|Systematic (IUPAC) name|
|Mol. mass||339.39 g/mol|
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Alogliptin (codenamed SYR-322) is an orally administered,anti-diabetic drug in the DPP-4 inhibitor class,developed by Takeda Pharmaceutical Company.
A randomized clinical trial reporting in 2011 aimed to determine the efficacy and safety of alogliptin versus placebo and voglibose among newly diagnosed Type 2 diabetes patients in Japan. The main outcome indicated that alogliptin was statistically superior to both comparitors.
A randomized clinical trial reporting in 2012 aimed to demonstrate that alogliptin was “non-inferior” to a “very low fat/calorie traditional Japanese diet” among newly diagnosed Type 2 diabetes patients in Japan. The outcome indicated that both the drug and dietary treatments comparably impacted indicators of the diabetic condition, such as HbA1c levels and glycemic efficacy. The drug treatment had its impact without changingbody mass index (BMI), but the dietary treatment was accompanied by a significant reduction in the BMI.
A randomized clinical trial reporting in 2011 aimed to demonstrate the efficacy of alogliptin as an add-on agent in combination with metforminand pioglitazone versus simply increasing the dosage of pioglitazone in combination with metformin; in other words, this was a study to look at a three-agent therapy versus a two-agent therapy. The outcome of this study suggested that the addition of alogliptin to metformin and pioglitazone provided superior impact on diabetes biomarkers (e.g. HbA1c) than increasing the dose of pioglitazone in a two agent therapy with metformin.
Reported adverse events
Adverse events appear to be restricted to mild hypoglycemia based on clinical studies.
In December 2007, Takeda submitted a New Drug Application (NDA) for alogliptin to the United States Food and Drug Adminiistration (USFDA),after positive results from Phase III clinical trials. In September of 2008, the company also filed for approval in Japan, winning approval in April 2010. The company also filed a Marketing Authorization Application (MAA) elsewhere outside the United States, which was withdrawn in June 2009 needing more data. The first USFDA NDA failed to gain approval and was followed by a pair of NDAs (one for alogliptin and a second for a combination of alogliptin and pioglitazone) in July 2011. In 2012, Takeda received a negative response from the USFDA on both of these NDAs, citing a need for additional data.