verapamil use in treatment of type 2 diabetes mellitus with cardiac comorbidities

Assessment of the efficacy and safety of Verapamil as an add-on therapy in the management of Type 2 Diabetes Mellitus patients with cardiac comorbidities- A Randomized, Open Label, Parallel Arm Study - NIL

Status

Active, not recruiting

Phases

Phase 4

Study type

Interventional

Source

CTRI

Registry ID

CTRI/2024/04/065649

Enrollment

110

Registered

2024-04-15

Start date

Unknown

Completion date

Unknown

Last updated

2024-04-29

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

Conditions

Health Condition 1: E11- Type 2 diabetes mellitus

Interventions

Intervention1: verapamil: 40 mg twice a day for 3 months Control Intervention1: standard therapy: T. metformin 500 mg twice a day 3 months

Eligibility

Inclusion criteria

Inclusion criteria: type 2 diabetes mellitus with HBA1C ranging 6.5 to 8 mg/dl people with cardiac comorbidities such as Coronary artery disease, hypertension , supra ventricular arrythmia, hyperlipidemia , stable unstable variant angina , atrial fibrillation, coronary atherosclerosis ,supraventricular tachycardia

Exclusion criteria

Exclusion criteria: Patients who are on insulin therapy Pregnant and lactating women Uncompensated heart failure, fluid overload, severe left ventricular dysfunction with ejection fraction less than 30 ,cardiogenic shock ,Severe hypotension (systolic pressure less than 90 mm Hg)PR interval prolongation on electrocardiogram (ECG) or bradyarrhythmia ( sick sinus syndrome, 1st degree , 2nd degree and 3rd degree AV block) sinus bradycardia , pulmonary edema , hypertrophic cardiomyopathy, atrial fibrillation or flutter associated with accessory bypass tract ( wolf –Parkinson white syndrome ) Duchenne muscular atrophy and myasthenia gravis. Hepatic impairment (child Pugh class A, B, C) and renal impairment (estimated glomerular filtration rate less than 45 mmhg) Pre-existing medications that the patient is taking that interact adversely with verapamil or contraindicated to be taken together Alcoholic and smokers

Design outcomes

Primary

Measure	Time frame
To evaluate the anti-diabetic effect and safety of Verapamil on Type II Diabetes Mellitus with cardiac comorbidities. To study the effect of Verapamil on laboratory parameters namely HbA1c (glycated hemoglobin), FBS (fasting blood sugar), PPBS (post prandial blood sugar), c-Peptide, fasting insulin and HOMA-B (homeostasis model assessment of beta cell function) levels. Timepoint: Baseline and 12 weeks	—

Measure

Time frame

To evaluate the anti-diabetic effect and safety of Verapamil on Type II Diabetes Mellitus with cardiac comorbidities. To study the effect of Verapamil on laboratory parameters namely HbA1c (glycated hemoglobin), FBS (fasting blood sugar), PPBS (post prandial blood sugar), c-Peptide, fasting insulin and HOMA-B (homeostasis model assessment of beta cell function) levels. Timepoint: Baseline and 12 weeks

—

Secondary

Measure	Time frame
Quality of life (QOL) assessment by D-39 questionnaire. Medication Adherence is assessed by Morisky 8- item Medication Adherence Questionnaire. Timepoint: 6 months	—

Countries

India

Contacts

Public Contactlokesh

SRM Institute of Science and Technology

jagadeem1@srmist.edu.in7449277556

Outcome results

None listed

Source: CTRI (via WHO ICTRP) · Data processed: Feb 4, 2026