Research Centre

drpsmatreja@yahoo.co.in9855001847

Outcome results

None listed

Source: CTRI (via WHO ICTRP) · Data processed: Jun 11, 2026