Evaluation of the Fixed-dose Combination of Irbesartan/Atorvastatin in Type 2 Diabetic Patients Diagnosed With Hyperlipidemia and Hypertension

NCT02842359 | Completed Phase 4

• 2 other identifiers: ATOIRL07827U1111-1182-8092
• Study Type: interventional
• Target: 11
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Type 2 Diabetes Mellitus

Outcome Measures

Primary Outcomes (1)

• Change from baseline in flow mediated dilatation

  4 weeks, up to maximum 5 weeks

Secondary Outcomes (14)

• Rate of change from baseline in nytrotyrosine marker

  4 weeks, up to maximum 5 weeks

• Rate of change from baseline in Intercellular Adhesion Molecule-1

  4 weeks, up to maximum 5 weeks

• Rate of change from baseline in Interleukin-6

  4 weeks, up to maximum 5 weeks

• Rate of change from baseline in C-reactive protein

  4 weeks, up to maximum 5 weeks

• Change from baseline in blood pressure (irbesartan/atorvastatin fixed-dose combination group and irbesartan group)

  4 weeks, up to maximum 5 weeks

Study Arms (3)

Rovelito

EXPERIMENTAL

Fixed-dose combination of irbesartan/atorvastatin will be given orally daily for 28 days

Drug: Irbesartan/atorvastatin fixed dose combination

Irbesartan

ACTIVE COMPARATOR

Irbesartan will be given orally daily for 28 days

Drug: Irbesartan SR47436

Atorvastatin

ACTIVE COMPARATOR

Atorvastatin will be given orally daily for 28 days

Drug: Atorvastatin

Interventions

Irbesartan/atorvastatin fixed dose combination DRUG

Pharmaceutical form:Tablet Route of administration: Oral

Also known as: Rovelito

Rovelito

Irbesartan SR47436 DRUG

Pharmaceutical form:Tablet Route of administration: Oral

Also known as: Aprovel

Irbesartan

Atorvastatin DRUG

Pharmaceutical form:Tablet Route of administration: Oral

Also known as: Newvast

Atorvastatin

Eligibility Criteria

• Age: 19 Years - 74 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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).

You may not qualify if:

• 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:

Sponsors & Collaborators

• Sanofi: lead

Study Sites (1)

Korea

Seoul, South Korea

Location

MeSH Terms

Conditions

Diabetes Mellitus, Type 2

Interventions

Irbesartan; Atorvastatin

Condition Hierarchy (Ancestors)

Diabetes Mellitus; Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases; Endocrine System Diseases

Intervention Hierarchy (Ancestors)

Biphenyl Compounds; Benzene Derivatives; Hydrocarbons, Aromatic; Hydrocarbons, Cyclic; Hydrocarbons; Organic Chemicals; Spiro Compounds; Tetrazoles; Azoles; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Polycyclic Compounds; Pyrroles; Heptanoic Acids; Fatty Acids; Lipids

Study Officials

• Clinical Sciences & Operations

  Sanofi

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 20, 2016
• First Posted: July 22, 2016
• Study Start: August 23, 2016
• Primary Completion: April 19, 2018
• Study Completion: April 19, 2018
• Last Updated: April 13, 2022

Record last verified: 2022-04

Data Sharing

• IPD Sharing: Will share

Locations

KR (1)