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?

Phase 4

• Conditions: Health Condition 1: E112- Type 2 diabetes mellitus with kidney complications

• Registration Number: CTRI/2023/10/059044
• Lead Sponsor: Bhagat Phool Singh Govt. Medical College For Women

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Last Update Posted: 13 November 2023

Recruitment & Eligibility

• Status: ot Yet Recruiting
• Sex: Not specified
• Target Recruitment: 0

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

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 <45mL/min/1.73m2

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.

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

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

Secondary Outcome Measures

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