Nephroprotective Effect of Nicorandil in Type 2 Diabetes Mellitus

Clinical Study Evaluating the Nephroprotective Effect of Nicorandil in Patients With Type 2 Diabetes Mellitus

Status

Recruiting

Phases

Phase 3

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT06430125

Enrollment

Registered

2024-05-28

Start date

2023-02-28

Completion date

2025-02-28

Last updated

2024-05-28

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

Conditions

Type2 Diabetes Mellitus

Brief summary

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

Interventions

DRUGNicorandil 10 MG Oral Tablet

Nicorandil 10 MG oral tablet twice daily

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

PREVENTION

Masking

NONE

Eligibility

Sex/Gender

ALL

Age

18 Years to 60 Years

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.

Design outcomes

Primary

Measure	Time frame	Description
prevention of progression of kidney disease as measured by KDIGO.	12 weeks	Patients wii undergo clinical assesment for progression of diabetic nephropathy as measured by KDIGO at baseline and after 12 weeks

Secondary

Measure	Time frame	Description
change in the serum concentrations of Kidney injury molecule 1(Kim-1).	12 weeks	Venous blood will be collected before treatment and after 12 week .
change in the serum concentrations of Interleukin 18 (IL-18).	12 weeks	Venous blood will be collected before treatment and after 12 week .
change in the serum concentrations of Nitric oxide (NO).	12 weeks	Venous blood will be collected before treatment and after 12 week .

Countries

Egypt

Contacts

Primary ContactMohammed A El-hazzab

mohamed150556@pharm.tanta.edu.eg201151998914

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026