Roche Halts Trials on Diabetes Drug Aleglitazar
Global health care company and drug maker Roche (F. Hoffman-La Roche Ltd.) announced that it would halt trials of its experimental diabetes drug, Aleglitazar, after reports of adverse health effects in clinical trial patients.
According Roche spokesman Alexander Klauser, there is evidence that Aleglitazar was having adverse effects on patients’ hearts and kidneys while increasing the possibility of bone fractures.
“Following the results of a regular safety review of the Aleglitazar AleCardio phase III trial, the independent Data and Safety Monitoring Board (DSMB) has recommended to halt the trial due to safety signals and lack of efficacy. Based on this recommendation, Roche has decided to terminate the AleCardio trial and all other trials involving Aleglitazar,” press release.
What is Aleglitazar?
- Aleglitazar is considered a PPAR agonists, meaning it acts on peroxisome proliferator – activated recetors (PPARs) to treat metabolic syndromes which can lead to cardiovascular disease and diabetes.
- PPARs are essential in the regulation of cellular differentiation, development, and metabolism.
- A drug similar to Aleglitazar, Onglyza, was scrapped by AstraZeneca and Bristol-Meyers Squibb in 2006 when they were also unable to reduce heart risks in a large clinical study.
Side-Effects Related to Aleglitazar
- Heart problems
- Kidney problems
- Bone fractures
- Gastrointestinal disorders
- Increased creatine phosphokinase in the blood
- Upper resparatory tract infection
Aleglitazar Clinical Trials
- The clinical trials ware made up of a 6 arm study.
- Those selected for the trial were both male and female individuals between ages 18 and 75 who had been diagnosed with Type 2 diabetes.
- Over 7,000 people were entered into the trial.
- Trials were held 705 sites in 26 countries including the United States.
Aleglitazar Clinical Trial Locations (U.S.)
- Muscle Shoals
- Hawaiian Gardens
- Huntington Beach
- Long Beach
- Los Angeles
- Los Gatos
- North Hollywood
- San Diego
- Thousand Oaks
- Fort Lauderdale
- Miami Beach
- New Port Richey
- Panama City
- Pinellas Park
- Port Charlotte
- St. Petersburg
- West Palm Beach
- Winter Park
- Idaho Falls
- Melrose Park
- Iowa City
- Oxon Hill
- Traverse City
- Fall Rivers
- Kansas City
- Las Vegas
- North Massapequa
- Elizabeth City
- Jersey Shore
- Murrells Inlet
- Dakota Dunes
- Corpus Christi
- El Paso
- New Braunfels
- North Richland Hills
- San Antonio
- Salt Lake City
- Port Orchard
Roche Has a History of Diabetes Drug Failures
- Roche is a company based out of Basel, Switzerland and is a key figure in research-focused healthcare.
- While Roche is one of the largest makers of cancer drugs, there has been criticism that the company is struggling outside the field of oncology (the branch of medicine that deal with cancer).
- Roche scrapped development on their previous diabetes drug taspoglutide when a Phase III clinical trial resulted in nausea and widespread vomiting.
- Roche also halted development on its cholesterol drug dalcetrapid last year when there was shown to be a “lack of clinically meaningful efficacy.”
- Despite Roche’s current claims that it is a “frontrunner in diabetes management,” others are quick to point out Roche’s failed attempts to branch out into the field.
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