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- | aleglitazar (R1439) / Roche
Journal: Impact of age on the predictive value of NT-proBNP in patients with diabetes mellitus stabilised after an acute coronary syndrome. (Pubmed Central) - Feb 19, 2024
Among patients with T2DM stabilised after an ACS, NT-proBNP level predicts death irrespective of age.
- || aleglitazar (R1439) / Roche
Clinical, Journal: Improvement of non-invasive tests of liver steatosis and fibrosis as indicators for non-alcoholic fatty liver disease in type 2 diabetes mellitus patients with elevated cardiovascular risk profile using the PPAR-α/γ agonist aleglitazar. (Pubmed Central) - Nov 22, 2022
Among patients with T2DM stabilised after an ACS, NT-proBNP level predicts death irrespective of age. This post-hoc analysis showed improvement of non-invasive tests of liver steatosis and fibrosis after starting dual PPAR-α/γ agonist treatment, adding to the evidence that this pathway has potential in non-alcoholic fatty liver disease treatment.
- | aleglitazar (R1439) / Roche
Journal: The Glitazars Paradox: Cardiotoxicity of the Metabolically Beneficial Dual PPARα and PPARγ Activation. (Pubmed Central) - Jul 8, 2021
The objective of this review article pertains to the understanding of how combined PPARα and PPARγ activation, which successfully targets the major complications of diabetes, causes cardiac dysfunction. Furthermore, it aims to suggest interventions that will maintain the beneficial effects of dual PPARα/γ agonism and alleviate adverse cardiac outcomes in diabetes.
- || aleglitazar (R1439) / Roche
Clinical, Journal: Exposure and response analysis of aleglitazar on cardiovascular risk markers and safety outcomes: An analysis of the AleCardio trial. (Pubmed Central) - May 21, 2021
Clopidogrel is a moderate inhibitor of CYP2C8. Since aleglitazar is metabolized by CYP2C8, a pharmacokinetic interaction could explain differences in exposure and response to aleglitazar.
- | aleglitazar (R1439) / Roche
Retrospective data, Journal: Cardiovascular risk and safety evaluation of a dual peroxisome proliferator-activated receptor-alpha/gamma agonist, aleglitazar, in type 2 diabetes patients: A meta-analysis. (Pubmed Central) - Nov 4, 2020
Incidence of hypoglycemia, gastrointestinal hemorrhage, bone fractures, heart failure, cardiovascular death, and malignancy was higher in the aleglitazar group. Despite efficacy in glycemic and lipidic control, the aleglitazar treatment was associated with a poor safety profile.
- | aleglitazar (R1439) / Roche
Preclinical, Journal: Dual PPARα/γ agonist aleglitazar confers stroke protection in a model of mild focal brain ischemia in mice. (Pubmed Central) - Jun 26, 2020
Beneficial effects of aleglitazar independent of glucose regulation. Aleglitazar provides extended window of opportunity for stroke treatment.
- | aleglitazar (R1439) / Roche, Lipaglyn (saroglitazar) / Zydus Cadila
Journal: A Contemporary Overview of PPARα/γ Dual Agonists for the Management of Diabetic Dyslipidemia. (Pubmed Central) - Mar 29, 2020
Some additional and new compounds, at initial and preclinical stages, have been recently reported to possess PPARα/γ dual agonistic potentials with considerable therapeutic efficacy and reduced adverse profile. This review sheds lights on the current status of various PPARα/γ dual agonists for the management of diabetic dyslipidemia.
- | aleglitazar (R1439) / Roche
Preclinical, Journal: Beneficial Effects of the Peroxisome Proliferator-Activated Receptor α/γ Agonist Aleglitazar on Progressive Hepatic and Splanchnic Abnormalities in Cirrhotic Rats with Portal Hypertension. (Pubmed Central) - Jul 7, 2019
The present study suggested that Ale can potentially treat relevant abnormalities through the inhibition of inflammatory, vasoconstrictive, angiogenic, and mucosal-disrupted pathogenic markers in cirrhosis. Overall, chronic Ale treatment ameliorated PH syndrome by the suppression of hepatic fibrogenesis, neoangiogenesis, vasoconstrictor hyperresponsiveness, splanchnic vasodilatation, and PSS; and decreased intestinal mucosal injury and hyperpermeability in cirrhotic rats.
- | aleglitazar (R1439) / Roche
Clinical, Journal: Homeostasis Model Assessment of Insulin Resistance and Survival in Patients with Diabetes and Acute Coronary Syndrome. (Pubmed Central) - Jan 6, 2019
Baseline HOMA-IR was not associated with MACE, nor was the change in HOMA-IR on study treatment associated with death or MACE. After accounting for levels of NT-proBNP, insulin resistance assessed by HOMA-IR is not related to the risk of death or MACE in patients with T2D and ACS.
- | aleglitazar (R1439) / Roche
Clinical, Journal: Adiponectin, Free Fatty Acids, and Cardiovascular Outcomes in Patients With Type 2 Diabetes and Acute Coronary Syndrome. (Pubmed Central) - Sep 22, 2018
These findings raise the possibility that adiponectin has different effects in patients with type 2 diabetes and ACS than in populations without prevalent cardiovascular disease. Consistent with prior data, FFAs are directly associated with adverse outcomes.
- | aleglitazar (R1439) / Roche
Journal: The haemoglobin glycation index as predictor of diabetes-related complications in the AleCardio trial. (Pubmed Central) - Mar 7, 2018
The association between HGI and mortality disappeared with additional adjustment for HbA1c. HGI predicts mortality in diabetes patients with acute coronary syndromes, but no better than HbA1c.
- | aleglitazar (R1439) / Roche
Biomarker, Clinical, Journal: Predictors of mortality in hospital survivors with type 2 diabetes mellitus and acute coronary syndromes. (Pubmed Central) - Jan 6, 2018
HGI predicts mortality in diabetes patients with acute coronary syndromes, but no better than HbA1c. In patients with type 2 diabetes mellitus and recent acute coronary syndrome, mortality prediction is largely dominated by markers of cardiac, rather than metabolic, dysfunction.
- | aleglitazar (R1439) / Roche
Journal: Aleglitazar, a dual peroxisome proliferator-activated receptor-α and -γ agonist, protects cardiomyocytes against the adverse effects of hyperglycaemia. (Pubmed Central) - Oct 12, 2017
In patients with type 2 diabetes mellitus and recent acute coronary syndrome, mortality prediction is largely dominated by markers of cardiac, rather than metabolic, dysfunction. Aleglitazar protects cardiomyocytes against hyperglycaemia-induced apoptosis by combined activation of both peroxisome proliferator-activated receptor-α and peroxisome proliferator-activated receptor-γ in a short-term vitro model.
- | aleglitazar (R1439) / Roche
Journal: Post-Discharge Worsening Renal Function in Patients with Type 2 Diabetes and Recent Acute Coronary Syndrome: Impact on Long Term Outcome. (Pubmed Central) - Sep 21, 2017
Aleglitazar protects cardiomyocytes against hyperglycaemia-induced apoptosis by combined activation of both peroxisome proliferator-activated receptor-α and peroxisome proliferator-activated receptor-γ in a short-term vitro model. Post-discharge worsening renal function is not infrequent among patients with type 2 diabetes and acute coronary syndromes with normal or mildly depressed renal function, and is a strong predictor of adverse cardiovascular events.
- | aleglitazar (R1439) / Roche
Journal: Aleglitazar, a Balanced Dual PPARα and -γ Agonist, Protects the Heart Against Ischemia-Reperfusion Injury. (Pubmed Central) - Feb 27, 2017
Post-discharge worsening renal function is not infrequent among patients with type 2 diabetes and acute coronary syndromes with normal or mildly depressed renal function, and is a strong predictor of adverse cardiovascular events. Ale protects against myocardial apoptosis caused by hypoxia-reoxygenation in vitro and reduces infarct size in vivo.
- || aleglitazar (R1439) / Roche
Trial primary completion date: A Comparison of the Effects of Aleglitazar and Actos on Renal Function on Patients With Type 2 Diabetes. (clinicaltrials.gov) - Aug 1, 2016
P2, N=176, Completed, Sponsor: Hoffmann-La Roche
Ale protects against myocardial apoptosis caused by hypoxia-reoxygenation in vitro and reduces infarct size in vivo. Trial primary completion date: Apr 2009 --> Sep 2008
- |||| aleglitazar (R1439) / Roche
Trial primary completion date: A Study With Aleglitazar in Patients With a Recent Acute Coronary Syndrome and Type 2 Diabetes Mellitus (clinicaltrials.gov) - May 11, 2014
P3, N=7226, Completed, Sponsor: Hoffmann-La Roche
Trial primary completion date: Apr 2009 --> Sep 2008 Trial primary completion date: Jan 2014 --> Nov 2013
- ||||| aleglitazar (R1439) / Roche
Trial initiation date: A Study With Aleglitazar in Patients With a Recent Acute Coronary Syndrome and Type 2 Diabetes Mellitus (clinicaltrials.gov) - May 11, 2014
P3, N=7226, Completed, Sponsor: Hoffmann-La Roche
Trial primary completion date: Jan 2014 --> Nov 2013 Initiation date: Jan 2010 --> Feb 2010
- ||| aleglitazar (R1439) / Roche
Trial completion date: A Study With Aleglitazar in Patients With a Recent Acute Coronary Syndrome and Type 2 Diabetes Mellitus (clinicaltrials.gov) - May 11, 2014
P3, N=7226, Completed, Sponsor: Hoffmann-La Roche
Initiation date: Jan 2010 --> Feb 2010 Trial completion date: Jan 2014 --> Nov 2013
- | aleglitazar (R1439) / Roche
Trial completion, Monotherapy: A Study to Evaluate the Effect of Aleglitazar on Cardiac Energetics and Function in Patients With Type 2 Diabetes Mellitus and no History of Coronary Artery Disease (clinicaltrials.gov) - Apr 6, 2014
P2, N=18, Completed, Sponsor: Hoffmann-La Roche
Trial completion date: Jan 2014 --> Nov 2013 Active, not recruiting --> Completed
- ||||||| aleglitazar (R1439) / Roche
Trial completion, Monotherapy: A Study of Aleglitazar in Patients With Type 2 Diabetes Mellitus Who Have Not Previously Received Anti-Hyperglycemic Therapy (clinicaltrials.gov) - Jan 19, 2014
P3, N=196, Completed, Sponsor: Hoffmann-La Roche
Active, not recruiting --> Completed Recruiting --> Completed
- ||||||| aleglitazar (R1439) / Roche
Trial completion: A Study With Aleglitazar in Patients With a Recent Acute Coronary Syndrome and Type 2 Diabetes Mellitus (clinicaltrials.gov) - Jan 12, 2014
P3, N=7226, Completed, Sponsor: Hoffmann-La Roche
Recruiting --> Completed Active, not recruiting --> Completed
- aleglitazar (R1439) / Roche
Enrollment change, Combination therapy, Monotherapy: A Study of Aleglitazar in Combination With Metformin in Patients With Type 2 Diabetes Mellitus Who Are Inadequately Controlled With Metformin Monotherapy (clinicaltrials.gov) - Nov 12, 2013
P3, N=7, Completed, Sponsor: Hoffmann-La Roche
Active, not recruiting --> Completed N=400 --> 7
- aleglitazar (R1439) / Roche
Trial completion, Combination therapy, Monotherapy: A Study of Aleglitazar in Combination With Metformin in Patients With Type 2 Diabetes Mellitus Who Are Inadequately Controlled With Metformin Monotherapy (clinicaltrials.gov) - Nov 12, 2013
P3, N=7, Completed, Sponsor: Hoffmann-La Roche
N=400 --> 7 Recruiting --> Completed
- ||||||| aleglitazar (R1439) / Roche
Trial completion: A Study on The Potential of Aleglitazar to Reduce Cardiovascular Risk in Patients With Stable Cardiovascular Disease and Glucose Abnormalities (clinicaltrials.gov) - Nov 12, 2013
P3b, N=1999, Completed, Sponsor: Hoffmann-La Roche
Recruiting --> Completed Active, not recruiting --> Completed
- ||| aleglitazar (R1439) / Roche
Enrollment change, Monotherapy: A Study of The Effect of Aleglitazar on Insulin Sensitivity in Patients With Type 2 Diabetes Mellitus Who Are Inadequately Controlled With Metformin (clinicaltrials.gov) - Nov 6, 2013
P2, N=57, Completed, Sponsor: Hoffmann-La Roche
Active, not recruiting --> Completed N=80 --> 57
- |||| aleglitazar (R1439) / Roche
Trial completion, Monotherapy: A Study of The Effect of Aleglitazar on Insulin Sensitivity in Patients With Type 2 Diabetes Mellitus Who Are Inadequately Controlled With Metformin (clinicaltrials.gov) - Nov 6, 2013
P2, N=57, Completed, Sponsor: Hoffmann-La Roche
N=80 --> 57 Recruiting --> Completed
- ||||| aleglitazar (R1439) / Roche
Enrollment change: A Study on The Potential of Aleglitazar to Reduce Cardiovascular Risk in Patients With Stable Cardiovascular Disease and Glucose Abnormalities (clinicaltrials.gov) - Nov 3, 2013
P3b, N=1999, Completed, Sponsor: Hoffmann-La Roche
Recruiting --> Completed N=19000 --> 1999
- | aleglitazar (R1439) / Roche
Enrollment change, Monotherapy: A Study of Aleglitazar in Monotherapy in Patients With Type 2 Diabetes Mellitus Who Are Drug-Na (clinicaltrials.gov) - Oct 6, 2013
P3, N=13, Completed, Sponsor: Hoffmann-La Roche
N=19000 --> 1999 N=400 --> 13
- || aleglitazar (R1439) / Roche
Trial completion, Monotherapy: A Study of Aleglitazar in Monotherapy in Patients With Type 2 Diabetes Mellitus Who Are Drug-Na (clinicaltrials.gov) - Oct 6, 2013
P3, N=13, Completed, Sponsor: Hoffmann-La Roche
N=400 --> 13 Recruiting --> Completed
- ||||||| aleglitazar (R1439) / Roche
Trial completion, Combination therapy, Monotherapy: A Study of Aleglitazar in Combination With Metformin in Patients With Type 2 Diabetes Mellitus Who Are Inadequately Controlled With Metformin Alone (clinicaltrials.gov) - Oct 6, 2013
P3, N=200, Completed, Sponsor: Hoffmann-La Roche
Recruiting --> Completed Recruiting --> Completed
- | aleglitazar (R1439) / Roche
Enrollment change, Monotherapy: A Study to Evaluate the Effect of Aleglitazar on Cardiac Energetics and Function in Patients With Type 2 Diabetes Mellitus and no History of Coronary Artery Disease (clinicaltrials.gov) - Sep 24, 2013
P2, N=18, Completed, Sponsor: Hoffmann-La Roche
Recruiting --> Completed N=28 --> 18
- ||||||| aleglitazar (R1439) / Roche
Trial completion, Combination therapy, Monotherapy: A Study of Aleglitazar in Combination With Metformin in Patients With Type 2 Diabetes Mellitus Who Are Inadequately Controlled With Sulfonylurea Alone or Sulfonylurea Plus Metformin Therapy (clinicaltrials.gov) - Sep 8, 2013
P3, N=197, Completed, Sponsor: Hoffmann-La Roche
N=28 --> 18 Active, not recruiting --> Completed
- aleglitazar (R1439) / Roche
Trial withdrawal: A Study of Alegitazar in Patients With Type 2 Diabetes And Chronic Kidney Disease (Alerenal Study) (clinicaltrials.gov) - Jul 22, 2013
P3, N=0, Withdrawn, Sponsor: Hoffmann-La Roche
Active, not recruiting --> Completed Not yet recruiting --> Withdrawn
- aleglitazar (R1439) / Roche
Enrollment change: A Study of Alegitazar in Patients With Type 2 Diabetes And Chronic Kidney Disease (Alerenal Study) (clinicaltrials.gov) - Jul 22, 2013
P3, N=0, Withdrawn, Sponsor: Hoffmann-La Roche
Not yet recruiting --> Withdrawn N=5100 --> 0
- aleglitazar (R1439) / Roche
New P3 trial: A Study of Alegitazar in Patients With Type 2 Diabetes And Chronic Kidney Disease (Alerenal Study) (clinicaltrials.gov) - Jul 4, 2013
P3, N=0, Withdrawn, Sponsor: Hoffmann-La Roche
- ||| aleglitazar (R1439) / Roche
New P3 trial, Monotherapy: A Study of Aleglitazar in Monotherapy in Patients With Type 2 Diabetes Mellitus Who Are Drug-Na (clinicaltrials.gov) - Jun 4, 2013
P3, N=13, Completed, Sponsor: Hoffmann-La Roche
- | aleglitazar (R1439) / Roche
New P3 trial, Combination therapy, Monotherapy: A Study of Aleglitazar in Combination With Metformin in Patients With Type 2 Diabetes Mellitus Who Are Inadequately Controlled With Metformin Monotherapy (clinicaltrials.gov) - Jun 4, 2013
P3, N=7, Completed, Sponsor: Hoffmann-La Roche
- | aleglitazar (R1439) / Roche
Trial completion: A Comparative Study of Aleglitazar and Actos in Patients With Type 2 Diabetes Mellitus and New York Heart Association (NYHA) Class II Heart Failure. (clinicaltrials.gov) - May 22, 2013
P2, N=14, Completed, Sponsor: Hoffmann-La Roche
N=5100 --> 0 Terminated --> Completed
- | aleglitazar (R1439) / Roche
Trial completion, Combination therapy: A Study of Aleglitazar in Combination With Oral Contraceptive Healthy Volunteers (clinicaltrials.gov) - Apr 28, 2013
P1, N=18, Completed, Sponsor: Hoffmann-La Roche
Terminated --> Completed Active, not recruiting --> Completed
- | aleglitazar (R1439) / Roche
Trial completion: A Pharmacokinetic Study of Aleglitazar in Healthy Chinese Volunteers (clinicaltrials.gov) - Jan 13, 2013
P1, N=16, Completed, Sponsor: Hoffmann-La Roche
Active, not recruiting --> Completed Active, not recruiting --> Completed
- | aleglitazar (R1439) / Roche
Trial completion, Combination therapy: A Pharmacokinetics Study of Aleglitazar in Combination With Digoxin in Healthy Volunteers (clinicaltrials.gov) - Jan 13, 2013
P1, N=28, Completed, Sponsor: Hoffmann-La Roche
Active, not recruiting --> Completed Recruiting --> Completed
- | aleglitazar (R1439) / Roche
Trial completion: A Study to Investigate the Effects of Rifampicin on the Pharmacokinetics of Aleglitazar in Healthy Volunteers (clinicaltrials.gov) - Jan 13, 2013
P1, N=24, Completed, Sponsor: Hoffmann-La Roche
Recruiting --> Completed Not yet recruiting --> Completed
- ||| aleglitazar (R1439) / Roche
Trial completion: A Pharmacodynamic/Pharmacokinetic Study of Aleglitazar in Patients With Type 2 Diabetes Mellitus on Treatment With Lisinopril (clinicaltrials.gov) - Jan 13, 2013
P1, N=55, Completed, Sponsor: Hoffmann-La Roche
Not yet recruiting --> Completed Active, not recruiting --> Completed
- |||| aleglitazar (R1439) / Roche
Trial completion: A Study of Aleglitazar in Type 2 Diabetes Patients With Moderate Renal Impairment (clinicaltrials.gov) - Jan 2, 2013
P2, N=302, Completed, Sponsor: Hoffmann-La Roche
Active, not recruiting --> Completed Active, not recruiting --> Completed
- ||||| aleglitazar (R1439) / Roche
New P2 trial, Monotherapy: A Study of The Effect of Aleglitazar on Insulin Sensitivity in Patients With Type 2 Diabetes Mellitus Who Are Inadequately Controlled With Metformin (clinicaltrials.gov) - Nov 18, 2012
P2, N=57, Completed, Sponsor: Hoffmann-La Roche
- | aleglitazar (R1439) / Roche
New P1 trial: A Pharmacokinetic Study of Aleglitazar in Healthy Chinese Volunteers (clinicaltrials.gov) - Oct 18, 2012
P1, N=16, Completed, Sponsor: Hoffmann-La Roche
- | aleglitazar (R1439) / Roche
New P1 trial, Combination therapy: A Pharmacokinetics Study of Aleglitazar in Combination With Digoxin in Healthy Volunteers (clinicaltrials.gov) - Oct 3, 2012
P1, N=28, Completed, Sponsor: Hoffmann-La Roche
- |||||||||| aleglitazar (R1439) / Roche
New P3 trial, Combination therapy, Monotherapy: A Study of Aleglitazar in Combination With Metformin in Patients With Type 2 Diabetes Mellitus Who Are Inadequately Controlled With Sulfonylurea Alone or Sulfonylurea Plus Metformin Therapy (clinicaltrials.gov) - Sep 23, 2012
P3, N=197, Completed, Sponsor: Hoffmann-La Roche
- |||||||||| aleglitazar (R1439) / Roche
New P3 trial, Monotherapy: A Study of Aleglitazar in Patients With Type 2 Diabetes Mellitus Who Have Not Previously Received Anti-Hyperglycemic Therapy (clinicaltrials.gov) - Sep 23, 2012
P3, N=196, Completed, Sponsor: Hoffmann-La Roche