- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT02842359
Evaluation of the Fixed-dose Combination of Irbesartan/Atorvastatin in Type 2 Diabetic Patients Diagnosed With Hyperlipidemia and Hypertension
Efficacy Evaluation of Metabolic, Anti-inflammatory, and Antioxidative Factors of Irbesartan/Atorvastatin Fixed-dose Combination in Type 2 Diabetic Patients Diagnosed With Hyperlipidemia and Hypertension, With Adequately Controlled Blood Glucose Levels
Primary Objective:
To evaluate the effect of irbesartan/atorvastatin fixed-dose combination comparing to each irbesartan and atorvastatin on flow mediated dilation change in type 2 diabetic patients diagnosed with hyperlipidemia, hypertension.
Secondary Objective:
To evaluate efficacy of blood pressure and hyperlipidemic factors of irbesartan/atorvastatin fixed-dose combination in type 2 diabetic patients diagnosed with hyperlipidemia and hypertension, with adequately controlled blood glucose levels in groups.
Study Overview
Status
Conditions
Intervention / Treatment
Detailed Description
Study Type
Enrollment (Actual)
Phase
- Phase 4
Contacts and Locations
Study Locations
-
-
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Seoul, Korea, Republic of
- Korea
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-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
Inclusion criteria:
- Patients aged ≥19 years to <75 years.
- Patients without medication history of hyperlipidemia and hypertension within 3 months following registration, among type 2 diabetic patients diagnosed with hyperlipidemia and stage I hypertension (systolic blood pressure: ≥140mmHg, ≤159 mmHg or diastolic blood pressure: ≥90 mmHg, ≤99mmHg), with adequately controlled hemoglobin levels.
- Patients who signed a written consent to data utilization.
- Diagnosis of diabetes:
- HemoglobinA1c ≥6.5% or;
- Fasting plasma glucose level above 8 hour ≥126 mg/dL or;
- Plasma glucose ≥200 mg/dL ( 11.1 mmol/l) 2 hours after a 75g glucose load or;
- Symptoms (such as polyuria, polydipsia, unexplained weight loss) and a random plasma glucose ≥200 mg/dL (11.1 mmol/L).
Exclusion criteria:
- Patients indicated as contraindication in the approved labeling of Rovelito.
- Pregnant/nursing women.
- Patients with difference in blood pressure systolic blood pressure ≥20 mmHg or diastolic blood pressure ≥10mmHg in the arm selected during screening at Visit 1.
- Patients who were administered Angiotensin II receptor blockers, angiotensin converting enzyme inhibitors, or HMG-CoA reductase inhibitors in 2 months.
- Patients who had taken antidiabetics in the past.
- Patients who have to or may take any drug suggested in the prohibited concomitant medications during the study period.
- Patients with tolerance or hypersensitivity to angiotensin II receptor blocker or HMGCoA reductase inhibitor, or an ingredient of this drug, or with history of multi-drug allergy.
- Patients with genetic angioedema, or medical history of angioedema when treating with angiotensin converting enzyme inhibitor or angiotensin II receptor antagonist
- Patients who have suffered from fibromyalgia, myopathy, rhabdomyolysis, or sudden arthralgia, or adverse events while taking statins in the past.
- Creatine phosphokinase (CPK) >5 times of the upper limit of normal (ULN).
- Patients diagnosed with secondary hypertension or suspected of secondary hypertension by the Investigator (coarctation of aorta, primary aldosteronism, renal artery stenosis, renal hypertension, pheochromocytoma, Cushing syndrome, etc.).
- Patients with poorly controlled hypothyroidism despite treatment
- Type 1 diabetic patients or poorly controlled type 2 diabetic patients (HemoglobinA1c ≥7.5%)
- Patients with arrhythmia requiring separate treatment.
- Patients with the following past history:
- Severe cerebrovascular disease (cerebral infarction, cerebral hemorrhage, etc.), hypertensive encephalopathy, transient ischemic attack (TIA), which occurred in the recent 6 months.
- Severe heart disease (NYHA class III-IV heart failure), clinically significant valvular disease of the heart, myocardial infarction and unstable angina in the recent 6 months.
- Angioplasty or coronary artery bypass graft (CABG) surgery.
- If patients have clinically significant renal or hepatic diseases , or significant hematologic test findings at screening (serum creatinine ≥ 2mg/dL, AST or ALT [aspartate transaminase or alanine transaminase] ≥3 times of the ULN).
- Patients suspected of pancreatitis or active gall bladder disease by the Investigator.
- Surgical or internal disease likely to significantly change absorption, distribution, metabolism, and elimination of drug, which falls under one of the followings (but not limited to):
- Major gastrointestinal surgical history such as gastrectomy, gastro-enterostomy or bowel resection, gastric bypass, gastrointestinal stapling, or gastrointestinal banding, medical history of active inflammatory bowel syndrome at present or in the past 12 months, current active gastritis, ulcer, gastrointestinal/rectal hemorrhage, or urinary tract obstruction that is deemed clinically significant by the Investigator.
- Patients with volume depletion, as clinically judged by the Investigator, using vital signs, skin turgor pressure, mucous membrane wettability, and laboratory values.
- All chronic inflammatory patients requiring chronic inflammatory treatment.
- Patients with past history of autoimmune disease, such as chronic rheumatoid arthritis, systemic lupus erythematosus, etc.
- Patients with past clinical history of alcohol or drug abuse.
- Patients with history of malignant tumors including leukemia and lymphoma in the past 5 years.
- Patients who have been administered another investigational product within 30 days prior to participation in this clinical study (from the time when they signed the informed consent form).
- Patients who may not be measured for flow mediated dilatation in Investigator's judgment for a congenital or secondary reason in the bilateral brachial artery.
- Patients who are deemed ineligible as subject in Investigator's judgment for other reasons.
The above information is not intended to contain all considerations relevant to a patient's potential participation in a clinical trial.
Study Plan
How is the study designed?
Design Details
- Primary Purpose: TREATMENT
- Allocation: RANDOMIZED
- Interventional Model: PARALLEL
- Masking: NONE
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
EXPERIMENTAL: Rovelito
Fixed-dose combination of irbesartan/atorvastatin will be given orally daily for 28 days
|
Pharmaceutical form:Tablet Route of administration: Oral
Other Names:
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ACTIVE_COMPARATOR: Irbesartan
Irbesartan will be given orally daily for 28 days
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Pharmaceutical form:Tablet Route of administration: Oral
Other Names:
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ACTIVE_COMPARATOR: Atorvastatin
Atorvastatin will be given orally daily for 28 days
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Pharmaceutical form:Tablet Route of administration: Oral
Other Names:
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
Change from baseline in flow mediated dilatation
Time Frame: 4 weeks, up to maximum 5 weeks
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4 weeks, up to maximum 5 weeks
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Secondary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
Rate of change from baseline in nytrotyrosine marker
Time Frame: 4 weeks, up to maximum 5 weeks
|
4 weeks, up to maximum 5 weeks
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Rate of change from baseline in Intercellular Adhesion Molecule-1
Time Frame: 4 weeks, up to maximum 5 weeks
|
4 weeks, up to maximum 5 weeks
|
Rate of change from baseline in Interleukin-6
Time Frame: 4 weeks, up to maximum 5 weeks
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4 weeks, up to maximum 5 weeks
|
Rate of change from baseline in C-reactive protein
Time Frame: 4 weeks, up to maximum 5 weeks
|
4 weeks, up to maximum 5 weeks
|
Change from baseline in blood pressure (irbesartan/atorvastatin fixed-dose combination group and irbesartan group)
Time Frame: 4 weeks, up to maximum 5 weeks
|
4 weeks, up to maximum 5 weeks
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Change from baseline in low density lipoprotein-C (irbesartan/atorvastatin fixed-dose combination group and atorvastatin group)
Time Frame: 4 weeks, up to maximum 5 weeks
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4 weeks, up to maximum 5 weeks
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Change from baseline in total cholesterol (irbesartan/atorvastatin fixed-dose combination group and atorvastatin group)
Time Frame: 4 weeks, up to maximum 5 weeks
|
4 weeks, up to maximum 5 weeks
|
Change from baseline in high density lipoprotein-C (irbesartan/atorvastatin fixed-dose combination group and atorvastatin group)
Time Frame: 4 weeks, up to maximum 5 weeks
|
4 weeks, up to maximum 5 weeks
|
Change from baseline in triglycerides (irbesartan/atorvastatin fixed-dose combination group and atorvastatin group)
Time Frame: 4 weeks, up to maximum 5 weeks
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4 weeks, up to maximum 5 weeks
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Change from baseline in apolipoprotein-A1 (irbesartan/atorvastatin fixed-dose combination group and atorvastatin group)
Time Frame: 4 weeks, up to maximum 5 weeks
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4 weeks, up to maximum 5 weeks
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Change from baseline in apolipoprotein-B (irbesartan/atorvastatin fixed-dose combination group and atorvastatin group) - Time Frame: 4 weeks, up to maximum 5 weeks
Time Frame: 4 weeks, up to maximum 5 weeks
|
4 weeks, up to maximum 5 weeks
|
Percentage of participants with decreased level of blood pressure (irbesartan/atorvastatin fixed-dose combination group and irbesartan group)
Time Frame: 4 weeks, up to maximum 5 weeks
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4 weeks, up to maximum 5 weeks
|
Rate of change from baseline in immunosenescence T cell fractionation
Time Frame: 4 weeks, up to maximum 5 weeks
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4 weeks, up to maximum 5 weeks
|
Rate of change from baseline in T-cell induced inflammatory factors
Time Frame: 4 weeks, up to maximum 5 weeks
|
4 weeks, up to maximum 5 weeks
|
Collaborators and Investigators
Sponsor
Study record dates
Study Major Dates
Study Start (ACTUAL)
Primary Completion (ACTUAL)
Study Completion (ACTUAL)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (ESTIMATE)
Study Record Updates
Last Update Posted (ACTUAL)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
- Cardiovascular Diseases
- Vascular Diseases
- Glucose Metabolism Disorders
- Metabolic Diseases
- Endocrine System Diseases
- Diabetes Mellitus
- Lipid Metabolism Disorders
- Dyslipidemias
- Hypertension
- Diabetes Mellitus, Type 2
- Hyperlipidemias
- Hyperlipoproteinemias
- Molecular Mechanisms of Pharmacological Action
- Antihypertensive Agents
- Enzyme Inhibitors
- Antimetabolites
- Anticholesteremic Agents
- Hypolipidemic Agents
- Lipid Regulating Agents
- Hydroxymethylglutaryl-CoA Reductase Inhibitors
- Angiotensin II Type 1 Receptor Blockers
- Angiotensin Receptor Antagonists
- Atorvastatin
- Irbesartan
Other Study ID Numbers
- ATOIRL07827
- U1111-1182-8092 (OTHER: UTN)
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
IPD Plan Description
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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