Type 2 Diabetes MellitusPhase 4NCT02842359
Evaluation of the Fixed-dose Combination of Irbesartan/Atorvastatin in Type 2 Diabetic Patients Diagnosed With Hyperlipidemia and Hypertension
A Phase 4 study testing Irbesartan/atorvastatin fixed dose combination, Irbesartan SR47436 and Atorvastatin in people with Type 2 Diabetes Mellitus, run by Sanofi at 1 site in South Korea.
Trial 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. Read more about this study
- Who is it for?
- Ages 19 to 74 years
- Conditions the study is for
- Type 2 Diabetes Mellitus
- What is being tested?
- Irbesartan/atorvastatin fixed dose combination, Irbesartan SR47436 and Atorvastatin
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 11 participants
- Where
- 1 siteSouth Korea
- Study dates
- 23 Aug 2016to 19 Apr 2018
- Phase
- Phase 4
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 19 to 74 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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).
Who cannot join
- 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.
Show all 31Show fewer
- 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.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: 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.
Read the detailed description
The total study duration per patient is up to maximum of 7 weeks.
- Conditions
- Type 2 Diabetes Mellitus
- Being tested
- Irbesartan/atorvastatin fixed dose combination, Irbesartan SR47436, Atorvastatin
- Medical subject headings
- Diabetes Mellitus, Type 2
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Irbesartan/atorvastatin fixed dose combinationDrug
Also called Rovelito
Pharmaceutical form:Tablet Route of administration: Oral
Irbesartan SR47436Drug
Also called Aprovel
Pharmaceutical form:Tablet Route of administration: Oral
AtorvastatinDrug
Also called Newvast
Pharmaceutical form:Tablet Route of administration: Oral
| Study group | Role | What they receive |
|---|---|---|
| Rovelito | Experimental | Fixed-dose combination of irbesartan/atorvastatin will be given orally daily for 28 days Receives: Drug: Irbesartan/atorvastatin fixed dose combination |
| Irbesartan | Active comparator | Irbesartan will be given orally daily for 28 days Receives: Drug: Irbesartan SR47436 |
| Atorvastatin | Active comparator | Atorvastatin will be given orally daily for 28 days Receives: Drug: Atorvastatin |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change from baseline in flow mediated dilatation
Measured: 4 weeks, up to maximum 5 weeks
Secondary outcomes (14)
Rate of change from baseline in nytrotyrosine marker
Measured: 4 weeks, up to maximum 5 weeks
Rate of change from baseline in Intercellular Adhesion Molecule-1
Measured: 4 weeks, up to maximum 5 weeks
Rate of change from baseline in Interleukin-6
Measured: 4 weeks, up to maximum 5 weeks
Rate of change from baseline in C-reactive protein
Measured: 4 weeks, up to maximum 5 weeks
Change from baseline in blood pressure (irbesartan/atorvastatin fixed-dose combination group and irbesartan group)
Measured: 4 weeks, up to maximum 5 weeks
Change from baseline in low density lipoprotein-C (irbesartan/atorvastatin fixed-dose combination group and atorvastatin group)
Measured: 4 weeks, up to maximum 5 weeks
Change from baseline in total cholesterol (irbesartan/atorvastatin fixed-dose combination group and atorvastatin group)
Measured: 4 weeks, up to maximum 5 weeks
Change from baseline in high density lipoprotein-C (irbesartan/atorvastatin fixed-dose combination group and atorvastatin group)
Measured: 4 weeks, up to maximum 5 weeks
Change from baseline in triglycerides (irbesartan/atorvastatin fixed-dose combination group and atorvastatin group)
Measured: 4 weeks, up to maximum 5 weeks
Change from baseline in apolipoprotein-A1 (irbesartan/atorvastatin fixed-dose combination group and atorvastatin group)
Measured: 4 weeks, up to maximum 5 weeks
Change from baseline in apolipoprotein-B (irbesartan/atorvastatin fixed-dose combination group and atorvastatin group) - Time Frame: 4 weeks, up to maximum 5 weeks
Measured: 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)
Measured: 4 weeks, up to maximum 5 weeks
Rate of change from baseline in immunosenescence T cell fractionation
Measured: 4 weeks, up to maximum 5 weeks
Rate of change from baseline in T-cell induced inflammatory factors
Measured: 4 weeks, up to maximum 5 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Jul 2016 (estimated)
- Study start23 Aug 2016
- Primary completion19 Apr 2018
- Study completion19 Apr 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Type 2 Diabetes MellitusStudies of the same condition, open and under way.
- More trials run by SanofiThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 4
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 11 participants (actual)
Sponsor and investigators
- Lead sponsor
- Sanofi
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Clinical Sciences & Operations, Study director, Sanofi
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02842359
- Sponsor's protocol ID
- ATOIRL07827
- Other IDs
- U1111-1182-8092
- Status last verified
- Apr 2022
- First submitted
- 20 Jul 2016
- Last updated
- 13 Apr 2022
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- Yes: Qualified researchers may request access to patient level data and related study documents including the clinical study report, study protocol with any amendments, blank case report form, statistical analysis plan, and dataset specifications. Patient level data will be anonymized and study documents will be redacted to protect the privacy of trial participants. Further details on Sanofi's data sharing criteria, eligible studies, and process for requesting access can be found at: https://vivli.org
Study at a glance
From the registry record, last updated by the sponsor on 13 Apr 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- 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
- ClinicalTrials.gov ID
- NCT02842359
- Acronym / sponsor ID
- ATOIRL07827
- Conditions
- Type 2 Diabetes Mellitus
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 11 participants (actual)
- Lead sponsor
- SanofiIndustry (pharma, biotech, devices)
- Study start
- 23 Aug 2016 (actual)
- Primary completion
- 19 Apr 2018 (actual)
- Study completion
- 19 Apr 2018 (actual)
- First posted
- 22 Jul 2016 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
The total study duration per patient is up to maximum of 7 weeks.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Rovelito | Experimental | Drug: Irbesartan/atorvastatin fixed dose combinationFixed-dose combination of irbesartan/atorvastatin will be given orally daily for 28 days |
| Irbesartan | Active comparator | Drug: Irbesartan SR47436Irbesartan will be given orally daily for 28 days |
| Atorvastatin | Active comparator | Drug: AtorvastatinAtorvastatin will be given orally daily for 28 days |
Who may qualify
- Ages
- 19 to 74 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (8 listed)
- 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;
Key exclusion criteria (31 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Irbesartan/atorvastatin fixed dose combinationAlso: RovelitoPharmaceutical form:Tablet Route of administration: Oral | Drug | Rovelito |
| Irbesartan SR47436Also: AprovelPharmaceutical form:Tablet Route of administration: Oral | Drug | Irbesartan |
| AtorvastatinAlso: NewvastPharmaceutical form:Tablet Route of administration: Oral | Drug | Atorvastatin |
Primary outcome
Change from baseline in flow mediated dilatation
Time frame: 4 weeks, up to maximum 5 weeks
14 secondary outcomes
Rate of change from baseline in nytrotyrosine marker
Time frame: 4 weeks, up to maximum 5 weeks
Rate of change from baseline in Intercellular Adhesion Molecule-1
Time frame: 4 weeks, up to maximum 5 weeks
Rate of change from baseline in Interleukin-6
Time frame: 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
Change from baseline in blood pressure (irbesartan/atorvastatin fixed-dose combination group and irbesartan group)
Time frame: 4 weeks, up to maximum 5 weeks
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
Change from baseline in total cholesterol (irbesartan/atorvastatin fixed-dose combination group and atorvastatin group)
Time frame: 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
Change from baseline in triglycerides (irbesartan/atorvastatin fixed-dose combination group and atorvastatin group)
Time frame: 4 weeks, up to maximum 5 weeks
Change from baseline in apolipoprotein-A1 (irbesartan/atorvastatin fixed-dose combination group and atorvastatin group)
Time frame: 4 weeks, up to maximum 5 weeks
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
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
Rate of change from baseline in immunosenescence T cell fractionation
Time frame: 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
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 Apr 2022.
- Individual participant dataSharing planned: Yes. Qualified researchers may request access to patient level data and related study documents including the clinical study report, study protocol with any amendments, blank case report form, statistical analysis plan, and dataset specifications. Patient level data will be anonymized and study documents will be redacted to protect the privacy of trial participants. Further details on Sanofi's data sharing criteria, eligible studies, and process for requesting access can be found at: https://vivli.org
Related trials for Type 2 Diabetes Mellitus
Not yet recruitingPhase 3
Efficacy and Safety of Once-Weekly SHR-3167 Compared With Once-Daily Insulin Glargine in Adults With Insulin-Naive Type 2 Diabetes
Type 2 Diabetes
Active, not recruiting
Digital Reinforcement of Motivational Interviewing Micro-Skills Among Primary Care Healthcare Professionals
Hypertension (Without Type 2 Diabetes Mellitus)
Recruiting
Investigating Vascular Properties of HEMI and SPG Signals in Individuals With or at Risk for Chronic Kidney Disease
Chronic Kidney Disease, Hypertension (HTN)
Not yet recruitingPhase 3
A Study to Evaluate the Effectiveness and Safety of the Drug AZD6234 for Managing Weight in Adults Who Are Obese or Overweight. These Participants May or May Not Also Have Type 2 Diabetes
Obesity, Overweight
Not yet recruiting
Impact of Endoscopic Sleeve Gastroplasty (ESG) in Obese Adults With Type 2 Diabetes (T2D)
Type 2 Diabetes Mellitus (T2D), Obesity (BMI>30)
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Clinical Sciences & Operations study director
Sanofi
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Irbesartan/atorvastatin fixed dose combination, Irbesartan SR47436 and Atorvastatin in people with Type 2 Diabetes Mellitus, run by Sanofi at 1 site in South Korea.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 8 inclusion and 31 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 13 Apr 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in South Korea. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change from baseline in flow mediated dilatation (time frame: 4 weeks, up to maximum 5 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 13 Apr 2022.