Nephroprotective Effect of Nicorandil in Type 2 Diabetes Mellitus

NCT06430125 | Recruiting Phase 3

• 1 other identifier: Nicorandil Nephroprotective
• Study Type: interventional
• Target: 46
• Locations: 1 country
• Sites: 1

Brief Summary

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

Conditions

Type2 Diabetes Mellitus

Outcome Measures

Primary Outcomes (1)

• prevention of progression of kidney disease as measured by KDIGO.

  Patients wii undergo clinical assesment for progression of diabetic nephropathy as measured by KDIGO at baseline and after 12 weeks

  12 weeks

Secondary Outcomes (3)

• change in the serum concentrations of Kidney injury molecule 1(Kim-1).

  12 weeks

• change in the serum concentrations of Interleukin 18 (IL-18).

  12 weeks

• change in the serum concentrations of Nitric oxide (NO).

  12 weeks

Study Arms (2)

Control group

NO INTERVENTION

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

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 .

Drug: Nicorandil 10 MG Oral Tablet

Interventions

Nicorandil 10 MG Oral Tablet DRUG

Nicorandil 10 MG oral tablet twice daily

Nicorandil group

Eligibility Criteria

• Age: 18 Years - 60 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• 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 .

You may not qualify if:

• 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.

Sponsors & Collaborators

• Tanta University: lead

Study Sites (1)

Tanta University

Tanta, EL Gharbia, Egypt

RECRUITING

MeSH Terms

Interventions

Nicorandil; Tablets

Intervention Hierarchy (Ancestors)

Nitrates; Organic Chemicals; Niacinamide; Nicotinic Acids; Acids, Heterocyclic; Heterocyclic Compounds; Pyridines; Heterocyclic Compounds, 1-Ring; Dosage Forms; Pharmaceutical Preparations

Central Study Contacts

Mohammed A El-hazzab

CONTACT

201151998914; mohamed150556@pharm.tanta.edu.eg

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: May 21, 2024
• First Posted: May 28, 2024
• Study Start: February 28, 2023
• Primary Completion: February 1, 2025
• Study Completion: February 1, 2025
• Last Updated: May 28, 2024

Record last verified: 2024-05

Locations

EG (1)