Effect of Nicorandil in Type 2 Diabetic Obese Patients

Tanta University

Status and phase: Enrolling; Phase 3; Phase 2

Conditions: Diabetes Mellitus, Type 2

Treatments: Drug: Nicorandil 10 MG

Study type: Interventional

Funder types: Other

Identifiers

NCT06423729

Nicorandil in DM

Details and patient eligibility

About

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.

Enrollment: 46 estimated patients

Sex: All

Ages: 18 to 60 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Diabetes duration ranged from 1 to 10 years.
• 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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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46 participants in 2 patient groups

Control Arm

No Intervention group

Description:

23 patients who will receive 2nd generation sulfonylureas only, for three months.

Nicorandil Arm

Experimental group

Description:

23 patients who will receive a combination of 2nd generation sulfonylureas and nicorandil 10 mg twice daily,for three months.

Treatment:

Drug: Nicorandil 10 MG