Effect of Nicorandil in Type 2 Diabetic Obese Patients

Clinical Study Evaluating the Effect of Nicorandil in Type 2 Diabetic Obese Patients Treated With Sulfonylurea

Status

Completed

Phases

Phase 2

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT06423729

Enrollment

Registered

2024-05-21

Start date

2023-11-01

Completion date

2024-11-30

Last updated

2026-08-12

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

Conditions

Diabetes Mellitus, Type 2

Keywords

Type 2 DM, Nicorandil, Obesity

Brief summary

1. Evaluating the effect of nicorandil on glycemic control of diabetic obese patients treated with sulfonylureas. 2. Investigating the effect of nicorandil on body weight of diabetic obese patients treated with sulfonylureas.

Interventions

DRUGNicorandil 10 MG

Patients will receive oral Nicorandil 10 MG twice daily in addition to 2nd generation sulfonylureas , for 3 months.

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Masking

NONE

Eligibility

Sex/Gender

ALL

Age

18 Years to 60 Years

Healthy volunteers

Inclusion criteria

* Patients newly diagnosed with diabetes . * Body mass index (BMI) \>30 Kg/m2. * The selected patients are treated with sulfonylureas alone. * The age of selected patient ranged from 18 and 60 years.

Exclusion criteria

* Pregnant and lactating females. * Patients with hypersensitivity to nicorandil. * Uncontrolled hypertension and its antihypertensive medications * Severe renal or hepatic disease.

Design outcomes

Primary

Measure	Time frame	Description
Change in HbA1c level	The participants will be assessed before initiation of the study (baseline), and at the end of the study after 3 months.	Change in HbA1c (From baseline to 12 weeks)
Change in body weight.	The participants will be assessed before initiation of the study (baseline), and at the end of the study after 3 months.	Change in body weight (From baseline to 12 weeks).
Change in Body mass index (BMI)	The participants will be assessed before initiation of the study (baseline), and at the end of the study after 3 months.	Change in Body mass index (BMI) (From baseline to 12 weeks).
Change in Visceral adiposity index (VAI).	The participants will be assessed before initiation of the study (baseline), and at the end of the study after 3 months.	Change in Visceral adiposity index (VAI) (From baseline to 12 weeks).

Secondary

Measure	Time frame	Description
Change in Adiponenctin, Interleukin-6 (IL-6) and Nitric oxide (NO) serum levels.	The participants will be assessed before initiation of the study (baseline), and at the end of the study after 3 months.	Assessment of Adiponenctin, Interleukin-6 (IL-6) and Nitric oxide levels by ELISA Kits according to manufacturer's instructions.

Countries

Egypt

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Aug 13, 2026