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Efficacy of Ranolazine in reduction of blood sugar in type 2 diabetic patients with ischemic heart disease

Phase 3
Conditions
Condition 1: Diabetes mellitus. Condition 2: Stable angina.
Type 2 diabetes mellitus with hyperosmolarity
Other forms of angina pectoris
Registration Number
IRCT20161026030511N3
Lead Sponsor
Samin Daroo Company
Brief Summary

Not available

Detailed Description

Not available

Recruitment & Eligibility

Status
Complete
Sex
All
Target Recruitment
60
Inclusion Criteria

HbA1c more than 6.5%, Age more than 50 year, both genders with diabetes mellitus and coronary artery disease (CAD)
Experiencing chronic stable angina for at least 3 months triggered by physical effort and relieved by rest and/or sublingual nitroglycerin
CAD documented by one or more of the following: Angiography evidence of more than 50% stenosis of one or more coronary arteries, History of MI, cardiac imaging or exercise test diagnostic for CAD
Treatment with up to 2 anti-anginal therapies at a stable dose for at least 2 weeks before starting the trial
T2DM patients who use Metformin and Gliclazide

Exclusion Criteria

New York Heart Association class III and IV
Acute coronary syndrome in the prior 2 months or planned for coronary revascularization
Stroke or transient ischemic attack within 6 months prior
QTc more than 500 ms
Systolic blood pressure more than 180, diastolic blood pressure more than 110 mmHg
Liver cirrhosis
Prior treatment with CYP 3A4 inhibitors or P GlyP inductors
Treatment with anti arrhythmic medicine class ll and lll
Alcohol consumption or drug users
Simvastatin consumption

Study & Design

Study Type
interventional
Study Design
Not specified
Primary Outcome Measures
NameTimeMethod
Percentage of HbA1c. Timepoint: Per month. Method of measurement: Blood test Hitachi 911 automatic analyzer.
Secondary Outcome Measures
NameTimeMethod
Reduction of using sublingual nitroglycerin per week. Timepoint: Weekly. Method of measurement: Patient report.
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