Nephroprotective Effect of Nicorandil in Type 2 Diabetes Mellitus

Tanta University

Status and phase: Enrolling; Phase 3

Conditions: Type2 Diabetes Mellitus

Treatments: Drug: Nicorandil 10 MG Oral Tablet

Study type: Interventional

Funder types: Other

Identifiers

NCT06430125

Nicorandil Nephroprotective

Details and patient eligibility

About

This study aims to evaluate the possible nephroprotective effect of nicorandil in patients with type 2 diabetes mellitus .

Enrollment: 46 estimated patients

Sex: All

Ages: 18 to 60 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Patients newly diagnosed with T2DM with diet control and good glycemic index ( Hb A1C< 7 )
• Age range between 18 and 60 years old.
• Both sexes.
• Stage 1and Stage 2 CKD according to KDIGO .
• Controlled HTN .

Exclusion criteria

• Pregnant and lactating females.
• Patients with hypersensitivity to nicorandil.
• Other Causes of CKD or Nephropathy eg : Uncontrolled HTN , Renal Malignancy , collagen disease as Amyloidosis and some autoimmune disease as ( SLE and Rh.fever ) .
• Uncontrolled HTN and its antihypertensive medications ( ACEI , ARB ) and other antihypertensive medications .
• Patients receiving nephrotoxic drugs as aminoglycosides, non-steroidal anti inflammatory drugs and contrast media.

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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46 participants in 2 patient groups

Control group

No Intervention group

Description:

this group will include 23 patients who will receive metformin 2gm/day. The initial dose of metformin will be 1 g/day taken orally with the meal. After 7 days (week 1), the dose will be up titrated to daily dose of 2,000 mg/day. Treatment duration will be 12 weeks .

Nicorandil group

Active Comparator group

Description:

this group will include 23 patients who will receive a combination of metformin 2g/day and nicorandil 10 mg twice daily. The initial dose of metformin will be 1 g/day taken orally with the meal. After 7 days (week 1), the dose will be uptitrated to daily dose of 2,000 mg/day. Treatment duration will be 12 weeks .

Treatment:

Drug: Nicorandil 10 MG Oral Tablet