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Omarigliptin safe, well tolerated in patients with type 2 diabetes
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A once-weekly dose of omarigliptin for 12 weeks reduced HbA1c, 2-hour postprandial glucose and fasting plasma glucose in adults with type 2 diabetes, according to research in Diabetes Care.
In an additional extension study to evaluate the longer-term safety and tolerability of 25 mg omarigliptin for 66 weeks, researchers found that, when compared with placebo/metformin therapy, adverse events remained similar between treatment groups, hypoglycemia was rare and the drug was well tolerated.
The phase 2 study was designed to identify a clinical dose that could be taken forward to phase 3 clinical development.
Wayne H. H. Sheu, MD, of the division of endocrinology and metabolism at Taichung Veterans General Hospital in Taichung, Taiwan, and colleagues analyzed data from 685 adults from 21 countries with type 2 diabetes randomly assigned to one of five once-weekly doses of omarigliptin (0.25 mg, 1 mg, 3 mg, 10 mg or 25 mg) or placebo for 12 weeks. Within the cohort, 485 participants entered the 66-week extension study that immediately followed, which maintained the double blind design. Participants originally assigned omarigliptin received 25 mg for the extension study; those originally assigned placebo were switched to 30 mg pioglitazone, and later 1,000 mg metformin.
After 12 weeks of treatment, researchers found that all doses of omarigliptin reduced HbA1c and postprandial glucose when compared with placebo, and that all doses greater than 1 mg reduced FPG when compared with placebo. The 25-mg omarigliptin dose provided the greatest reduction in HbA1c (least-squares mean change from baseline vs. placebo, –0.72%), postprandial glucose (–2.5 mmol/L) and FPG (–1.3 mmol/L), according to researchers.
“In general, those subjects who were on doses of omarigliptin lower than 25 mg in the base study demonstrated additional efficacy when switched to the (higher) 25-mg dose in the extension study,” the researchers wrote.
Adverse events, including a low incidence of hypoglycemia, were similar across dose groups, and there were no reported cases of severe hypoglycemia or acute or chronic pancreatitis during either study. Additionally, there were no dose-related changes in body weight for the omarigliptin groups during the 12-week base study or the extension study, according to researchers.
“Omarigliptin 25 mg [once weekly], compared with placebo, provided significant glucose-lowering and was generally well tolerated for up to 78 weeks, establishing the 25-mg [once-weekly] dose as appropriate for further development,” the researchers wrote. “The effect of a once-weekly dosing regimen on patient medication adherence will require assessment in real-world studies in natural settings.” – by Regina Schaffer
Disclosure: Sheu reports receiving speaker honorarium and serving as a scientific adviser board member for AstraZeneca, Bayer, Boehringer Ingelheim, Bristol-Myers Squibb, Eli Lilly, Merck Sharp & Dohme, Novo Nordisk, Sanofi and Takeda. Please see the full study for a list of the other authors’ relevant financial disclosures.
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