In diabetes patients with kidney disease, which drug is better between pentoxifylline & dapagliflozin as an add on therapy to metformin, glimepiride & telmisartan in terms of kidney protection?

Evaluation of renoprotective efficacy & safety of pentoxifylline vs dapagliflozin as an add-on therapy to metformin, glimepiride and telmisartan in patients with diabetic nephropathy: A randomized controlled clinical study - nil

Status

Active, not recruiting

Phases

Phase 4

Study type

Interventional

Source

CTRI

Registry ID

CTRI/2023/10/059044

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: E112- Type 2 diabetes mellitus with kidney complications

Interventions

Intervention1: Metformin, Telmisartan, Glimepiride & Pentoxifylline : Intervention group will have 36 patients and receive the above treatment for 6 months. Control Intervention1: Metformin, Telmisart

Eligibility

Inclusion criteria

Inclusion criteria: 1. Subjects of more than 18 years of age of either gender suffering from type T2DM who are taking metformin, telmisartan plus glimepiride with persistent albuminuria >30mg/24 hour and estimated Glomerular filtration rate (eGFR) 45 to 90 mL/min/1.73m2. 2. Subjects with controlled blood pressure (=140/90) with medication. 3. Subjects with HbA1c <7% with medication.

Exclusion criteria

Exclusion criteria: 1. Subject refusing for written informed consent. 2. Subjects with type 1 diabetes mellitus. 3. Subjects with history of cerebral haemorrhage. 4. Subjects with history of any bleeding disorder. 5. Subjects with acute myocardial infarction or severe coronary disease. 6. Subjects with history of malignant disease, non-diabetic kidney disease. 7. Subjects with eGFR or more than 90 mL/min/1.73m2. 8. Subjects with symptoms suggestive of Urinary tract infection. 9. Subjects who have a history of hypersensitivity to any of the study drugs or any contraindication to any drug involved in this study. 10. Subjects with Baseline Serum Potassium concentration >5.5 mEq/L. 11. Subjects which are currently on dapagliflozin, pentoxifylline or other SGLT2 inhibitors. 12. Pregnant and breast-feeding females. 13. Subjects with history of drug allergy to theophylline and caffeine. 14. Subjects currently using ketorolac, warfarin, metoprolol, aspirin, clopidogrel, furosemide.

Design outcomes

Primary

Measure	Time frame
eGFR (Estimated Glomerular Filtration Rate), Serum Creatinine, AlbuminuriaTimepoint: Baseline, 1, 2, 4 & 6 month.	—

Secondary

Measure	Time frame
Albumin -Creatinine Ratio, Urine creatinine, Serum Albumin, Blood urea, Blood pressure (BP), Glycated hemoglobin (HbA1c), Plasma Glucose.Timepoint: Baseline, 1, 2, 4 & 6 month.	—

Countries

India

Contacts

Public ContactDr Monika Sharma

BPS govt. medical college for women, Khanpur Kalan, Sonipat

drrahulnanu@gmail.com9416837647

Outcome results

None listed

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